A Two-part, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of APG777 in Patients With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 470
- 试验地点
- 95
- 主要终点
- Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
研究概览
简要总结
This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A (Proof-of-concept) and Part B (Dose-regimen Finding) will evaluate the safety and efficacy of various induction and maintenance dose regimens of APG777 compared to placebo. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.
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)
盲法说明
The Sponsor's study staff will also be blinded in the study.
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
- •Have a diagnosis of AD that has been present for >=1 year prior to the Screening visit
- •Moderate-to-severe AD at Screening and Baseline visits
- •History of inadequate response to treatment with topical medications, or medical determination that topical therapies are inadvisable
- •Applied a stable dose of non-medicated over-the-counter emollient/moisturizer of their choice on their skin for >=14 days prior to Baseline visit and agrees to continue using the same moisturizer throughout the study except the day of the study visits.
- •Have completed itch questionnaires in the electronic diary for >=4 of 7 days prior to Baseline visit
排除标准
- •Participation in a prior study with APG
- •Prior treatment with protocol-specified monoclonal antibodies (mAbs)
- •Has used any AD-related topical medications within 7 days prior to Baseline visit.
- •Has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect AD within 4 weeks prior to Baseline visit
- •Note: Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part B: Induction Period: APG777
Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen
干预措施: APG777 (Drug)
Part A: Induction Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
干预措施: APG777 (Drug)
Part A: Induction Period: Placebo
Participants will receive matching Placebo injections per protocol defined dosing regimen
干预措施: Placebo (Drug)
Part B: Induction Period: Placebo
Participants will receive matching placebo injections per protocol defined dosing regimen
干预措施: Placebo (Drug)
Part B: Maintenance Period: APG777
Participants will receive APG777 per protocol defined dosing regimen
干预措施: APG777 (Drug)
Part A: Maintenance Period: APG777
Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen
干预措施: APG777 (Drug)
结局指标
主要结局
Part A: Percent Change From Baseline in Eczema Area and Severity Index (EASI)
时间窗: Baseline and at Week 16
Part B: Proportion of participants who achieve EASI 75 at Week 16
时间窗: At Week 16
次要结局
- Part A and B: Percent Change from Baseline in EASI(Baseline through Week 16 and at Week 52)
- Part A and B: Serum Concentrations of APG777 Over Time(Up to 106 Weeks)
- Part A and B: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period(Baseline to 16 Weeks)
- Part A and B: Change from Baseline in EASI(Baseline, through Week 16 and at Week 52)
- Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs)(Up to 106 Weeks)
- Part A and B: Proportion of Participants Achieving a >= 4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS)(Baseline through Week 16 and at Week 52)
- Part A and B: Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >= 2-Point Reduction(Baseline through Week 16 and at Week 52)
- Part A and B: Change from Baseline in Body Surface Area (BSA) Involvement(Baseline through Week 16 and at Week 52)
- Part A and B: Predose Serum Concentrations of APG777 (Ctrough)(Up to 106 Weeks)
- Part A and B: Time to reach Cmax (tmax)(Up to 106 Weeks)
- Part A and B: Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score(Baseline through Week 16 and at Week 52)
- Part A and B: Percent Change from Baseline in the Weekly Mean of the Daily I-NRS(Baseline through Week 16 and at Week 52)
- Part A and B: Maximum concentration (Cmax) of APG777(Up to 106 Weeks)
- Part A and B: AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period(16 Weeks to 52 Weeks)