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

Launched by HOFFMANN-LA ROCHE · Mar 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RO7790121 for people with moderate to severe atopic dermatitis, which is a skin condition that causes itchy and inflamed skin. The goal of the study is to see if this treatment is effective and safe for patients. If you or a family member have been diagnosed with atopic dermatitis for at least a year and have been using a simple, gentle moisturizer daily, you might be eligible to participate.

Participants in this trial will be required to avoid certain medications and treatments for their skin condition before and during the study, including specific types of steroids and other topical treatments. If you join, you can expect regular visits to assess your skin condition and monitor your health while using this new treatment. This trial is currently looking for participants of all genders aged 18 and older, and it aims to find better ways to manage atopic dermatitis.

Gender

ALL

Eligibility criteria

• 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