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Recruiting Phase 2 NCT07223697

A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

Trial Parameters

Condition Atopic Dermatitis
Sponsor Hoffmann-La Roche
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-08
Completion 2033-02-11
Interventions
Afimkibart

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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