NCT07223697招募中2 期
An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 29
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study
- •Parent Clinical Trial-Specific Criteria:
- •Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved => EASI50 response from study baseline
排除标准
- •Evidence of other skin conditions that would interfere with the assessment of AD
- •Withdrawal of consent and/or premature discontinuation from parent study
- •Any permanent discontinuation of study drug in parent study
- •History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart
研究组 & 干预措施
Afimkibart Group I
Experimental
Participants will receive Afimkibart as subcutaneous (SC) injection.
干预措施: Afimkibart (Drug)
Afimkibart Group II
Experimental
Participants will receive Afimkibart as SC injection.
干预措施: Afimkibart (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: From Baseline up to 6 years
次要结局
- Change From Baseline (in Parent Study) in Eczema Area and Severity Index (EASI) Score at Each Visit(Baseline, Up to 6 years)
- Percent Change From Baseline (in Parent Study) in EASI Score at Each Visit(Baseline, Up to 6 years)
- Percentage of Participants With EASI-50 at Each Visit(Up to 6 years)
- Percentage of Participants with EASI-75 at Each Visit(Up to 6 years)
- Percentage of Participants with EASI-90 at Each Visit(Up to 6 years)
- Percentage of Participants who Achieve Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of Clear (0) or Almost clear (1) at Each Visit(From Baseline up to 6 years)
- Change from Baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at Each Visit(Baseline, Up to 6 years)
- Change from Baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at Each Visit(Baseline, Up to 6 years)
- Serum Concentration of Afimkibart at Specified Timepoints(Pre-dose on Day 1, Weeks 2, 10, 18, 26, 34, 42, 50 74, 98, 122, 146, 170, 194, 218, 242, 266, 290 and 14 weeks after last dose)
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to Afimkibart(From Baseline up to 6 years)
- Percentage of Participants with Neutralizing Antibody (NAb) to Afimkibart(From Baseline up to 6 years)
研究者
研究点 (29)
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