A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) With or Without Systemic Manifestations
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 156
- 主要终点
- Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
The study will consist of 3 periods:
Period 1: eligible participants will be randomized 1:1 to IMVT-1402 Dose 1 or placebo SC QW for 12 weeks.
Period 2: participants who completed Period 1 will receive IMVT-1402 Dose 1 SC QW for 14 weeks.
Period 3: after completion of Period 2, participants will be re-randomized 1:1 to blinded IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks.
详细描述
The total study duration per participant is approximately 61 weeks.
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
- •Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
- •Have a total CLASI-A score of ≥10 at Screening and Day
- •Participants with a CLASI-A score of ≥8 and <10 are eligible if the score does not include alopecia and/or mucous membrane lesions.
- •Have active CLE despite an adequate trial of conventional therapies.
- •Are positive for at least one autoantibody at Screening.
排除标准
- •Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE.
- •Have rapidly progressive nephritis.
- •Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Period 1: Placebo
Matching placebo for 12 weeks in Period 1
干预措施: Placebo (Drug)
IMVT-1402 Subcutaneous (SC) Once weekly (QW)
- Period 1: IMVT-1402 Dose 1 SC QW for 12 weeks
- Period 2: IMVT-1402 Dose 1 SC QW for 14 weeks
- Period 3: IMVT-1402 Dose 1 or Dose 2 SC QW for 26 weeks
干预措施: IMVT-1402 (Drug)
结局指标
主要结局
Percent change from Period 1 Baseline in Cutaneous Lupus Erythematosus Disease area and Severity Index activity (CLASI-A) score at Week 12
时间窗: Baseline (Day 1) and Week 12
The CLASI-A score represents the overall severity of cutaneous lupus erythematosus (CLE) dermatologic involvement. It is used to assess the activity of mucocutaneous lesions in patients with lupus. The score ranges from 0 (no active lesions) to a maximum of 70. Values between 1 and 9 indicate mild inflammation, 10 to 20 indicate moderate inflammation, and 21 or higher indicate severe inflammation.
次要结局
- Proportion of participants who have a reduction in CLASI-A score of ≥ 5 points from Period 1 Baseline at Week 12(Baseline (Day 1) and Week 12)
- Proportion of participants who have a reduction in CLASI-A score of ≥ 50% from Period 1 Baseline at Week 12(Baseline (Day 1) and Week 12)
- Proportion of participants who have a reduction in CLASI-A score of ≥ 70% from Period 1 Baseline at Week 12(Baseline (Day 1) and Week 12)