NCT06863961进行中（未招募）2 期
A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
- 试验地点
- 130
- 主要终点
- Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).
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
- Triple (Participant, Care Provider, 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
- •AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening
- •Moderate to severe AD
- •At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study
排除标准
- •Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis
- •IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study
- •Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study
- •Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline
- •Acquired or congenital immunodeficiency
- •Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study
研究组 & 干预措施
Afimkibart Group II
Experimental
Participants will receive afimkibart via SC injection.
干预措施: Afimkibart (Drug)
Afimkibart Group III
Experimental
Participants will receive afimkibart via SC injection.
干预措施: Afimkibart (Drug)
Afimkibart Group I
Experimental
Participants will receive afimkibart via subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Placebo
Placebo Comparator
Participants will receive placebo via SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16
时间窗: Baseline and Week 16
次要结局
- Percentage of EASI-75 Responders at Week 16(At Week 16)
- Percentage of Participants with Adverse Events(Baseline up to end of study (approximately 1 year))
- Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32(At Week 16 and Week 32)
- Percentage of Participants who Achieve EASI-75 Response at Week 32(At Week 32)
- Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32(At Week 16 and Week 32)
- Percent Change from Baseline in EASI by Visit(Baseline up to end of study (approximately 1 year))
- Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit(Baseline up to end of study (approximately 1 year))
- Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit(Baseline, weeks 4, 10, 16, 22 and 32)
- Percentage of EASI-75 Responders at Week 16(At Week 16)
- Percentage of Participants with Adverse Events(Baseline up to end of study (approximately 1 year))
- Serum Concentration of Afimkibart at Specified Timepoints(Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.)
研究者
研究点 (130)
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