A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 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
- 113
- 试验地点
- 30
- 主要终点
- Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12
研究概览
简要总结
To assess the efficacy and safety of MEDI9929 in adult subjects with Atopic Dermatitis
详细描述
This is a Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of MEDI9929 administered subcutaneously to adult subjects with moderate to severe Atopic Dermatitis. Subjects will be randomized in a 1:1 fashion and will be stratified at screening. Approximately 100 subjects are planned to be randomized at approximately 35 sites in 6 countries
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
- •AD meeting Hanifin and Rajka criteria
- •Age 18-75 years inclusive at screening
- •Atopic dermatitis that affects greater than/equal to 10% body surface area
- •Moderate to severe AD
- •Effective birth control in line with protocol details
排除标准
- •Active dermatologic conditions which may confuse the diagnosis of Atopic Dermatitis
- •Hepatitis B, C or HIV
- •Pregnant or breastfeeding
- •History of anaphylaxis following any biologic therapy
- •History of clinically significant infections within 4 weeks prior to Visit 3
- •Diagnosis of helminth parasitic infection within 6 months to screening
- •History of Cancer except basal cell
- •Receipt of any marketed or investigational biologic agent within 4 months to visit 3
- •Any clinically relevant abnormal finding
- •Major surgery within 8 weeks prior to Visit 1
研究组 & 干预措施
Placebo
Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
干预措施: Placebo (Biological)
MEDI9929 280 mg
Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
干预措施: MEDI9929 (Biological)
结局指标
主要结局
Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12
时间窗: Baseline (Day 1) and Week 12
The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 \[none\] to 3 \[severe\]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.
次要结局
- Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12(Baseline (Day 1) and Week 12)
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline(Baseline (Day 1) and Week 12)
- Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12(Baseline (Day 1) and Week 12)
- Mean Change From Baseline in EASI Total Score at Week 12(Baseline (Day 1) and Week 12)
- Mean Trough Serum Concentration of MEDI9929(Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose))
- Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies(Baseline (Day 1) to Week 22)
- Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75(Baseline (Day 1) and Week 12)
- Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12(Baseline (Day 1) and Week 12)
- Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50(Baseline (Day 1) and Week 12)
- Mean Change From Baseline in 5-D Pruritus Score at Week 12(Baseline (Day 1) and Week 12)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)(From treatment administration (Day1) to 22 weeks)