RecruitingPhase 2NCT06863961
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients With Moderate to Severe Atopic Dermatitis
Sponsor
Hoffmann-La Roche
Enrollment
160 participants
Start Date
Apr 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis (AD).
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening
- Moderate to severe AD
- At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study
Exclusion Criteria6
- 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
- IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study
- Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study
- Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline
- Acquired or congenital immunodeficiency
- Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study
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Interventions
DRUGAfimkibart
Afimkibart will be administered as SC injection.
DRUGPlacebo
Placebo will be administered as SC injection.
Locations(73)
View Full Details on ClinicalTrials.gov
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NCT06863961
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