A Phase 1b, Open-label, Randomized, Multicenter, Active Comparator Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Combination of APG777 + APG990 in Adults With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 86
- 试验地点
- 20
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).
详细描述
Participants will be randomized to APG777 + APG990 or dupilumab in a 1:1 ratio. Randomization will be stratified on Day 1 according to Baseline disease severity and geographic region.
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
- None
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 and as determined by the Investigator through participant interview and/or review of the medical history.
- •Moderate-to-severe AD at Screening and Baseline (Day 1) visits, defined as: a) Eczema Area and Severity Index (EASI) score of ≥ 16, b) vIGA-AD score of ≥ 3, and c) AD affecting ≥10% of body surface area (BSA).
- •History of inadequate response to treatment with topical medications
- •Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 1) visit.
排除标准
- •Participation in a prior study with APG777 or 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
- •History of known hypersensitivity to any of the ingredients in APG777, APG990, or dupilumab.
- •Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments
- •Note: Additional protocol defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
APG777 + APG990
Participants will receive protocol specified combination dose of APG777 + APG990
干预措施: APG777 (Drug)
APG777 + APG990
Participants will receive protocol specified combination dose of APG777 + APG990
干预措施: APG990 (Drug)
Dupilumab
Participants will receive protocol specified dose of Dupilumab
干预措施: Dupilumab (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 24 weeks
次要结局
- Predose Serum Concentrations (Ctrough) of APG777(Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24)
- Predose Serum Concentrations (Ctrough) of APG990(Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24)
- Maximum Serum Concentrations (Cmax) of APG777(Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24)
- Maximum Serum Concentrations (Cmax) of APG990(Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24)
- Time to Reach Cmax (tmax) of APG777(Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24)
- Time to Reach Cmax (tmax) of APG990(Baseline, Week 1, 2, 4, 8, 12, 16, 20, 24)