A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID

NCT06863961

Run by

Hoffmann-La Roche

People needed

160

Starts

2025-04-01

Expected to finish

2027-02-03

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Center for Dermatology Clinical Research — Fremont, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Dermatology Research Associate — Los Angeles, California, United States
• Suncoast Research Associates LLC - ERN - PPDS — Doral, Florida, United States
• Olympian Clinical Research — Tampa, Florida, United States
• Hamilton Research, LLC — Alpharetta, Georgia, United States
• Dermatology Affiliates Research Institute, LLC — Atlanta, Georgia, United States
• Dawes Fretzin Clinical Res LLC — Indianapolis, Indiana, United States
• Southern Indiana Clinical Trials — New Albany, Indiana, United States
• Revival Research Institute, LLC — Troy, Michigan, United States
• Regents of the University of Minnesota — Minneapolis, Minnesota, United States
• Care Access Research - Hoboken — Hoboken, New Jersey, United States
• Forest Hill Dermatology Group — Kew Gardens, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Centricity Research Dublin — Columbus, Ohio, United States
• DOCS Clinical Research - Springfield — Springfield, Ohio, United States
• Central Sooner Research — Oklahoma City, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Best Skin Research LLC — Camp Hill, Pennsylvania, United States
• Arlington Research Center — Arlington, Texas, United States
• Modern Research Associates — Dallas, Texas, United States
• Reveal Research Institute — Dallas, Texas, United States
• Rainey & Finklea Dermatology d/b/a RFSA Dermatology, PLLC — San Antonio, Texas, United States
• Care Access Research - Arlington — Arlington, Virginia, United States
• First OC Dermatology — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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