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
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 166
- 主要终点
- Proportion of participants who maintain ACR20 response at Week 28
研究概览
简要总结
This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).
详细描述
The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at Week 28.
The total duration of study participation is expected to be up to 86 weeks for an individual participant with 16 weeks of open-label treatment, 12 weeks of blinded randomized treatment, and 48 weeks of optional long-term extension treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female participants of age >18 years will be enrolled.
- •Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance of Associations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
- •Greater than or equal to 6/68 in tender joint count (TJC) and ≥ 6/66 swollen joint count (SJC) at both Screening and Baseline visits.
- •C-reactive protein ≥ upper limit of normal (ULN) at Screening Visit.
- •Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
- •Inadequate response to at least 2 classes of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs).
- •Additional inclusion criteria are defined in the protocol.
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 nonimmunosuppressive fragment crystallizable (Fc)-based therapeutic protein (e.g., monoclonal antibody [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.
- •Other, more specific exclusion criteria are defined in the protocol.
研究组 & 干预措施
IMVT-1402 Dose 1
干预措施: IMVT-1402 (Drug)
IMVT-1402 Dose 2
干预措施: IMVT-1402 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants who maintain ACR20 response at Week 28
时间窗: Week 28
次要结局
- Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28(Week 16 to Week 28)
- Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28(Week 16 to Week 28)