A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis

This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- < 18 years) and adults (18-75 years) with moderate to severe AD.

Start Date15 Oct 2024

Sponsor / Collaborator

Simcere Pharmaceutical Group Ltd.

NCT06488755 / Not yet recruitingPhase 3

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SIM0718 in Adults and Adolescents With Asthma

Phase III clinical study of SIM0718 asthma

Start Date10 Jul 2024

Sponsor / Collaborator

Simcere Pharmaceutical Group Ltd.

CTR20242160 / RecruitingPhase 3

一项多中心、随机、双盲、平行组、安慰剂对照，评价SIM0718在成人和青少年中重度特应性皮炎患者中的有效性和安全性的III期临床研究

[Translation] A multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of SIM0718 in adults and adolescents with moderate to severe atopic dermatitis

主要研究目的：评估SIM0718在中重度AD受试者中的有效性。次要研究目的： 1）评估SIM0718在中重度AD受试者中的安全性 2）评估SIM0718在中重度AD受试者中的药代动力学（PK）和药效学（PD）特征 3）评估SIM0718的免疫原性

[Translation]

Primary study objectives: To evaluate the efficacy of SIM0718 in subjects with moderate to severe AD. Secondary study objectives: 1) To evaluate the safety of SIM0718 in subjects with moderate to severe AD 2) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of SIM0718 in subjects with moderate to severe AD 3) To evaluate the immunogenicity of SIM0718

Start Date04 Jul 2024

Sponsor / Collaborator

Suzhou Connect Biopharma Co. Ltd.

100 Clinical Results associated with Rademikibart

100 Translational Medicine associated with Rademikibart

100 Patents (Medical) associated with Rademikibart

Literatures (Medical) associated with Rademikibart

02 Jul 2024·Expert opinion on emerging drugs

Emerging drugs for the treatment of atopic dermatitis: a focus on phase 2 and phase 3 trials

Review

Author: Su, Malcolm ; Ong, Peck Y. ; Obed, Ogechi ; Chong, Albert C.

INTRODUCTION:

Atopic dermatitis (AD) is an inflammatory skin condition that affects millions of pediatric and adult patients with well-studied impact on morbidity and quality of life. Management occurs in a stepwise fashion beginning with preventative measures before immunomodulators are introduced. However, challenges remain in treatment of moderate-to-severe atopic dermatitis that is refractory to first- and second-line treatments and there are only few topical anti-inflammatory options, especially for pediatric patients.

AREAS COVERED:

New medications are required to address these gaps as lesions may persist despite treatment or patients may discontinue treatment due to actual or anticipated adverse effects of mainstay medications. Emerging research into the pathophysiology of AD and the immune system at large has provided opportunities for novel interventions aimed at stopping AD mechanisms at new checkpoints. Clinical trials for 36 agents currently in phase 2 or phase 3 are evaluated with particular focus on the studies for, B244, CBP-201, tapinarof, lebrikizumab, nemolizumab, amlitelimab, and rocatinlimab as they explore novel pathways and have some of the most promising results.

EXPERT OPINION:

These clinical trials contribute to the evolution of AD treatment toward greater precision based on salient pathways with a particular focus on moderate-to-severe AD to enhance efficacy and minimize adverse effects.

01 Apr 2024·The Journal of allergy and clinical immunology

Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001)

Article

Author: Pan, Wubin ; Ho, Selwyn ; Song, Jing ; Silverberg, Jonathan I ; Strober, Bruce ; Wei, Zheng ; Li, Pauline ; Guo, Jiawang ; Yun, Jang ; Xu, Jinhua ; Simpson, Eric L ; Guttman-Yassky, Emma ; Collazo, Raúl ; Longphre, Malinda ; Williams, Belinda ; Feinstein, Brian

BACKGROUND:

Rademikibart (CBP-201) is a next-generation IL-4 receptor alpha-targeting antibody.

OBJECTIVE:

We sought to evaluate rademikibart in adults with moderate to severe atopic dermatitis.

METHODS:

A total of 226 patients were randomized, double-blind, to subcutaneous rademikibart (300 mg every 2 weeks [Q2W], 150 mg Q2W, 300 mg every 4 weeks [Q4W]; plus 600-mg loading dose) or placebo. Randomization began in July 2020. The trial was completed in October 2021.

RESULTS:

The WW001 phase 2 trial achieved its primary end point: significant percent reduction from baseline in least-squares mean Eczema Area Severity Index (EASI) to week 16 with rademikibart 300 mg Q2W (-63.0%; P = .0007), 150 mg Q2W (-57.6%; P = .0067), 300 mg Q4W (-63.5%; P = .0004) versus placebo (-39.7%). EASI scores decreased significantly with 300 mg Q2W and Q4W at the earliest assessment (week 2), with no evidence of plateauing by week 16. Significant improvements were also observed in secondary end points, including pruritus. Across the primary and secondary end points, efficacy tended to be comparable with 300 mg Q2W and Q4W dosing. Rademikibart and placebo had similar, low incidence of treatment-emergent adverse events (TEAEs) (48% vs 54%), serious TEAEs (1.8% vs 3.6%), TEAEs leading to treatment discontinuation (1.2% vs 1.8%), conjunctivitis of unspecified cause (2.9% vs 0%), herpes (0.6% vs 1.8%), and injection-site reactions (1.8% vs 1.8%). Although no discontinuations were attributed to coronavirus disease 2019, pandemic-related restrictions likely had an impact on trial conduct.

CONCLUSIONS:

Rademikibart was efficacious and well tolerated at Q2W and Q4W intervals. Q4W dosing is a more convenient frequency than approved for current therapies.

01 Dec 2023·Dermatology and therapy

A Mini Review of the Impact of Baseline Disease Severity on Clinical Outcomes: Should We Compare Atopic Dermatitis Clinical Trials?

Review

Author: Collazo, Raúl ; Silverberg, Jonathan I ; Ho, Selwyn

Based on clinical trials of systemic treatments in adults with moderate-to-severe atopic dermatitis (AD) reported between 2014 and 2023, we used linear regression to investigate relationships between baseline Eczema Area and Severity Index (EASI) scores and (1) study start date, (2) EASI response, and (3) rescue medication rates. Analysis 1 was conducted with all patients from monotherapy and combination therapy trials; analyses 2 and 3 used monotherapy trial placebo arms. Across 32 trials with a baseline inclusion criterion of EASI ≥ 16, baseline mean EASI scores decreased with study start date. The lowest and highest baseline mean EASI scores were 25.1 and 33.6 (median 21.1 and 30.5), reported for the WW001 Phase 2 trial of rademikibart (formerly CBP-201; start date, July 2020) and the SOLO1 Phase 3 trial of dupilumab (start date, December 2014), respectively. In placebo arms, lower baseline EASI scores tended to be associated with greater percent reductions in EASI scores at Week 16 and less rescue medication usage. The WW001 trial placebo arm had the lowest baseline EASI score (mean 25.2; median 22.1), lowest rescue medication rate (14.3%), and a large reduction in least squares mean EASI scores (- 39.7%) at Week 16. In summary, baseline mean EASI scores have decreased across clinical trials conducted during the last decade. Less severe AD at baseline tended to be associated with greater placebo response and less use of rescue medications in placebo arms. Intertrial differences in variables, such as baseline AD severity, limit the validity of indirectly comparing clinical trials.

News (Medical) associated with Rademikibart

06 Nov 2024

·www.prnewswire.com

Severe Asthma Clinical Trial Pipeline Appears Robust With 40+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

The severe asthma market is fueled by the rising prevalence of the condition, particularly in urban areas, alongside the emergence of innovative therapies like biologics targeting IgE and cytokine modulators. A growing demand for personalized medicine enhances treatment efficacy and patient compliance. Government initiatives and increased awareness improve access to care, while advancements in inhaler technology boost medication adherence. Collaborative efforts in R&D are also vital for driving innovation in asthma treatments. LAS VEGAS, Nov. 6, 2024 /PRNewswire/ -- DelveInsight's ' Severe Asthma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline severe asthma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the severe asthma pipeline domain. Key Takeaways from the Severe Asthma Pipeline Report DelveInsight's severe asthma pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for severe asthma treatment. Key severe asthma companies such as Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others are evaluating new severe asthma drugs to improve the treatment landscape. Promising severe asthma pipeline therapies such as KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others are under different phases of severe asthma clinical trials. In September 2024, Kinaset Therapeutics announced two oral presentations and a late-breaking poster presentation at the 2024 European Respiratory Society (ERS) Congress. The presentations demonstrate the potential of Kinaset's lead clinical candidate, frevecitinib ( KN-002), to treat all patients with moderate to severe asthma and patients with COPD. In May 2024, GSK announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterized by blood eosinophil count. In April 2024, Twenty-five abstracts across approved and investigational medicines will be presented at this year's American Thoracic Society (ATS) International Conference. Notable data presentations for Sanofi's immunology pipeline include the first presentation of phase IIb moderate to severe asthma data for rilzabrutinib. In October 2023, Upstream Bio announced positive interim results in its Phase Ib clinical study of UPB-101, a thymic stromal lymphopoietin receptor (TSLPR) inhibitor. The Phase Ib study is a randomized, double-blinded, placebo-controlled multiple ascending dose (MAD) study with subcutaneous (SC) administration conducted in asthma patients. In October 2023, Aiolos Bio with an asthma drug in clinical trials, announced that it raised $245 million in Series A funding. Atlas Venture, Bain Capital Life Sciences, Forbion Capital Partners and Sofinnova Investments led the round, with additional investment from RA Capital Management Request a sample and discover the recent advances in severe asthma treatment drugs @ Severe Asthma Pipeline Report The severe asthma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage severe asthma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the severe asthma clinical trial landscape. Severe Asthma Overview Severe asthma is a chronic respiratory condition characterized by persistent symptoms that are difficult to control, even with high-dose medications. Unlike milder forms of asthma, severe asthma can significantly impair the quality of life and may result in frequent exacerbations requiring hospitalization. The exact cause of severe asthma is not entirely clear, but it often arises from a combination of genetic and environmental factors. These may include respiratory infections, allergens (pollen, mold, dust mites), pollutants (tobacco smoke, air pollution), occupational irritants, and lifestyle factors such as obesity and stress. Severe asthma can also develop in people whose milder asthma is not well-controlled over time. Diagnosis of severe asthma begins with a comprehensive medical history, physical examination, and pulmonary function tests like spirometry to assess lung function. Doctors may also order additional tests, such as chest X-rays, blood tests, and allergy tests to identify triggers. A key factor in diagnosing severe asthma is the persistence of symptoms despite the optimal use of standard asthma treatments. Managing severe asthma typically requires a multifaceted approach. Inhaled corticosteroids and long-acting bronchodilators are the mainstays of treatment. For those who do not respond to these medications, biologic therapies (such as omalizumab, mepolizumab, or dupilumab) may be prescribed to target specific pathways involved in the inflammatory response. In addition, patients with severe asthma may benefit from lifestyle modifications, including weight management, avoiding triggers, and pulmonary rehabilitation. In extreme cases, systemic corticosteroids may be necessary, although long-term use can have serious side effects. Find out more about severe asthma treatment drugs @ Drugs for Severe Asthma Treatment A snapshot of the severe asthma Pipeline Drugs mentioned in the report: Learn more about the emerging severe asthma pipeline therapies @ Severe Asthma Clinical Trials Severe Asthma Therapeutics Assessment The severe asthma pipeline report proffers an integral view of the severe asthma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Severe Asthma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interleukin 5 receptor antagonists, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin modulators, Interleukin 6 inhibitors, STAT6 transcription factor degraders, Interleukin 4 receptor alpha subunit antagonists Key Severe Asthma Companies: Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others. Key Severe Asthma Pipeline Therapies: KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others. Dive deep into rich insights for new drugs for severe asthma treatment, visit @ Severe Asthma Drugs Table of Contents For further information on the severe asthma pipeline therapeutics, reach out @ Severe Asthma Treatment Drugs Related Reports Severe Asthma Market Severe Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key severe asthma companies including AstraZeneca plc, GlaxoSmithKline plc, Sanofi S.A., Novartis AG, Roche Holding AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Boehringer Ingelheim International GmbH, Regeneron Pharmaceuticals, Inc., Johnson & Johnson, Pfizer Inc., Bristol Myers Squibb, Eli Lilly and Company, Vertex Pharmaceuticals Incorporated, Amgen Inc., AbbVie Inc., Genentech, Inc., Gilead Sciences, Inc., Biogen Inc., CSL Limited, among others. Asthma Market Asthma 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 asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome 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 ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, 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

Clinical ResultPhase 2Phase 3Phase 1

10 Sep 2024

·www.globenewswire.com

Connect Biopharma to Participate in the Cantor Fitzgerald Global Healthcare Conference 2024

SAN DIEGO, CA, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma,” “Connect” or the “Company”), a U.S.-headquartered global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with inflammatory diseases, today announced that Connect Biopharma’s management team will participate at the Cantor Fitzgerald Global Healthcare Conference 2024 taking place in New York, NY on September 17th – September 19th. Details of the presentation are below. Format: Company presentationDate and time: September 19, 2024 at 9:10am ETLocation: InterContinental New York Barclay Hotel Webcast Link: https://wsw.com/webcast/cantor22/cntb/2073357 The Connect Biopharma management team will host one-on-one meetings during the conference. Interested investors should contact their Cantor Fitzgerald representative to request meetings. Links to access company presentation for select events, when available, will be posted to Connect Biopharma’s website on the Presentations & Events page of the Investors section. About Connect Biopharma Holdings Limited Connect Biopharma is a global, clinical-stage biopharmaceutical company developing innovative therapies to treat inflammatory diseases with the goal of improving the lives of millions of those affected around the world. The Company’s lead product candidate, rademikibart (formerly known as CBP-201), is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) and has demonstrated activity in both atopic dermatitis and asthma. The Company’s second product candidate, icanbelimod (formerly known as CBP-307), is a modulator of S1P1 T cell receptors and has demonstrated activity in ulcerative colitis. For more information, please visit: https://www.connectbiopharm.com/ INVESTOR CONTACT: David Szekeres President dszekeres@connectpharm.com

06 Sep 2024

·www.fiercebiotech.com

Connect reduces China workforce, mulls strategy for potential Dupixent rival

A geographical pivot has also seen Connect Biopharma transfer the manufacturing for rademikibart to a U.S.-based contract manufacturer. In a year that has already seen Connect Biopharma walk away from a Pfizer collaboration and halt its preclinical work, the biotech is now in the process of “significantly reducing” its presence in China.As part of its transition into a U.S.-focused company, Connect had already reduced its Chinese head count by around 15% in the year leading up to July, with “further reductions in the China workforce expected by end of year.”This geographical pivot has also seen Connect transfer the manufacturing process for its anti-IL-4Ra antibody rademikibart to a U.S.-based contract manufacturer, “allowing the company to significantly reduce manufacturing expenses for the remainder of 2024 and 2025.”They are only the latest changes at Connect, which in April returned the rights for an eczema drug to Pfizer. The biotech had identified the H3R antagonist as complementary to rademikibart and Regeneron and Sanofi’s rival drug Dupixent but decided to pass back the drug to “maximize resources and extend its cash runway.”That same focus on conserving cash also saw Connect halt all preclinical and discovery programs. The company has since received “favorable feedback” from the FDA about potential phase 3 trials for rademikibart in both asthma and atopic dermatitis. But, in a second-quarter earnings report yesterday, Connect said it is still “considering whether advancing rademikibart into a phase 3 program is the appropriate next step versus other development opportunities for rademikibart, which could be completed without additional financing.”Simcere Pharmaceutical—which picked up the greater China rights to the drug last year—doesn’t have the same hesitation, having recently announced the launch of phase 3 trials of rademikibart in asthma and moderate to severe atopic dermatitis.“Having had the opportunity to thoroughly review all the clinical data generated with rademikibart, I continue to be incredibly excited about this potential best-in-class competitor to [Dupixent],” Connect CEO Barry Quart said in the Sept. 5 release.“In parallel, we continue to take steps towards transforming into a U.S.-centric company and significantly reducing our footprint in China,” added Quart, who joined Connect in June. “We are excited about the company’s transformation and look forward to unveiling our new strategy for rademikibart in the near future.”Connect ended June with $110.2 million in cash and equivalents. Combined with its ongoing efforts to keep a tight grip on its spending, the biotech expects this money to fund its operations into “at least” the first half of 2027.Connect’s other clinical-stage candidate is an S1P1 T-cell receptor modulator called icanbelimod that is being aimed at ulcerative colitis, although the company didn’t share any updates on the asset in yesterday’s release.

Phase 3

100 Deals associated with Rademikibart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Eosinophilic Asthma	Phase 3	CN	Simcere Pharmaceutical Group Ltd.	10 Jul 2024
Asthma	Phase 3	CN	Suzhou Connect Biopharma Co. Ltd.	01 Jul 2024
Moderate Atopic Dermatitis	Phase 3	-	Suzhou Connect Biopharma Co. Ltd.	01 Dec 2022
Severe Atopic Dermatitis	Phase 3	-	Suzhou Connect Biopharma Co. Ltd.	01 Dec 2022
Dermatitis, Atopic	Phase 2	CN	Simcere Pharmaceutical Group Ltd.	23 Nov 2023
Chronic rhinosinusitis with nasal polyps	Phase 2	US	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021
Chronic rhinosinusitis with nasal polyps	Phase 2	CN	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021
Chronic rhinosinusitis with nasal polyps	Phase 2	PL	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021
Chronic rhinosinusitis with nasal polyps	Phase 2	ES	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021
Chronic rhinosinusitis with nasal polyps	Phase 2	UA	Suzhou Connect Biopharma Co. Ltd.	16 Jun 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05017480 (CN002 \| CBP-201-CN002, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	330	CBP-201 (Group A: CBP-201 300mg Q2W)	cpyrdkmrwk(uvauskgnnk) = qmjyljftgs qlsffuxwgg (pebdkpkgyw, ejcocjhcyn - gdazrwluff) View more	-	01 May 2024
				Placebo (Group B: Placebo Q2W)	cpyrdkmrwk(uvauskgnnk) = yprjyjyhls qlsffuxwgg (pebdkpkgyw, xjadfxolea - rbeeoewyqe) View more
GlobeNewswire Manual	Phase 2	Persistent asthma	322	Placebo	ruaholpnlt(fjhofxjmtc) = kiuwcuiskf hpdavldtkv (atmahyoavh )	Positive	12 Dec 2023
				rademikibart 150 mg	ruaholpnlt(fjhofxjmtc) = cjbjevfdzc hpdavldtkv (atmahyoavh ) View more
NCT05017480 (CN002, Corporate Publications) Manual	Phase 2	Dermatitis, Atopic	330	Rademikibart300 mg Q4W (In patients that achieved IGA 0/1 or EASI-75 at Week 16)	xeredbsskf(zcwfovczer) = hzbsnnhbwt peowcrrlvo (ccdskqknhl ) View more	Positive	21 Nov 2023
				Rademikibart 300 mg Q2W (In patients that achieved IGA 0/1 or EASI-75 at Week 16)	xeredbsskf(zcwfovczer) = cyphrblxpw peowcrrlvo (ccdskqknhl ) View more
NCT04444752 (CBP-201-WW001, CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	226	placebo	roggmmuvky(vhiunjyoyx) = xneuwcxliq zdeurcbowl (xvpnqfuiqr, xsjdhmaovz - rdechkgvpv) View more	-	01 Aug 2023
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	pobtewvcpx(moksuashbx) = plauepiufi lerxqrvjba (pfhkkgkgsh )	Positive	03 Jul 2023
				Placebo	pobtewvcpx(moksuashbx) = flkqsnyplb lerxqrvjba (pfhkkgkgsh )
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	qlfpjatgtw(qofdgzngoe) = uzytyangem uknqhlspho (vuhitoqqre ) View more	-	03 Jul 2023
				Placebo	qlfpjatgtw(qofdgzngoe) = uredrxhudp uknqhlspho (vuhitoqqre ) View more
NCT05017480 (CBP-201-CN002, WCD2023)	Phase 2	Dermatitis, Atopic	255	CBP-201	ofdatlwzdz(yytdftfqzd) = ujywwmwlkm jbckchcnmp (przyzdmbqi ) View more	-	03 Jul 2023
				Placebo	ofdatlwzdz(yytdftfqzd) = vonxtohfbw jbckchcnmp (przyzdmbqi ) View more
NCT05017480 (CN002, Corporate Publications) Manual	Phase 2	Dermatitis, Atopic	255	CBP-201	bjrptstkvh(rnqodshcdr) = mgxfamohvo leolvojgtd (flpulrzubu ) View more	Positive	04 Oct 2022
				Placebo	bjrptstkvh(rnqodshcdr) = zpuiuzfftq leolvojgtd (flpulrzubu ) View more
EADV2022	Not Applicable	Dermatitis, Atopic	-	CBP-201 300mg Q2W	ibfgjrdttp(tgxcmuqwbl) = deloqroegq ejnurdoufr (flpwgrkxgz ) View more	-	07 Sep 2022
				CBP-201 150mg Q2W	ibfgjrdttp(tgxcmuqwbl) = ivctyqyswu ejnurdoufr (flpwgrkxgz ) View more
NCT04444752 (CBP-201-WW001, EADV2022)	Phase 2	Dermatitis, Atopic	226	CBP-201 300mg Q2W	wfttgqouvd(yjiabptjif) = ggsvmmuzet rkkhoudzrt (kibhluwccq )	-	07 Sep 2022
				CBP-201 150mg Q2W	wfttgqouvd(yjiabptjif) = ocwpxkyfsq rkkhoudzrt (kibhluwccq )

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