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Clinical Trials in Brazil / NCT06863961
Active, not recruiting Phase 2

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

NCT06863961 · tracked via the Priya Life Science Brazil tracker
Phase
Phase 2
Started
2025-04-01
Last updated
2026-08-10

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Afimkibart →Placebo

Afimkibart: Afimkibart will be administered as SC injection.

Placebo: Placebo will be administered as SC injection.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (60)

FacilityCityRegionStatus
The Center for Dermatology Clinical Research Fremont California
UCLA Division of Dermatology Los Angeles California
Dermatology Research Associate Los Angeles California
AMR Fort Myers Fort Myers Florida
Olympian Clinical Research Tampa Florida
Hamilton Research, LLC Alpharetta Georgia
Dermatology Affiliates Research Institute, LLC Atlanta Georgia
Dawes Fretzin Clinical Res LLC Indianapolis Indiana
Southern Indiana Clinical Trials New Albany Indiana
Revival Research Institute, LLC Troy Michigan
Regents of the University of Minnesota Minneapolis Minnesota
Care Access Research - Hoboken Hoboken New Jersey
Forest Hill Dermatology Group Kew Gardens New York
Weill Cornell Medicine New York New York
Centricity Research Columbus Dermatology Columbus Ohio
Central Sooner Research Oklahoma City Oklahoma
Oregon Health & Science University Portland Oregon
Best Skin Research LLC Camp Hill Pennsylvania
Arlington Research Center Arlington Texas
Modern Research Associates Dallas Texas
Reveal Research Institute Dallas Texas
Clinica Ibis Salvador Estado de Bahia
Centro de Estudos em Terapias Inovadoras ? CETI Curitiba Paraná
Hospital de Clnicas de Porto Alegre Porto Alegre Rio Grande do Sul
Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu São Paulo
Centro de Pesquisa São Lucas Campinas São Paulo
HMCG - Hospital e Maternidade Dr. Christovo da Gama Santo Andr São Paulo
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS Sao Jose Rio Preto São Paulo
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Rio de Janeiro Brazil
Dermatology Research Institute Inc. Calgary Alberta
Centricity Research London Ontario
DermEffects London Ontario
Lynderm Research Inc Markham Ontario
DermEdge Mississauga Ontario
Ryan Clinical Research Inc Newmarket Ontario
Centre de Recherche Saint-Louis Québec Canada
Hopital Charles Nicolle Rouen Nord
Hopital Saint Louis Cedex 10 Paris
Universitaetsklinikum Freiburg Freiburg im Breisgau Baden-Wurttemberg

+ 20 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06863961 on ClinicalTrials.gov ↗ ← All trials in Brazil