2025-521745-25-00招募中2 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 14
- 主要终点
- Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
研究概览
简要总结
To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR20 at Week 12.
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
- 否
入选标准
- •Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
- •Has current treatment with oral or parenteral methotrexate (MTX) therapy for ≥12 weeks before Randomization and ≥4 weeks on a stable dose of ≥15 mg/week to ≤25 mg/week (or ≥10 mg/week in participants who are intolerant of MTX at doses ≥12.5 mg/week after complete titration) before Randomization
排除标准
- •Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA
- •Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before randomization
- •Has known infection with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human immunodeficiency Virus (HIV)
- •Has any active infection including but not limited to: A). Symptomatic infection despite adequate treatment (excluding fungal infections of the nail bed or localized oral herpes). B). Chronic infection requiring ongoing antimicrobial treatment. C). Recent infection with completion of parenteral anti-infectives or oral anti-infectives.
- •Has active tuberculosis (TB) or meets TB exclusionary parameters
研究组 & 干预措施
tulisokibart
Experimental
Participants receiving tulisokibart
干预措施: tulisokibart (Drug)
结局指标
主要结局
Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12
次要结局
- Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
- Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
- Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)
- Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12
- Number of Participants Who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Intervention Due to an AE
研究者
Erik Anderson
Scientific
Merck Sharp & Dohme LLC
研究点 (14)
Loading locations...
相似试验
招募中
3 期
C0251006 - A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)2022-502739-20-00Pfizer Inc.77
招募中
3 期
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)Cold UrticariaNCT07266402Celldex Therapeutics240
招募中
3 期
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor DeficiencyNCT07266805Pharvaris Netherlands B.V.32
招募中
2 期
Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes MellitusNCT07282743Sun Pharmaceutical Industries Limited285
招募中
2 期
Topical Ketotifen 0.25% for Secondary VestibulodyniaNCT07257029Center for Vulvovaginal Disorders54