RecruitingPhase 2NCT07223697
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
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
Sponsor
Hoffmann-La Roche
Enrollment
120 participants
Start Date
Jan 8, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria4
- 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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Interventions
DRUGAfimkibart
Afimkibart SC injection will be administered as per the schedule defined in the protocol.
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT07223697
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