A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate… (NCT06863961) | Clinical Trial Compass
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
United States160 participantsStarted 2025-04-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16
Timeframe: Baseline and Week 16
Trial details
NCT IDNCT06863961
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-10-05
Contact for this trial
Reference Study ID Number: CS45570 https://forpatients.roche.com/