A Continuation Protocol for Deucravacitinib in Patients With Patients With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132

Start Date17 Mar 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT06869551

/ RecruitingPhase 3

A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.

Start Date10 Mar 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT05821374

/ Not yet recruitingEarly Phase 1IIT

Novel Treatment of Pyoderma Gangrenosum With Deucravacitinib

The main goal of this study is to see if the study drug called "Deucravacitinib" is safe and effective in treating people with pyoderma gangrenosum (PG).

Start Date01 Mar 2025

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

[+1]

100 Clinical Results associated with Deucravacitinib

100 Translational Medicine associated with Deucravacitinib

100 Patents (Medical) associated with Deucravacitinib

263

Literatures (Medical) associated with Deucravacitinib

31 Dec 2025·ANNALS OF MEDICINE

Cardiovascular safety of Janus kinase inhibitors in inflammatory bowel disease: a systematic review and network meta-analysis

Review

Author: Wang, Bangmao ; Yang, Huibin ; Zhang, Qingyu ; Zhao, Yuxuan ; An, Ting ; Shi, Xiaojing

BACKGROUND AND OBJECTIVE:

Janus kinase (JAK) inhibitors (JAKinibs) are effective for inflammatory bowel disease (IBD), but their cardiovascular safety is inconclusive. We aim to assess the cardiovascular risks associated with JAKinibs in IBD patients.

PATIENTS AND METHODS:

Systematic searches of seven databases and ClinicalTrials.gov from inception to February 2024 were conducted. Outcomes included major adverse cardiovascular events (MACE), venous thromboembolism events (VTE) and cardiovascular events (CVE), which were separately evaluated based on whether or not the dose was considered. P-score was applied to rank interventions.

RESULTS:

A total of 26 trials involving 10,537 IBD patients were included, and results showed no significantly increased risk of MACE, VTE and CVE was associated with JAKinibs. However, when the dose was considered, Tofacitinib 5 mg BID (versus placebo) showed a trend towards an increased risk of MACE [odds ratio (OR)=1.05, 95% confidence interval (CI): 0.23-4.82], as well as Upadacitinib 30 mg QD (versus placebo) showed a trend towards increased risks of VTE (OR=1.36, 95% CI: 0.23-8.03) and CVE (OR=1.08, 95% CI: 0.24-4.85), and ranked higher than placebo for the risk of VTE [P-score=0.766 (versus 0.722)]. Notably, Deucravacitinib ranked lowest for all cardiovascular risks, and significantly decreased the risks of VTE (OR=0.03, 95% CI: 0.00-0.87) and CVE (OR=0.03, 95% CI: 0.00-0.87) compared with placebo.

CONCLUSIONS:

Although a trend of increased cardiovascular risks was found considering dose, no significantly increased cardiovascular risk was associated with JAKinibs in IBD patients, and Deucravacitinib significantly decreased the risks of VTE and CVE.

01 Apr 2025·ANTI-CANCER DRUGS

Dual inhibition of TYK2 and PD-L1 boosts immune response in triple negative breast cancer

Article

Author: Xiang, Huali ; Tu, Binfeng ; Feng, Xin ; Huang, Yajuan ; Chen, Linjing

Recent studies have shown that Janus Kinase inhibitors can enhance the tumor therapeutic effect of immune checkpoint inhibitors. However, it remains to be studied whether TYK2 selective inhibitors can enhance the therapeutic effect of small molecule PD-L1 inhibitors in triple-negative breast cancer (TNBC). We verified the efficacy of the combination of the selective TYK2 inhibitor Deucravacitinib and the small molecule inhibitor of PD-L1, INCB086550, in two TNBC animal models: a syngeneic mouse model (4T1 with humanized PD-L1) and a peripheral blood mononuclear cell (PBMC)-humanized model (MDA-MB-231). Following that, we explored the regulation of immune cell activity in tumors by the combined treatment using flow cytometry. Finally, we validated the expression of genes related to the regulated immune cells through reverse transcription-PCR. Both animal models demonstrated that the addition of a TYK2 inhibitor to a PD-L1 inhibitor significantly enhanced the antitumor capabilities of mice with good safety profiles. The combined therapy significantly elevated the counts of T, B, and natural killer cells while concurrently diminishing myeloid-derived suppressor cells in the syngeneic model. Similarly, in the PBMC-humanized model, this therapy markedly augmented progenitor-like and proliferative precursor-like CD8 T cells, while effectively diminishing exhausted and terminally differentiated CD8 T cell populations. This enhanced antitumor effect is associated with the modulation of antitumor immune-related gene expression by the combined therapy. The combination of TYK2 inhibitors and immune checkpoint inhibitors is a potentially effective strategy for treating TNBC.

04 Mar 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

A focused report on IFN-1 targeted therapies for lupus erythematosus

Review

Author: Furie, Richard ; Vashistha, Himanshu ; Bhatt, Anushka ; Gupta, Pramiti

INTRODUCTION:

Patients with Systemic Lupus Erythematosus (SLE) experience varied manifestations and unpredictable flares, complicating treatment and drug development. Despite these challenges, anifrolumab, voclosporin, and belimumab were approved by FDA. These treatments complement, but don't replace, traditional therapies like NSAIDs, corticosteroids, antimalarials, and immunosuppressives. Therefore, there remains an unmet need for more effective medications targeting excessive proinflammatory cytokines in SLE patients.

AREAS COVERED:

This review summarizes the clinical trial outcomes of four upcoming medications targeting cytokine activity: Litifilimab showed a 7-point reduction in CLASI-A in its phase II trial. Daxdilimab was unsuccessful in its phase II trial. Anifrolumab reduced SLE activity in both phase II and III trials. Deucravacitinib decreased disease activity by multiple measures in its phase II trial.

EXPERT OPINION:

High levels of IFN-I (type 1 interferon) are present in most SLE patients, making this pathway an attractive target for drug development. Litifilimab downregulates IFN-I by targeting BDCA2, while dexadilimab targets ILT7 to recruit effector cells, reducing IFN-I production by killing PDCs. Anifrolumab binds to the IFN-I receptor, blocking the activity of all IFN-Is, and deucravacitinib reduces IFN-I by inhibiting TYK2, thereby interfering with downstream signaling. Therapies that target IFN-I represents a promising class of medications for SLE patients.

223

News (Medical) associated with Deucravacitinib

21 Mar 2025

·www.biospace.com

J&J Wins Crohn’s Expansion for Tremfya as Stelara Biosimilars Enter US Market

iStock, Sundry Photography The label expansion couls help J&J establish Tremfya as a successor to Stelara, which is now facing a growing biosimilar challenge. The FDA signed off on the use of Johnson & Johnson ’s Tremfya Thursday to treat adults with moderately to severely active Crohn’s disease. As per the pharma’s news release, Tremfya is the “first and only” IL-23 blocker that can be used intravenously and subcutaneously for this indication. The label expansion should help J&J to better position Tremfya as a successor to its blockbuster drug Stelara. Earlier this year, the first four Stelara biosimilars hit the U.S. market, led by Amgen’s Wezlana in January . Teva and Alvotech’s Selarsdi , Sandoz’s Pyzchiva and Biocon Biologics’ Yesintek followed suit in the subsequent weeks. Adding to J&J’s challenges in trying to market Stelara is a September 2024 announcement from Cigna Evernorth Health Services, one of the biggest insurance providers in the U.S., that it would offer a Stelara copycat this year at $0 out-of-pocket cost. First approved in 2017 for moderate to severe plaque psoriasis, Tremfya is a human IgG1 monoclonal antibody that targets the IL-23 cytokine, blocking its interaction with its corresponding receptor. Through this mechanism of action, Tremfya suppresses the release of proinflammatory factors, in turn dampening inflammation that underlies several immune-mediated diseases. The biologic has also been approved for psoriatic arthritis and, most recently, ulcerative colitis . Thursday’s label expansion for Tremfya is backed by data from several Phase III trials evaluating the biologic in more than 1,300 patients with Crohn’s disease who had failed or were otherwise intolerant to corticosteroids, immunomodulators or other biologics. In its GRAVITI study, subcutaneous Tremfya led to significantly better clinical remission and endoscopic response than placebo. Tremfya beat out Stelara in terms of all pooled endoscopic endpoints in GALAXI, making it the only IL-23 blocker to best the blockbuster in a double-blinded pivotal program, according to Thursday’s release. Chris Gasink, J&J’s vice president for Medical Affairs, Gastroenterolgy & Autoantibody said Thursday’s approval not only provides patients with a new effective treatment option but also gives them “the flexibility of self-administration from the start.” The pharma is also seeking approval for a subcutaneous formulation of Tremfya for ulcerative colitis. Elsewhere in its immunology business, J&J earlier this month released Phase III findings for investigational oral IL-23 receptor blocker icotrokinra, touting its superiority over Bristol Myers Squibb’s Sotyktu in plaque psoriasis. J&J believes that icotrokinra could become the “new standard of treatment” in this indication.

Phase 3Drug ApprovalClinical ResultBiosimilarImmunotherapy

12 Mar 2025

·www.prnewswire.com

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultPhase 2

11 Mar 2025

·pmlive.com

J&J/Protagonist’s icotrokinra shows promise in phase 3 plaque psoriasis programme

Johnson & Johnson (J&J) and Protagonist Therapeutics have announced new data from a late-stage programme of their investigational targeted oral peptide in plaque psoriasis. Results from the phase 3 ICONIC-LEAD study presented at this year’s American Academy of Dermatology (AAD) annual meeting showed that the candidate, icotrokinra (JNJ-2113), was associated with significant skin clearance in adults and adolescents aged 12 years and older with moderate-to-severe cases of the immune-mediated skin disease. More than 125 million people worldwide are estimated to be living with plaque psoriasis, which causes inflamed, scaly plaques. These can occur anywhere on the body and may be itchy or painful. Icotrokinra is designed to selectively block the IL-23 receptor, which plays a vital role in the pathogenic T-cell activation of the condition and other immune-mediated inflammatory diseases. In ICONIC-LEAD, 65% of patients receiving once daily icotrokinra achieved an Investigator’s Global Assessment (IGA) score of zero or one (clear or almost clear skin) and 50% achieved at least a 90% improvement on the Psoriasis Area and Severity Index (PASI 90), compared to 8% and 4% of those randomised to receive placebo, respectively, at week 16. Continued skin clearance improvement was also reported at week 24, with 74% of icotrokinra-treated patients achieving an IGA score of zero or one and 65% reaching PASI 90. Additionally, 46% of patients receiving icotrokinra achieved IGA zero and 40% reached PASI 100 at week 24. ICONIC-LEAD study investigator, Robert Bissonnette, Innovaderm Research, said: “These study results are promising, and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favourable safety profile in a once daily pill.” The companies also shared promising results from the phase 3 ICONIC-ADVANCE 1 and 2 studies, which are evaluating icotrokinra against both placebo and deucravacitinib in adults with moderate-to-severe plaque plaque psoriasis, and announced the initiation “the first-ever head-to-head study in plaque psoriasis seeking to demonstrate the superiority of an oral pill… compared to an injectable biologic”. Icotrokinra was jointly discovered and is being developed under a licence and collaboration agreement between Protagonist and J&J. J&J has exclusive worldwide rights to develop the candidate in mid-stage clinical trials and beyond, and to commercialise compounds derived from the research conducted in accordance with the agreement against a broad range of indications.

Phase 3Clinical ResultLicense out/inASCO

100 Deals associated with Deucravacitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11817	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Erythrodermic psoriasis	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Psoriasis vulgaris	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Pustular psoriasis	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Plaque psoriasis	United States	Bristol Myers Squibb Co.	09 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sjogren's Syndrome	Phase 3	United States	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	China	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Japan	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Argentina	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Australia	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Austria	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Belgium	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Brazil	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Bulgaria	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	Canada	Bristol Myers Squibb Co.	11 Sep 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05478499 (CTgov)	Phase 4	Psoriasis of scalp	154	Deucravacitinib	jmawltknsu = sqgkrtlshb xfsfestkhr (mmrclzlqtc, dkvqwzvzea - ymtgfbcmgm) View more	-	13 Mar 2025
NCT04908189 (POETYK PsA-2 \| IM011-055, NEWS) Manual	Phase 3	Arthritis, Psoriatic	730	氘可来昔替尼	xdvqdqmldc(vggexukdta) = vrrvyjhsia osjgehwfkx (lcyuqadtav ) Met View more	Positive	10 Mar 2025
				安慰剂	xdvqdqmldc(vggexukdta) = osgeeyfjee osjgehwfkx (lcyuqadtav ) Met View more
NCT03624127 \| NCT04036435 \| NCT03611751 (POETYK PSO-LTE, PipelineReview) Manual	Phase 3	Plaque psoriasis	-	deucravacitinib (1-year)	saaygewtlh(qzezwkoiho) = gbzwgrticl couyfrmqze (msoqkqdtww ) View more	Positive	17 Feb 2025
				deucravacitinib (5-year)	saaygewtlh(qzezwkoiho) = jgekaigbqw couyfrmqze (msoqkqdtww ) View more
NCT04908189 (POETYK PsA-2, Company_Website) Manual	Phase 3	Arthritis, Psoriatic	730	deucravacitinib	kjcnvlszhc(klvaokkkqw) = significantly greater proportion of Sotyktu -treated patients achieving ACR20 response. nfwasourkh (kvzoqfusfq ) Met View more	Positive	23 Dec 2024
				Placebo
NCT04908202 (POETYK PsA-1, Company_Website) Manual	Phase 3	Arthritis, Psoriatic	670	deucravacitinib	beahadaurp(bymmnkuquf) = significantly greater proportion of Sotyktu -treated patients achieving ACR20 response. hiyblgycqf (hqzcrszyxp ) Met View more	Positive	23 Dec 2024
				Placebo
NCT03624127 \| NCT04036435 \| NCT03611751 (POETYK PSO-1, PSO-2, and LTE trials, Pubmed \| JAMA Dermatol)	Phase 3	Plaque psoriasis	1,519	Deucravacitinib 6 mg once daily	stplzchgca(stvnfdudjw) = uaseawsiip wmmkzwhddi (uizlssdaiz, 215.4 - 243.9) View more	Positive	27 Nov 2024
				Apremilast 30 mg twice daily	stplzchgca(stvnfdudjw) = protmskifd wmmkzwhddi (uizlssdaiz, 137.1 - 153.0) View more
NCT04877990 (CTgov)	Phase 2	Crohn Disease \| Colitis, Ulcerative	67	Deucravacitinib (BMS-986165) (Crohn's Disease)	xxejsluqfn = fsozulwnjp arrkvzxvlw (uxlcmnnlfg, uvfdceucox - qcnnunemop) View more	-	24 Sep 2024
				Deucravacitinib (BMS-986165) (Ulcerative Colitis)	xxejsluqfn = kvktrrrfbg arrkvzxvlw (uxlcmnnlfg, hznbkqmosb - oghizojlfv) View more
NCT04613518 (CTgov)	Phase 2	Colitis, Ulcerative	38	BMS-986165 (BMS-986165 12 mg BID)	jwkcytzakk = nskkdyigip thhminxdur (wbatyplleu, fxnisydzdu - unipsfsvog) View more	-	12 Jul 2024
				Placebo (Placebo BID PO)	jwkcytzakk = xsemwkhbuq thhminxdur (wbatyplleu, jnujlsbkmf - dwsfgfhtay) View more
NCT03599622 (CTgov)	Phase 2	Crohn Disease	239	Placebo	uwzhunkwpd = rpuewktzyl svpmolxsmq (jdyjhajiuf, indmbelaxp - vtdgscsvye) View more	-	03 Jul 2024
NCT03252587 (PAISLEY, EULAR2024) Manual	Phase 2	Systemic Lupus Erythematosus antinuclear antibody \| anti-double-stranded DNA \| anti-Smith antibody	363	Deucravacitinib 3mg BID	vfnazqvykr(tltxbyvmru) = wcqavrcntb jlnejgwwkq (nczqaugnke, 2.7) View more	Positive	05 Jun 2024
				Deucravacitinib 6mg BID	vfnazqvykr(tltxbyvmru) = jcucesyiqt jlnejgwwkq (nczqaugnke, 2.6) View more

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