A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 72
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events
研究概览
简要总结
This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).
The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.
This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 —（Adult, Older Adult）
- 性别
- All
- 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 from 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
- •Note: Additional protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
APG777 - Long Term Extension Treatment - 24 Weeks
Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
干预措施: APG777 (Drug)
APG777 - Long Term Extension Treatment - 12 Weeks
Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201).
干预措施: APG777 (Drug)
APG777 - Open Label Escape Arm
Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen.
干预措施: APG777 (Drug)
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events
时间窗: 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(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.(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(Through Extended Treatment Period, an average of 2 years)
- Percentage of Participants who use Rescue Therapy(Through Extended Treatment Period, an average of 2 years)
- Percentage of Participants Who Continue to Exhibit EASI 75(From Week 52 up to Through Extended Treatment Period, an average of 2 years)
- Percentage of Participants Who Continue to Exhibit vIGA-AD Response(From Week 52 up to Through Extended Treatment Period, an average of 2 years)
- Percentage of Participants Who Continue to Exhibit I-NRS Response(From Week 52 up to Through Extended Treatment Period, an average of 2 years)
- Number of Participants who Discontinued Treatment Due to Treatment-Related TEAEs and SAEs(Up to 3 years)
- Serum Concentrations of APG777 Over Time(Up to 3 years)
- Predose Serum Concentrations of APG777(Up to 3 years)