A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Platform Study to Assess the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 106
- 主要终点
- Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
研究概览
简要总结
This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled Phase II platform study to investigate the efficacy and safety of several interventions in participants with moderate to severe AD.
The first intervention planned to be evaluated is GHZ339. Participants will be randomly assigned to one of the study arms.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •of the master protocol:
- •Able and willing to sign the informed consent (IC)
- •Patients with a diagnosis of AD and onset of disease for at least 1 year
- •Moderate to severe AD
排除标准
- •of the master protocol:
- •Participants with a clinically significant medical condition or infectious disease (specified in sub-protocol)
- •Participants with clinically significant abnormal hematology, clinical chemistry, or urine test results or clinically significant abnormal ECG
- •Participant with any other active inflammatory skin disease
- •Participants with any chronic, uncontrolled medical condition, which would put the participant at increased risk during the study (e.g., uncontrolled: diabetes, hypertension)
- •Participants with any clinically unstable disease states that would likely require systemic corticosteroids (e.g., uncontrolled asthma)
- •Additional inclusion and exclusion criteria may apply depending on the intervention specific requirements
研究组 & 干预措施
GHZ339 Dose A
Participants who will receive GHZ339 at dose A during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
干预措施: GHZ339 (Drug)
GHZ339 Dose B
Participants who will receive GHZ339 at dose B during Treatment Period 1 will receive GHZ339 at dose B during Treatment Period 2
干预措施: GHZ339 (Drug)
GHZ339 Dose C
Participants who will receive GHZ339 at dose C during Treatment Period 1 will receive GHZ339 at dose C or A during Treatment Period 2
干预措施: GHZ339 (Drug)
GHZ339 Dose D
Participants who will receive GHZ339 at dose D during Treatment Period 1 will receive GHZ339 at dose D or A during Treatment Period 2
干预措施: GHZ339 (Drug)
Placebo
Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
干预措施: GHZ339 (Drug)
Placebo
Participants who will receive placebo during Treatment Period 1 will receive GHZ339 at dose A during Treatment Period 2
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
时间窗: Baseline, Week 16
EASI will be used to assess the extend and severity of atopic dermatitis on a scale from 0 to 72 where 72 is worst eczema.
次要结局
- EASI-75 response at Week 16(Baseline, Week 16)
- Investigator Global Assessment (IGA) response at Week 16(Baseline, Week 16)