2024-519795-11-00招募中2 期
APG777-202 - A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
Apogee Therapeutics Inc.10 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2025年8月11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
- 79
- 试验地点
- 10
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events [Time Frame: Up to 3 years]
研究概览
简要总结
To evaluate the long-term safety and tolerability of APG777 in patients with moderate-to-severe AD.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator’s opinion, compliant with the study protocol
- •Participants who, in the Investigator’s opinion, would benefit from long-term treatment with APG777
- •Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study
排除标准
- •Participants who have developed an AE while participating in the Parent Study which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient
- •Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study
- •Use of any of the prohibited medications in the Parent Study through Screening Visit (Visit 1) of the LTE study
- •Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events [Time Frame: Up to 3 years]
Number of Participants with Treatment Emergent Adverse Events [Time Frame: Up to 3 years]
次要结局
- Percentage of Participants who achieve Eczema Area and Severity Index (EASI) 50, 75, 90, and 100 calculated based on Parent Study Baseline [Time Frame: Through Extended Treatment Period, an average of 2 years]
- Percentage of Participants who achieve a validated Investigator Global Assessment Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) and a ≥ 2-point reduction as calculated based on Parent Study Baseline. [Time Frame: Through Extended Treatment Period, an average of 2 years]
- Percentage of Participants who achieve ≥ 4-point improvement in the weekly mean of the daily Itch Numeric Rating Scale (I-NRS) as calculated based on Parent Study Baseline [Time Frame: Through Extended Treatment Period, an average of 2 years]
- Percentage of Participants who use Rescue Therapy [Time Frame: Through Extended Treatment Period, an average of 2 years]
- Percentage of Participants Who Continue to Exhibit EASI 75 Of the participants who achieve EASI 75 at Week 52 of the Parent Study, the percentage that continue to exhibit EASI 75 will be determined [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]
- Percentage of Participants Who Continue to Exhibit vIGA-AD Response Of the participants who achieve vIGA-AD of clear (0) or almost clear (1) and a ≥ 2-Point reduction at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]
- Percentage of Participants Who Continue to Exhibit I-NRS Response Of the participants who achieve a ≥ 4-point improvement in the weekly mean of the daily I NRS at Week 52 of the Parent Study, the percentage that continue to exhibit the response will be determined. [Time Frame: From Week 52 Through Extended Treatment Period, an average of 2 years]
- Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs [Time Frame: Up to 3 years]
- Serum Concentrations of APG777 Over Time [Time Frame: Up to 3 years]
- Predose Serum Concentrations of APG777 [Time Frame: Up to 3 years]
研究者
Study Director
Scientific
Apogee Therapeutics Inc.
研究点 (10)
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