2023-503327-26-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults with Active Sjögren’s Syndrome (POETYK SjS-1)
Bristol-Myers Squibb Services Unlimited Company55 个研究点 分布在 13 个国家目标入组 243 人开始时间: 2023年12月5日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 243
- 试验地点
- 55
- 主要终点
- Change from baseline in ESSDAI at Week 52
研究概览
简要总结
To compare the efficacy of deucravacitinib versus placebo in participants with active SjS by ESSDAI improvement at Week 52
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Eligible participants will include adults (≥ 18 years old or local age of majority) who satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS, have moderate to severe SjS (ESSDAI ≥ 5), and be positive for anti-SSA/Ro antibody. Other eligibility criteria will include short duration of disease (≤ 10 years) and a SWSF ≥ 0.05 mL/minute
排除标准
- •Participants with the following diagnoses are excluded: autoimmune disease other than SjS (e.g. rheumatoid arthritis, SLE, systemic sclerosis), active fibromyalgia, medical condition(s) associated with sicca syndrome, severe complications of SjS (vasculitis, lymphoma, active central nervous system or peripheral nervous system involvement, severe renal/pulmonary/muscular involvement). Participants with prior exposure to deucravacitinib or TYK2 inhibitor, prior exposure to biological therapy within washout period or receiving therapy for active or chronic infection are also excluded.
结局指标
主要结局
Change from baseline in ESSDAI at Week 52
Change from baseline in ESSDAI at Week 52
次要结局
- Change from baseline in ESSPRI at Week 52
- Change from baseline in FACIT-Fatigue at Week 52
- Proportion of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
- Proportion of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
- Proportion of participants with ESSDAI < 5 at Week 52
- Change from baseline in ESSDAI at Week 24
- Change from baseline in SWSF at Week 52
- Change from baseline in PhGA at Week 52
- Change from baseline in ocular dryness NRS at Week 52
- Change from baseline in oral dryness NRS at Week 52
- Change from baseline in joint/muscle pain NRS at Week 52
- Incidence of AEs, SAEs, AEs leading to discontinuation of treatment and study discontinuation, and target AEIs; change in laboratory, ECG, and vital signs; and abnormalities in laboratory, ECG, and vital signs
- Proportion of participants with increase of Schirmer's test ≥ 5 mm if abnormal baseline or No change of Schirmer's test to abnormal if normal baseline at Week 52
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (55)
Loading locations...
相似试验
招募中
3 期
Efficacy and Safety of Deucravacitinib Compared with Placebo in
Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic
Disease-modifying Anti-rheumatic Drugs2023-506256-25-00Bristol Myers Squibb International Corporation326
招募中
2 期
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety deucravacitinib in patients with chronic hand eczema (investigator-sponsored research)2023-504298-19-00Charite Universitaetsmedizin Berlin KöR57
招募中
3 期
Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer
Study of osimertinib administered after radiation therapy in patients with early stage non-small cell lung cancer harboring an EGFR mutation2024-512667-31-00AstraZeneca AB148
招募中
2 期
DEUCRALIPLichen planus2022-502991-21-00Rheinische Friedrich Wilhelms Universitaet Bonn30
招募中
2 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants with Moderate to Severe Atopic Dermatitis2024-517814-13-00Janssen Cilag International86