A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Subjects With Ichthyosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 7
- 主要终点
- Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16
研究概览
简要总结
Efficacy and Safety of imsidolimab in Participants with Ichthyosis
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of imsidolimab compared with placebo in adolescent and adult participants with ichthyosis. This study will also characterize the pharmacokinetic (PK) profile of imsidolimab and explore the immune response to imsidolimab in participants with ichthyosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Ichthyosis
- •IASI total score ≥ 18, erythema score ≥ 2
- •Participant has been using emollient daily for at least 1 week prior to Day 1 and agrees to continue using that same emollient daily at the same frequency throughout the study
排除标准
- •A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis will be excluded.
研究组 & 干预措施
Imsidolimab
Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
干预措施: Imsidolimab (Drug)
Placebo
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection.
干预措施: placebo (Biological)
结局指标
主要结局
Change From Baseline in Ichthyosis Area Severity Index (IASI) Total Score at Week 16
时间窗: Baseline and Week 16
IASI quantified the severity of participants ichthyosis based on severity of erythema/scaling \& percentage of body surface area (BSA) affected. Degree of erythema \& scaling scored from 0 (none) to 4 (very severe) for each of 4 body regions (BR) \[A1: head \& neck (H\&N), A2: upper limbs (UL), A3: trunk (T), A4: lower limbs (LL)\]. Percentage of BSA involved for each BR (B1: % in H\&N, B2: % in UL, B3: % in T, B4: % in LL). Percentage involvement was assigned numerical value(0= 0, 1%-9%= 1, 10%-29%= 2, 30%-49%= 3, 50%-69%= 4, 70%-89%= 5, 90%-100%= 6).Total extent was determined using multiplier considering % of total BSA by each BR (C1= 0.1 for H\&N; C2= 0.2 for UL; C3= 0.3 for T; C4= 0.4 for LL). IASI-Erythema (E)= A1E x B1 x C1 + A2E x B2 x C2 + A3E x B3 x C3 + A4E x B4 x C4 (score 0 to 24) IASI-Scaling (S)= A1S x B1 X C1 + A2S x B2 x C2 + A3S x B3 x C3 + A4S x B4 x C4 (score 0 to 24) IASI total score= IASI-E + IASI-S score ranged from 0 - 48, higher score indicated worse disease state.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From first dose up to study termination (maximum up to 9.4 weeks))
- Change From Baseline in IASI-E Scores at Week 16(Baseline and Week 16)
- Percent Change From Baseline in IASI-S Scores at Week 16(Baseline and Week 16)
- Percent Change From Baseline in IASI Total Score at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving an Improvement of 50% From Baseline in IASI (IASI50) at Week 16(Week 16)
- Change From Baseline in IASI-S Scores at Week 16(Baseline and Week 16)
- Percent Change From Baseline in IASI-E Scores at Week 16(Baseline and Week 16)