A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) When Used In Combination With Topical Corticosteroid Treatment (TCS) in Participants With Moderate to Severe Atopic Dermatitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 417
- 试验地点
- 6
- 主要终点
- Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ages 18 to 75 years old when signing the informed consent.
- •AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
- •Moderate to Severe Atopic Dermatitis.
- •Recent history of inadequate response to treatment with topical medications.
排除标准
- •Participation in a prior 611 clinical study.
- •Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months.
- •Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study.
- •Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study.
- •Evidence of active acute or chronic hepatitis.
- •History of malignancy within 5 years before the screening visit or currently.
- •Pregnant or breastfeeding women, or women planning to become pregnant.
- •Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
研究组 & 干预措施
Placebo+Topical Corticosteroid
Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
干预措施: Topical corticosteroid (Drug)
611 interval 1+Topical Corticosteroid
Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
干预措施: 611 (Drug)
611 interval 1+Topical Corticosteroid
Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
干预措施: Topical corticosteroid (Drug)
611 interval 2+Topical Corticosteroid
Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
干预措施: Topical corticosteroid (Drug)
Placebo+Topical Corticosteroid
Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
干预措施: Placebo (Drug)
611 interval 2+Topical Corticosteroid
Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
干预措施: 611 (Drug)
结局指标
主要结局
Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.
时间窗: Baseline to Week 16
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)
时间窗: Baseline to Week 16
次要结局
- Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16(Baseline to Week 16)