RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-04-01

Study Completion:2026-11-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06863961

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

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

CONTACT

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Dermatology Research Associate

Los Angeles, California, 90045

United States

Suncoast Research Associates LLC - ERN - PPDS

Miami, Florida, 33173

United States

Olympian Clinical Research

Tampa, Florida, 33615

United States

Hamilton Research, LLC

Alpharetta, Georgia, 30022

United States

Dermatology Affiliates Research Institute, LLC

Atlanta, Georgia, 30305

United States

Dawes Fretzin Clinical Res LLC

Indianapolis, Indiana, 46250

United States

Revival Research Institute, LLC

Troy, Michigan, 48084

United States

Care Access Research - Hoboken

Hoboken, New Jersey, 07030

United States

Centricity Research Dublin

Dublin, Ohio, 43016

United States

Best Skin Research LLC

Camp Hill, Pennsylvania, 17011

United States

Goodlettsville Dermatology Research

Goodlettsville, Tennessee, 37072

United States

Cumberland Skin Center for Clinical Research LLC

Hermitage, Tennessee, 37076

United States

Arlington Research Center

Arlington, Texas, 76011

United States

Modern Research Associates

Dallas, Texas, 75231

United States

Reveal Research Institute

Dallas, Texas, 75235

United States

Care Access Research - Arlington

Arlington, Virginia, 22206

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01

Study Completion Date2026-11-26

Study Record Updates

Study Start Date2025-04-01

Study Completion Date2026-11-26

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis