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

Last updated: May 6, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

2

Condition

Atopic Dermatitis

Allergy

Hives (Urticaria)

Treatment

RO7790121

Placebo

Clinical Study ID

NCT06863961
CS45570
2024-515494-95-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of RO7790121 in participants with moderate to severe atopic dermatitis (AD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria atleast 1 year prior to screening

  • Moderate to severe AD

  • At least once daily use of an additive-free, bland emollient for at least 7 daysprior to the baseline visit and during the study

Exclusion

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, allergiccontact dermatitis

  • IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasalcorticosteroids are allowed) within 4 weeks of the baseline visit and during thestudy

  • Topical treatment for AD including, but not limited to topical corticosteroids,topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescriptionmoisturizers 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 withparenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2weeks prior to baseline

  • Acquired or congenital immunodeficiency

  • Systemic therapies that are also used in the treatment of AD, including, but notlimited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4weeks of the baseline visit and during the study

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: RO7790121
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
November 19, 2026

Connect with a study center

  • Dermatology Research Associate

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Res LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Revival Research Institute, LLC

    Troy, Michigan 48084
    United States

    Active - Recruiting

  • Best Skin Research LLC

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • DermDox Centers for Dermatology

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • Goodlettsville Dermatology Research

    Goodlettsville, Tennessee 37072
    United States

    Active - Recruiting

  • Arlington Research Center

    Arlington, Texas 76011
    United States

    Active - Recruiting

  • Reveal Research Institute

    Dallas, Texas 75235
    United States

    Active - Recruiting

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