2024-511260-84-00招募中2 期
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
Apogee Therapeutics Inc.45 个研究点 分布在 6 个国家目标入组 154 人开始时间: 2024年8月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 45
- 主要终点
- Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16
研究概览
简要总结
Part A: To evaluate the effectiveness of APG777 compared to placebo in patients with moderate-to-severe AD after 16 weeks of treatment. Part B: To evaluate three different doses of APG777 compared to placebo in patients with moderate-to-severe AD after 16 weeks of treatment.
研究设计
- 分配方式
- Randomized
- 主要目的
- Part B
- 盲法
- Double (Subject, Investigator, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 APG777
- •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
结局指标
主要结局
Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16
Part A: Percent Change from Baseline in Eczema Area and Severity Index (EASI) [Time Frame: Baseline and at Week 16] Part B: Proportion of patients who achieve EASI 75 at Week 16
次要结局
- Part A and B: Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to 106 Weeks]
- Change from Baseline in EASI [Time Frame: Baseline, through Week 16 and at Week 52]
- Percent Change from Baseline in EASI [Time Frame: Baseline through Week 16 and at Week 52]
- Proportion of Participants Achieving EASI 50, 75, 90, and 100 Score [Time Frame: Baseline through Week 16 and at Week 52]
- Proportion of Participants Achieving a Validated Investigator Global Assessment (vIGA-AD) Score of 0 (clear) or 1 (almost clear) and a >=2-Point Reduction [Time Frame: Baseline through Week 16 and at Week 52]
- Change from Baseline in BSA Involvement [Time Frame: Baseline through Week 16 and at Week 52]
- Proportion of Participants Achieving a >=4 Point Improvement in the Weekly Mean of the Daily Itch Numeric Rating Scale (I-NRS) [Time Frame: Baseline through Week 16 and at Week 52]
- Percent Change from Baseline in the Weekly Mean of the Daily I-NRS [Time Frame: Baseline through Week 16 and at Week 52]
- Serum Concentrations of APG777 Over Time [Time Frame: Up to 106 Weeks]
- Predose Serum Concentrations of APG777 (Ctrough) [Time Frame: Up to 106 Weeks]
- Maximum concentration (Cmax) of APG777 [Time Frame: Up to 106 Weeks]
- Time to reach Cmax (tmax) [Time Frame: Up to 106 Weeks]
- Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUC0-t) in the Induction Period [Time Frame: Baseline to 16 Weeks]
- AUC Over the Dosing Interval (AUC0-tau) in the Maintenance Period [Time Frame: 16 Weeks to 52 Weeks]
研究者
Study Director
Scientific
Apogee Therapeutics Inc.
研究点 (45)
Loading locations...
相似试验
招募中
2 期
A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mass (ARTEMIS)Postmenopausal Osteoporosis2024-515610-41-00Angitia Inc. Ltd.260
招募中
2 期
A Study to Evaluate the Long-term Safety and Effectiveness of APG777 in Subjects with Atopic DermatitisAtopic Dermatitis2024-519795-11-00Apogee Therapeutics Inc.79
进行中（未招募）
2 期
Taldefgrobep Alfa in Adults With Overweight and ObesityObesityNCT07281495Biohaven Therapeutics Ltd.150
招募中
3 期
A Clinical Study that will measure how well SEP-363856 works and how safe it is in adults with Generalized Anxiety Disorder2022-502077-42-00Otsuka Pharmaceutical Development & Commercialization Inc.255
招募中
2 期
A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis2022-501119-14-01Gilead Sciences Inc.78