2024-515973-82-00招募中2 期
A Phase 2b, Multicenter, Double-blind, Placebo-controlled Randomized Withdrawal Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult-to-Treat, ACPA-Positive Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 37
- 主要终点
- Proportion of participants who achieve ACR20 response at Week 28.
研究概览
简要总结
To evaluate the effects of IMVT-1402 in participants with RA as assessed by American College of Rheumatology 20% (ACR20) Response
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of ‘definite RA’ according to the 2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria
- •Greater than or equal to 6/68 TJC and ≥ 6/66 SJC at both Screening and Baseline visits.
- •C-reactive protein ≥ upper limit of normal (ULN) at screening visit
- •Elevated immunoglobulin G (IgG) + ACPA as the Screening Visit.
- •Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs
排除标准
- •Have received rituximab and experienced insufficient efficacy or loss of efficacy.
- •History of any chronic inflammatory arthritis with onset prior to age 18 or history of acute inflammatory joint disease of different origin from RA
- •Active malignancy or history of malignancy within 5 years prior to screening visit
- •Medical history of primary immunodeficiency, T cell or humoral, including common variable immunodeficiency.
- •Used any nonimmunosuppresive Fc-based therapeutic protein (e.g., mAb or Fc-fusion protein) within 4 weeks prior to or at screening visit.
- •Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or have a documented history of non-response to prior anti-FcRn treatment
结局指标
主要结局
Proportion of participants who achieve ACR20 response at Week 28.
Proportion of participants who achieve ACR20 response at Week 28.
次要结局
- Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28.
- Change in Simplified Disease Activity Index (SDAI) score from week 16 to Week 28
研究者
Immunovant Clinical Trials
Scientific
Immunovant Sciences GmbH
研究点 (37)
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