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

RECRUITINGPHASE2

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

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

NCT06863961•Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (67)

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

Key Dates

Start Date

April 1, 2025

Primary Completion Date

October 5, 2026

Completion Date

April 19, 2027

Last Updated

March 12, 2026

Enrollment

160

ESTIMATED participants

Conditions

Atopic Dermatitis

Interventions

Afimkibart

DRUG

Placebo

DRUG

Contacts

Reference Study ID Number: CS45570 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis

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