A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 65
- 主要终点
- Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.
详细描述
This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).
Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and geographic region (Japan versus rest of world).
At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
- •a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
- •moderate to severe AD at the Baseline Visit
- •history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments
排除标准
- •prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
- •concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments
研究组 & 干预措施
Risankizumab 150 mg
Participants randomized to receive risankizumab 150 mg for 16 weeks in Period A followed by risankizumab 150 mg for 36 weeks in Period B.
干预措施: Risankizumab (Biological)
Placebo
Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B.
干预措施: Risankizumab (Biological)
Placebo
Participants randomized to receive placebo for 16 weeks in Period A followed by either risankizumab 150 mg or risankizumab 300 mg for 36 weeks in Period B.
干预措施: Placebo (Biological)
Risankizumab 300 mg
Participants randomized to receive risankizumab 300 mg for 16 weeks in Period A followed by risankizumab 300 mg for 36 weeks in Period B.
干预措施: Risankizumab (Biological)
结局指标
主要结局
Percentage of Participants Achieving At Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI 75) at Week 16
时间窗: Baseline and Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
次要结局
- Percentage of Participants Who Achieved a SCORAD 50 Response at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved a SCORAD 75 Response at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved a Reduction of ≥ 4 Points in Worst Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline and Week 16)
- Percent Change From Baseline in EASI Score at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved an EASI 90 Response at Week 16(Baseline, Week 16)
- Change From Baseline in Percentage of BSA Affected by Atopic Dermatitis at Weeks 28 and 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved a Children's Dermatology Life Quality Index (CDLQI) Score of "0" or "1" at Week 16(Week 16)
- Change From Baseline in DLQI Score at Week 16(Baseline and Week 16)
- Percent Change From Baseline in EASI Score at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved an EASI 75 Response at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved an EASI 50 Response at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved a vIGA-AD Score of "0" or "1" With a Reduction From Baseline of ≥ 2 Points at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of "0" or "1" at Week 16(Week 16)
- Percentage of Participants Who Achieved a CDLQI Score of "0" or "1" at Week 28 and Week 52(Weeks 28 and 52)
- Percentage of Participants Who Achieved an EASI 50 Response at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved an EASI 90 Response at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Change From Baseline in Percentage of Body Surface Area (BSA) Affected by Atopic Dermatitis at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved a 50% Improvement in SCORing Atopic Dermatitis (SCORAD) Score (SCORAD 50) at Week 16(Baseline, Week 16)
- Percentage of Participants Who Achieved a SCORAD 75 Response at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 16 Among Those With a DLQI ≥ 4 at Baseline(Baseline and Week 16)
- Percentage of Participants Who Achieved a Reduction in DLQI of ≥ 4 Points From Baseline at Week 28 and Week 52 Among Those With a DLQI ≥ 4 at Baseline(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved a SCORAD 90 Response at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved a SCORAD 90 Response at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Percentage of Participants Who Achieved a DLQI Score of "0" or "1" at Week 28 and Week 52(Weeks 28 and 52)
- Change From Baseline in CDLQI Score at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Change From Baseline in DLQI Score at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Change From Baseline in CDLQI Score at Week 16(Baseline and Week 16)
- Change From Baseline in Worst Pruritus Numerical Rating Scale at Week 16(Baseline and Week 16)
- Percentage of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52(Baseline and Weeks 28 and 52)
- Change From Baseline in Worst Pruritus NRS Score at Week 28 and Week 52(Baseline and Weeks 28 and 52)