A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ISB 830 in Adult Subjects With Moderate to Severe Atopic Dermatitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 462
- 试验地点
- 83
- 主要终点
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16
研究概览
简要总结
Phase 2b, randomized, double-blinded, placebo-controlled dose range finding study to evaluate the efficacy, safety and tolerability of ISB 830 in adults with moderate to severe atopic dermatitis. The study will be conducted in 2 Parts, with dosing Groups 1-4 comprising Part 1, and dosing Groups 5-6 comprising Part 2. All subjects will receive open-label ISB 830 after a 16 week blinded treatment period.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥18 years with physician diagnosis of atopic dermatitis for >1 year as defined by American Academy of Dermatology Consensus Criteria.
- •Atopic dermatitis involvement of ≥10% of body surface area at screening and baseline.
- •EASI score of ≥12 at screening or ≥16 at baseline.
- •IGA score of ≥3 at screening and baseline (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe)
- •Baseline Pruritus Numerical Rating Scale (NRS) score for maximum itch intensity ≥3 over the previous 24 hours.
排除标准
- •Pregnant or lactating women.
- •Prior treatment with ISB 830
- •Treatment with biologics
- •Systemic corticosteroids, immunosuppressive/immunomodulatory drugs or phototherapy within 4 weeks of baseline
- •Active chronic or acute infection requiring systemic treatment
研究组 & 干预措施
ISB 830 - Part 1 Group 1
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
干预措施: ISB 830 - Part 1 Group 1 (Drug)
ISB 830 - Part 1 Group 2
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
干预措施: ISB 830 - Part 1 Group 2 (Drug)
ISB 830 - Part 1 Group 3
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830 or placebo.
干预措施: ISB 830 - Part 1 Group 3 (Drug)
Placebo - Part 1 Group 4
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
干预措施: Placebo - Part 1 Group 4 (Drug)
ISB 830 - Part 2 Group 5
Subcutaneous (SC) administration of ISB 830 as a loading dose, followed by SC maintenance dose of ISB 830.
干预措施: ISB 830 - Part 2 Group 5 (Drug)
Placebo - Part 2 Group 6
Subcutaneous (SC) administration of placebo, followed by SC maintenance dose of placebo.
干预措施: Placebo - Part 2 Group 6 (Drug)
结局指标
主要结局
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Clinical Score at Week 16
时间窗: Baseline, Week 16
In EASI, four disease characteristics of atopic dermatitis (AD) (erythema, edema/papulation, excoriation, and lichenification) are assessed for severity on a scale of 0 (absent), 1 (mild), 2 (moderate), 3 (severe). The scores are added up for each of the four body regions (Head and neck, trunk, arms, and legs). The assigned percentages of body surface area (BSA) for each section of the body are 10% for head and neck, 20% for arms, 30% for trunk, and 40% for legs. Each subtotal score is multiplied by the BSA represented by that region. In addition, an area score of 0 to 6 is assigned for each body region, depending on the percentage of AD-affected skin in that area: 0 (none), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Each of the body area scores are multiplied by the area affected. The resulting EASI score ranges from 0 to 72 points, with the highest score indicating worse severity of AD.
次要结局
- Change From Baseline in Global Individual Signs Score (GISS) at Week 16(Baseline, Week 16)
- Percentage Change From Baseline in PGA of Disease and Treatment at Week 16(Baseline, Week 16)
- Percent Change From Baseline in SCORAD Score at Week 16(Baseline, Week 16)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Subscale Scores at Week 16(Baseline, Week 16)
- Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 16(Baseline, Week 16)
- Change From Baseline in Patient Global Assessment (PGA) of Disease and Treatment at Week 16(Baseline, Week 16)
- Percentage of Participants With Improvement (Reduction) in Pruritus Numerical Rating Scale (NRS) Score of ≥ 4 From Baseline at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving a 50% Reduction From Baseline in EASI Score (EASI-50) at Week 16(Baseline, Week 16)
- Percentage of Participants Achieving Both Investigator's Global Assessment (IGA) Clinical Score of 0 or 1 and an IGA Reduction From Baseline of ≥ 2 Points at Week 16(Baseline, Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Baseline, Week 16)
- Percentage of Participants With Anti-Drug Antibody (ADA) at Week 16(Baseline through Week 16)
- Maximum Observed Serum Concentration (Cmax) of ISB 830(Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), 4, 24, 96, 120, and 168 hours postdose on Day 85)
- Area Under Curve From Time Zero to the End of Dosing Interval (AUC0-tau)(Predose (within 15 minutes prior to dose), 4, 24, 96, 120, 168, and 336 hours postdose on Day 1 and predose (within 15 minutes prior to dose), and at 4, 24, 96, 120, 168 hours postdose on Day 85)
- Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score (EASI-75) at Week 16(Baseline, Week 16)
- Number of Missed Work or School Days at Week 16(Week 16)