Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

Start Date26 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06946524

/ Not yet recruitingPhase 1

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to Prefilled Syringe

This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.

Start Date22 Apr 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06937619

/ RecruitingPhase 1

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.

Start Date21 Apr 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Risankizumab-RZAA

100 Translational Medicine associated with Risankizumab-RZAA

100 Patents (Medical) associated with Risankizumab-RZAA

612

Literatures (Medical) associated with Risankizumab-RZAA

01 Jun 2025·AUTOIMMUNITY REVIEWS

The role of interleukin inhibitors in the treatment of hidradenitis suppurativa; a systematic review of clinical trials

Review

Author: Eghbali, Sara ; Ghane, Yekta ; Lotfi, Zahra ; Heidari, Nazila ; Heidari, Amirhossein ; Hajikarim-Hamedani, Arman ; Pishraft-Sabet, Homayoun ; Goodarzi, Azadeh

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disorder that presents significant treatment challenges. Recent advancements have enhanced our understanding of its pathophysiology, leading to the development of novel therapeutic strategies. This systematic review evaluates the role of interleukin (IL) inhibitors as emerging treatment options for HS. A systematic search was conducted in PubMed/Medline, Scopus, and Web of Science databases for studies published up to September 2nd, 2024, with inclusion limited to clinical trials available in English. The National Institute of Health (NIH) Quality Assessment Tool for clinical trials and before-after studies with no control group was used to assess the methodological quality of the included studies. Out of 1289 studies, 20 met our inclusion criteria involving 3957 patients. Moreover, four ongoing trials were retrieved from ClinicalTrials.gov. Secukinumab showed sustained hidradenitis Suppurativa Clinical Response (HiSCR) improvements, particularly in biologic-naïve patients with common adverse events (AEs). Bimekizumab was effective with biweekly dosing, while the four-week regimen had inconsistent results, with rare reports of AEs. Brodalumab and bermekimab provided rapid and sustained HiSCR responses with lesion reductions, which were well tolerated. Guselkumab and ustekinumab showed promising but statistically nonsignificant improvements with mild AEs. Risankizumab did not significantly improve HiSCR rates but showed Dermatology Life Quality Index (DLQI) benefits. Anakinra offered moderate efficacy with prolonged exacerbation-free periods but led to some treatment discontinuations. Spesolimab reduced inflammatory lesions and draining tunnels while maintaining a favorable safety profile. IL inhibitors, especially IL-17 inhibitors, have demonstrated efficacy in treating moderate-to-severe HS, while IL-23 inhibitors have shown inconsistent results. Despite their generally favorable safety profiles, further research is needed to optimize treatment strategies and assess long-term outcomes.

01 May 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Effectiveness and safety of risankizumab dose optimization in adult patients with plaque psoriasis: An international multicentre retrospective cohort study

Letter

Author: Yeung, J ; Torres, T ; Rankin, B ; Zaaroura, H ; Mufti, A ; Vender, R ; Bagit, A ; Prajapati, V H ; Mansour, M ; Park, Y J ; Georgakopoulos, J R ; Le, A M ; Wang, E ; Maliyar, K ; Lytvyn, Y

10 Apr 2025·encephalitis

Acyclovir-induced sinus bradycardia: a case report and literature review

Article

Author: Mikerov, Gregory ; Darwish, Ilyse ; Goldman, Gail

In this report, we describe the case of a 51-year-old female who presented to our emergency department with varicella zoster infection. Her relevant medical history included rheumatoid arthritis which was treated with risankizumab. Intravenous acyclovir therapy was initiated due to concern for disseminated disease as she was experiencing T4 dermatomal involvement and new-onset scalp pain. On day 3 of antiviral therapy, the patient developed a sinus bradycardia of 35 beats/min. This persisted until 3 days after the discontinuation of acyclovir. This is the third reported case of sinus bradycardia potentially linked to acyclovir administration. Thus, clinicians should consider intravenous acyclovir as a possible cause of de novo sinus bradycardia.

352

News (Medical) associated with Risankizumab-RZAA

20 hours ago

·www.prnewswire.com

Spyre Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update

On track for mid-year initiations of planned Phase 2 studies in ulcerative colitis ("UC") and rheumatoid arthritis ("RA"), providing for 7+ proof-of-concept readouts in 2026 & 2027 Reported extended follow-up Phase 1 data for SPY001, supporting that the molecule is well tolerated, has a pharmacokinetic ("PK") profile enabling quarterly or biannual dosing, and provides complete target engagement at expected Phase 2 trough concentrations Remain on track to report interim Phase 1 data for SPY002 later this quarter, with the potential to demonstrate a product profile superior to first-generation TL1A antibodies Announced first participant dosed in Phase 1 trial of SPY003, with interim PK and safety data readout on track for the second half of 2025 $565 million of cash, cash equivalents, and marketable securities as of March 31, 2025, with expected runway into the second half of 2028 WALTHAM, Mass., May 8, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. ("Spyre" or the "Company") (NASDAQ:SYRE), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD") and other immune-mediated diseases, today announced its first quarter 2025 financial results and provided program and corporate updates. "We continued to efficiently execute on our ambitious strategy this quarter - presenting longer-term SPY001 Phase 1 data that further supports its potential best-in-class profile, continuing dosing with our SPY002 molecules in parallel Phase 1 trials, and initiating our fourth Phase 1 trial within nine months with SPY003," said Cameron Turtle, DPhil., Chief Executive Officer. "This quarter, we look forward to sharing interim SPY002 Phase 1 data which has the potential to demonstrate a best-in-class profile for the treatment of IBD and other immune-mediated diseases, as well as a second optimized component of our potentially paradigm-changing investigational combination therapies. Following these data, we plan to embark on two fully funded, groundbreaking Phase 2 trials that will provide 7+ proof-of-concept readouts in markets with annual revenues totaling approximately $50B. With de-risked biology, an experienced team, and a strong balance sheet, we are focused on delivering against our plans to redefine the standard-of-care in IBD and beyond while providing a transformative set of catalysts for our investors." Development Pipeline Overview and Update The Company's approach combines best-in-class antibody engineering, dose optimization, and rational therapeutic combinations with the goal of maximizing efficacy, safety, and convenience in the treatment of IBD and other immune-mediated diseases. IBD is a chronic condition characterized by inflammation within the gastrointestinal tract, including two main disorders: UC and Crohn's disease ("CD"). In the United States, it is estimated that approximately 2.4 million individuals are diagnosed with IBD. RA is a chronic inflammatory autoimmune condition that primarily affects the joints but also other parts of the body. It is characterized by pain, stiffness, and swelling of one or more joints and can progress from mild swelling of the joints in early stages to severe deformations of the feet, ankles, and hands in late/severe stages. RA affects more than 1.5 million individuals in the United States. The Company has three programs in clinical development, all of which are targets in IBD validated by third parties. All three validated targets offer the potential for safe and effective treatment of UC and CD, with infrequent, subcutaneous maintenance dosing as a monotherapy or in rational combinations. The Company is also planning to study its anti-TL1A program in additional indications outside IBD, beginning with RA. SPY001 – a highly potent and selective investigational monoclonal antibody targeting α4β7, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. In May 2025, extended follow up data were presented at Digestive Disease Week ("DDW") 2025 from the Phase 1 healthy volunteer trial, demonstrating a favorable safety profile across all dose groups, a meaningfully differentiated PK profile with half-life estimate of more than three times that of vedolizumab that remains supportive of potential Q6M maintenance dosing, and rapid and complete saturation of α4β7 receptors beyond six months with a single dose of 600mg. Based on these interim results, Spyre plans to advance SPY001 to a Phase 2 clinical trial in UC patients in mid-2025. SPY002 – a program with two highly potent and selective, investigational anti-TL1A monoclonal antibodies, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. The Company believes TL1A has emerged as one of the most promising targets in IBD and broader immunology indications. In January 2025, the Company announced its intent to study one of its anti-TL1A antibodies in RA, with Phase 2 trial initiation expected in mid-2025 and topline results in 2026. With class-leading potency and half-life established in preclinical studies, SPY002 has the potential to become the first-in-class and best-in-class anti-TL1A treatment for RA. In December 2024, the Company announced initiation of first-in-human ("FIH") trials of both SPY002 candidates, with healthy volunteer interim data expected in the second quarter of 2025. If successful, the Company expects one or more SPY002 candidates would then advance to Phase 2 clinical trials. In October 2024, preclinical data for both SPY002 development candidates were presented at the United European Gastroenterology Week ("UEGW") Congress demonstrating superior or comparable in vitro potency to first-generation anti-TL1As, as well as a pharmacokinetic half-life of 24 days in non-human primates ("NHPs"), which represents a two to three-fold increase compared to these same first-generation anti-TL1As. SPY003 – a highly potent and selective investigational monoclonal antibody targeting the p19 subunit of IL-23, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. In March 2025, the Company initiated a FIH trial of SPY003, with healthy volunteer interim data expected in the second half of 2025. In October 2024, preclinical data for SPY003 were presented for the first time at UEGW, demonstrating comparable potency to risankizumab, as well as a pharmacokinetic half-life of 30 days in NHPs, greater than three-fold compared to risankizumab. These data also demonstrated that SPY003 exhibits high selectivity and affinity for IL-23 and potently inhibits downstream cellular signaling. Rational Combinations – the Company plans to investigate combinations of our proprietary antibodies in nonclinical studies and clinical trials in order to evaluate whether combination therapy can potentially lead to best-in-class efficacy in IBD, with less frequent dosing. In February and May 2025, preclinical data for SPY120 were presented at various medical meetings, demonstrating that the combined inhibition of TL1A and α4β7 is superior to either monotherapy in mouse models of colitis and that coadministration of SPY001 and SPY002 demonstrated no drug effects on PK in NHPs. In October 2024, preclinical data for SPY130 and SPY230 were presented at UEGW, demonstrating enhanced efficacy and pharmacodynamics with SPY003 in combination with SPY001 and with SPY002. The Company expects to initiate a Phase 2 clinical trial in 2025 that is intended to include each of its rational combinations, as well as all three of its lead monotherapy programs. First Quarter 2025 Financial Results Cash Position: As of March 31, 2025, Spyre had cash, cash equivalents, and marketable securities of $564.8 million. Net cash used in operating activities was $41.0 million for the first quarter of 2025. Research and Development (R&D) expenses: R&D expenses totaled $41.6 million for the first quarter of 2025 and $34.9 million for the first quarter of 2024. The increase was primarily driven by higher clinical and nonclinical development expenses, offset partially by lower antibody discovery costs. General and Administrative (G&A) expenses: G&A expenses totaled $11.9 million for the first quarter of 2025 and $12.8 million for the first quarter of 2024. Other income (expense): Other income totaled $8.8 million for the first quarter of 2025 and $3.9 million for the first quarter of 2024. The increase was primarily driven by higher interest earned on the Company's cash and marketable securities as well as a change in fair value of the contingent value right liability. Net Loss: Net loss totaled $44.8 million and $43.9 million for the first quarters of 2025 and 2024, respectively, which includes non-cash stock-based compensation expense of $8.9 million and $13.8 million for the first quarters of 2025 and 2024, respectively. About Spyre Therapeutics Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, please visit . Safe Harbor / Forward Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact, are forward-looking statements. These forward-looking statements include statements regarding the Company's future results of operations and financial position; its business strategy, including the Company's ability to successfully develop best-in-class and/or first-in-class therapeutics for IBD, RA, or other immune-mediated diseases that meaningfully improve both efficacy and convenience compared to today's standard of care; the SPY002 Phase I data potential to demonstrate a product profile superior to first generation TL1As; the SPY001 Phase 1 trial final data readouts not being consistent with or being different than the interim Phase 1 results; the expected timing for receipt of interim data, including interim Phase 1 data for SPY002 and SPY003; the sufficiency of the Company's funding to support the development of its assets, including expectations of cash runway extending into the second half of 2028 and being sufficient to fully fund two planned Phase 2 trials in UC and RA providing for 7+ proof-of-concept readouts in 2026 and 2027; the length of time that the Company believes its existing cash resources will fund its operations; estimated market sizes and potential growth opportunities; its nonclinical and future clinical development activities, including expected timing of each cohort for the platform Phase 2 trial in UC; the expected number of proof-of-concept readouts to be delivered; the expected advancement of one or more SPY002 candidates to Phase 2 trials; clinical trial designs, including the Company's planned platform Phase 2 trial in UC, and related regulatory feedback; further clinical evaluation of therapeutic combinations; the potential efficacy, tolerability, convenience, commercial viability and safety profile of its product candidates, including in combinations; the planned dosing regimen for SPY001 and our other product candidates, including the potential for a Q3M or Q6M dosing profile; the potential therapeutic benefits and economic value of its product candidates as monotherapies or in combinations and their extended half-life; the timing for initiation of nonclinical studies and clinical trials, including the Phase 2 trials in UC and RA; and the planned expansion of SPY002 into RA and other indications, including timing thereof. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "predict," "target," "intend," "could," "would," "should," "project," "plan," "expect," the negatives of these terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the expected or potential impact of macroeconomic conditions, including inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in tariff/trade and monetary policy, the prospect of a shutdown of the U.S. federal government, volatile market conditions, financial institution instability, as well as geopolitical instability, including the ongoing military conflict in Ukraine, conflicts in the middle east, and geopolitical tensions between the United States and other countries, including China, on the Company's operations, the implementation of measures that restrict international trade by the United States, China or other governments, the potential impacts of the BIOSECURE Act or similar act if passed into law and those risks described in the Company's Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, as well as in other filings and reports that the Company makes from time to time with the Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for the Company's management to predict all risks, nor can the Company assess the impact of all factors on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. The Company undertakes no obligation to update publicly any forward-looking statement for any reason after the date of this press release to conform these statements to actual results, to reflect changes in the Company's expectations, or otherwise, except as required by law. You should read press release with the understanding that the Company's actual results, levels of activity, performance, events, outcomes, and the timing of results and outcomes, and other circumstances may be materially different from what the Company expects. SOURCE Spyre Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Financial StatementPhase 2Immunotherapy

05 May 2025

·www.prnewswire.com

TREMFYA® (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks

TREMFYA® subcutaneous induction demonstrates significant rates of clinical remission and endoscopic improvement at Week 24 in ulcerative colitis Findings build on recent FDA-approval of both routes of administration for induction therapy with TREMFYA® in Crohn's disease SAN DIEGO, May 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the Phase 3 ASTRO study evaluating TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adults with moderately to severely active ulcerative colitis (UC). The ASTRO Week 24 data build on the Week 12 SC induction data that showed statistically significant and clinically meaningful improvements compared to placebo across all clinical and endoscopic measures consistent with the U.S. Food and Drug Administration (FDA)-approved intravenous (IV) induction regimen evaluated in this population, in the Phase 3 QUASAR study.1,2 TREMFYA® is the first and only IL-23 inhibitor to demonstrate robust results with a fully SC regimen. These findings are among 24 abstracts highlighting the Company's research being presented at Digestive Disease Week (DDW) 2025. Data at Week 24 show patients treated with TREMFYA® 400 mg SC induction followed by SC maintenance dose regimens of either 100 mg every eight weeks (q8w) or 200 mg every four weeks (q4w) demonstrated statistically significant and clinically meaningful improvements across all clinical and endoscopic measures compared with patients receiving placebo.1 "Data from the ASTRO study demonstrate that subcutaneous induction treatment with TREMFYA provides clinically meaningful remission in patients with ulcerative colitis, similar to the effects seen with intravenous induction," said Millie Long, M.D., MPH, Professor of Gastroenterology and Hepatology at the University of North Carolina at Chapel Hill and study investigator.e "The availability of both subcutaneous and intravenous induction options would offer physicians and patients greater flexibility in their treatment approach." Furthermore, at Week 24, in prespecified analyses of subpopulations defined by prior advanced therapy treatment status, TREMFYA® demonstrated statistically significant results across endpoints in both biologic and JAK inhibitor-naïve and biologic and JAK inhibitor-refractory patients. Safety data from the ASTRO study were consistent with the well-established safety profile of TREMFYA®.1 "These results highlight the potential of TREMFYA to redefine ulcerative colitis care with a fully subcutaneous induction and maintenance regimen that offers a convenient option with meaningful clinical and endoscopic improvements," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "Our goal is to reshape UC care and empower prescribers with a differentiated and effective treatment that offers the option of patient self-administration from day one." TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.3,4,5,6,7 TREMFYA® received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. In November 2024, a supplemental Biologics License Application (sBLA) was submitted to the FDA seeking approval of a SC induction regimen of TREMFYA® for the treatment of adults with moderately to severely active UC. TREMFYA® was also approved by the FDA in March 2025 for SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease (CD). For a full list of all data being presented at DDW visit: Editor's Notes: a. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore of 0, or 1 with no friability present on the endoscopy. b. Symptomatic remission per Mayo score is defined as a stool frequency subscore of 0 (normal number of stools) or 1 (1 to 2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). c. Endoscopic improvement was defined as an endoscopy subscore of 0 or 1 with no friability present on the endoscopy. d. Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. e. Dr. Long is a paid consultant for Johnson & Johnson. She has not been compensated for any media work. ABOUT THE ASTRO STUDY (NCT05528510) ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study designed to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients (n = 418) were randomized 1:1:1 to receive TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA® 200 mg SC every 4 weeks (q4w); or TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA® 100 mg SC every 8 weeks (q8w); or placebo. The maintenance dose regimens in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program which established the efficacy and safety profile of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.8 ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.9 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease.5 TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. In addition, TREMFYA ® is approved in Europe, Japan and Brazil for the treatment of adult patients with moderately to severely active UC and in Brazil and China for the treatment of adults with moderately to severely active CD. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting , by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.   Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.  Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. References: 1 Peyrin-Biroulet, et al. Efficacy and safety of subcutaneous guselkumab induction therapy in patients with Ulcerative Colitis: Results through week 12 from the phase 3 ASTRO study. Results from the Phase 3 ASTRO study. Oral presentation (#OP10) at the 20th Congress of the European Crohn's and Colitis Organization (ECCO). February 2025. 2 Long M, et al. Efficacy And Safety Of Subcutaneous Guselkumab Induction Therapy In Patients With Ulcerative Colitis: Results Through Week 24 From The Phase 3 Astro Study. Oral presentation (#4241895) at Digestive Disease Week 2025. May 2025. 3 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 4 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 5 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 6 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 7 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 8 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: NCT05528510. . Accessed March 2025. 9 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed March 2025 SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

05 May 2025

·www.prnewswire.com

TREMFYA® (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years

Data from the QUASAR long-term extension study demonstrate more than 70% of patients were in clinical remission and more than 40% of patients were in endoscopic remission at Week 92 SAN DIEGO, Calif., May 5, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from the TREMFYA® (guselkumab) Phase 3 QUASAR long-term extension (LTE) study in adults with moderately-to-severely active ulcerative colitis (UC). These data are among 24 abstracts highlighting the Company's research being presented at Digestive Disease Week (DDW) 2025. Data from the QUASAR LTE study demonstrate patients treated with TREMFYA® sustained clinical and endoscopic efficacy at Week 92: a, 1 72% of patients were in clinical remissionb with 99% of those patients remaining corticosteroid free for 8 or more weeks through Week 92. 43% of patients were in endoscopic remission.c Among patients achieving endoscopic improvementd at Week 44, 84% maintained endoscopic improvement through Week 92. Patients treated with TREMFYA® sustained clinical and endoscopic remission regardless of prior biologic and/or JAK inhibitor treatment history. "People living with ulcerative colitis seek treatments that both address the challenging symptoms of the disease and provide durable results," said Gary R. Lichtenstein, Vice Chief, Division of Gastroenterology and Hepatology, Development and Philanthropy at the University of Pennsylvania.e "These new data show TREMFYA delivers long-term, sustained clinical and endoscopic remission, marking important progress in UC care." Safety data were consistent with the well-established safety profile of TREMFYA® in inflammatory bowel disease (IBD) with no new safety concerns identified. "With these findings, TREMFYA shows the powerful impact it can have in achieving longer term remission in patients," said Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "This is a significant step forward in our mission to reshape the standard of care in inflammatory bowel disease." TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.2,3,4,5,6 TREMFYA® received FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. In November 2024, a supplemental Biologics License Application (sBLA) was submitted to the FDA seeking approval of a SC induction regimen of TREMFYA® for the treatment of adults with moderately to severely active UC. TREMFYA® was also approved by the FDA in March 2025 for SC and IV induction options for the treatment of adults with moderately to severely active Crohn's disease (CD). For a full list of all data being presented at DDW visit:   Editor's Notes: a. Nonresponder imputation results. Data were analyzed using 2 methods: 'nonresponder imputation' (NRI) accounting for patients with treatment failure or missing data, and 'as observed'. NRI results were consistent with as observed. b. Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopic subscore (MES) of 0 or 1. c. Endoscopic remission (normalization) was defined as a MES of 0. d. Endoscopic improvement was defined as a MES of 0 or 1. e. Dr. Lichtenstein has received honorarium for his role as a consultant to Johnson & Johnson. He has not been compensated for any media work. ABOUT THE QUASAR PROGRAM (NCT04033445) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA® in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the Phase 3 induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the Phase 3 maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo.7 The ongoing long-term extension study provides an additional 4 years of treatment. Efficacy, safety, pharmacokinetics, immunogenicity, and biomarkers are assessed at specified time points. ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.8 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease.4 TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. In addition, TREMFYA ® is approved in Europe, Japan and Brazil for the treatment of adult patients with moderately to severely active UC and in Brazil and China for the treatment of adults with moderately to severely active CD. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting , by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.   Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.  Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. References: 1 Lichtenstein GR, et al. Efficacy And Safety Of Guselkumab For Ulcerative Colitis Through Week 92 Of The Quasar Long-Term Extension Study. Poster presentation (#4241842) at Digestive Disease Week 2025. May 2025. 2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504 3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 7 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. . Accessed March 2025. 8 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed March 2025 SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

100 Deals associated with Risankizumab-RZAA

External Link

KEGG	Wiki	ATC	Drug Bank
-	Risankizumab-RZAA	L04AC18	DB14762

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	China	AbbVie, Inc.	04 Mar 2025
Crohn's disease, active severe	China	AbbVie, Inc.	04 Mar 2025
Colitis, Ulcerative	Japan	AbbVie, Inc.	26 Sep 2022
Crohn Disease	Australia	AbbVie Pty Ltd.	16 Jul 2019
Ulcerative colitis, active moderate	Australia	AbbVie Pty Ltd.	16 Jul 2019
Ulcerative colitis, active severe	Australia	AbbVie Pty Ltd.	16 Jul 2019
Plaque psoriasis	Canada	AbbVie, Inc.	17 Apr 2019
Arthritis, Psoriatic	Japan	AbbVie, Inc.	26 Mar 2019
Erythrodermic psoriasis	Japan	AbbVie, Inc.	26 Mar 2019
Psoriasis vulgaris	Japan	AbbVie, Inc.	26 Mar 2019
Pustular psoriasis	Japan	AbbVie, Inc.	26 Mar 2019
Pustulosis of Palms and Soles	Japan	AbbVie, Inc.	26 Mar 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	Phase 3	United States	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Australia	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Canada	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	France	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Germany	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Italy	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Poland	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Spain	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	United Kingdom	AbbVie, Inc.	08 Jul 2024
Keratoderma, Palmoplantar	Phase 3	United States	AbbVie, Inc.	26 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADVANCE, MOTIVATE, FORTIFY (Pubmed \| J Crohns Colitis)	Phase 3	Perianal fistula due to Crohn's disease Maintenance high-sensitivity C-reactive protein (hs-CRP) \| fecal calprotectin (FCP)	748	Risankizumab 600 mg	xduwzcercu(yjmleplsmr) = nofdntjzbl sxaohxdylh (xdylncqncy ) View more	Positive	04 Apr 2025
				Risankizumab 180 mg	xduwzcercu(yjmleplsmr) = buaiikqvux sxaohxdylh (xdylncqncy ) View more
NCT03105128 (MOTIVATE, ADVANCE, FORTIFY, Pubmed \| Clin Gastroenterol Hepatol)	Phase 3	Perianal fistula due to Crohn's disease anti-interleukin-23 p19 monoclonal antibody	-	Risankizumab 1200 mg IV	pfneviepmz(dazalihumi) = gtpmdydshh cacoaadhpq (neffycaxfi ) View more	Positive	01 Feb 2025
				Risankizumab 180 mg SC	pfneviepmz(dazalihumi) = pdofwcpwwx cacoaadhpq (neffycaxfi ) View more
FORTIFY (Pubmed \| Gastro Hep Adv)	Phase 3	Crohn Disease Maintenance	-	Risankizumab	rfbxldgocr(aausxdtryy) = cjmpiskjdb coemxthbdj (wfwbbdudfc )	Positive	01 Jan 2025
NCT03047395 (LIMMitless, CTgov)	Phase 3	Plaque psoriasis	2,170	Risankizumab	temmniajvm = uumjkvcrbu ebcxkjxzla (rmmeacllmr, neqlsebvyh - mfcptgjetj) View more	-	11 Dec 2024
NCT04524611 (SEQUENCE, UEGW2024)	Phase 3	Crohn Disease high-sensitivity C-reactive protein \| fecal calprotectin	-	Risankizumab	ogzamxvmes(tybiyxvdml) = lvpttnuwdr rkjzsfjvfq (tcpcuaotwp, 22.0 - 35.6) View more	Positive	13 Oct 2024
				Ustekinumab	ogzamxvmes(tybiyxvdml) = tfeygiejam rkjzsfjvfq (tcpcuaotwp, 8.8 - 18.9) View more
NCT04524611 (SEQUENCE, UEGW2024)	Phase 3	Crohn Disease	-	Risankizumab	pukdcsskmf(jfhgegaail) = ejzdpfhhhq fhlccsqppp (gikmakxizd, 48.2 - 79.6) View more	Positive	13 Oct 2024
				Ustekinumab	pukdcsskmf(jfhgegaail) = ozpvkklkdv fhlccsqppp (gikmakxizd, 36.2 - 66.1) View more
NCT03398148 \| NCT03398135 (INSPIRE \| COMMAND, UEGW2024)	Phase 3	Colitis, Ulcerative Maintenance high-sensitivity C-reactive protein	650	Risankizumab 1200 mg IV	bwluoxcjea(eyxxoenpce) = eecemnukvw vxmbbufkrs (bdfbwitmee, 18.4 - 26.8) View more	Positive	13 Oct 2024
				Placebo IV	bwluoxcjea(eyxxoenpce) = tobvwigqwa vxmbbufkrs (bdfbwitmee, 4.1 - 11.9) View more
UEGW2024	Not Applicable	Ulcerative colitis, active moderate	-	Risankizumab 1200 mg IV	evvkhjeaft(wqyhzydrbg) = cjjkahwotq ydqhresyof (lxehehxsxb )	-	13 Oct 2024
				Placebo IV	evvkhjeaft(wqyhzydrbg) = ggwcmypytz ydqhresyof (lxehehxsxb )
NCT03105102 (FORTIFY, UEGW2024)	Phase 3	Crohn's disease, active moderate Maintenance interleukin-23 p19 subunit	710	Risankizumab 180 mg	ubjgyuttpj(crvkfgfivr) = iohexwwruv stdwtemczw (jpduvemdrq ) View more	Positive	13 Oct 2024
				Risankizumab 360 mg	ubjgyuttpj(crvkfgfivr) = dtxfydmbjc stdwtemczw (jpduvemdrq ) View more
NCT04524611 (SEQUENCE, UEGW2024)	Phase 3	Crohn Disease	-	Risankizumab	pchtypyaze(kpvidjivwk) = kkosprfapm cptybzmdjl (dodbotvlra ) View more	Positive	13 Oct 2024
				Ustekinumab	pchtypyaze(kpvidjivwk) = hwvbdguhpr cptybzmdjl (dodbotvlra ) View more

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