2025-520771-59-00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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 26
- 主要终点
- Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest
研究概览
简要总结
To evaluate the long-term safety and tolerability of afimkibart
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
- 是
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
- •Agreement to adhere to the contraception requirements
- •Completed the treatment period of the parent study
排除标准
- •Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis
- •Withdrawal of consent and/or premature discontinuation from parent study
- •Any permanent discontinuation of study drug in parent study
- •Use of a prohibited therapy during the parent study
- •Investigator determination that treatment discontinuation is in the best interest of the participant
- •History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of afimkibart
结局指标
主要结局
Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest
Incidence and severity of adverse events, serious adverse events, adverse events leading to study treatment discontinuation, adverse events of special interest
次要结局
- Change and percent change from baseline (in parent study) in Eczema Area and Severity Index (EASI) score at each visit
- Proportion of participants with EASI50/75/90 at each visit
- Proportion of participants achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) of clear (0) or almost clear (1) with more than or equal to 2-grade improvement from baseline (in the parent study) at each visit
- Change from parent baseline (in the parent study) in Participant-Oriented Eczema Measure (POEM) at each visit
- Change from parent baseline (in the parent study) in Dermatology Life Quality Index (DLQI) at each visit
- Change from baseline (in the parent study) in selected clinical laboratory test results
- Change from baseline in selected vital signs
- Serum concentration of afimkibart at specified timepoints
- Incidence and titres of ADA and NAb
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (26)
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