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A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
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Autoimmunerkrankung -
Neurodermitis
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Basisinformationen
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Studien-ID
NCT06863961, CS45570, 2024-515494-95-00
Condition
Atopic Dermatitis
Official Title
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
Studienzusammenfassung
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).
Einschlusskriterien
All
≥18 Years
No
Inclusion Criteria
- 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 Criteria
- 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
Diese Seite fasst Informationen von öffentlichen Studienregister-Websites wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. zusammen. Weitere Informationen zu dieser Studie finden Sie auf der Registerkarte „Für medizinische Fachkräfte" oder auf einer der Studienregister-Websites.
Die Informationen stammen direkt von Websites öffentlicher Register wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. und wurden nicht modifiziert.
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