Status:
RECRUITING
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- 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
Key Trial Info
Start Date :
January 8 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 11 2033
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07223697
Start Date
January 8 2026
End Date
February 11 2033
Last Update
December 22 2025
Active Locations (1)
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1
Best Skin Research LLC
Camp Hill, Pennsylvania, United States, 17011