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

NCT06863961 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: CS455702024-515494-95-00
• Study Type: interventional
• Target: 160
• Locations: 8 countries
• Sites: 68

Brief 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).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16

  Baseline and Week 16

Secondary Outcomes (9)

• Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32

  At Week 16 and Week 32

• Percentage of Participants who Achieve EASI-75 Response at Week 32

  At Week 32

• Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32

  At Week 16 and Week 32

• Percent Change from Baseline in EASI by Visit

  Baseline up to end of study (approximately 1 year)

• Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit

  Baseline up to end of study (approximately 1 year)

Study Arms (4)

Afimkibart Group I

EXPERIMENTAL

Participants will receive afimkibart via subcutaneous (SC) injection.

Drug: Afimkibart

Afimkibart Group II

EXPERIMENTAL

Participants will receive afimkibart via SC injection.

Drug: Afimkibart

Afimkibart Group III

EXPERIMENTAL

Participants will receive afimkibart via SC injection.

Drug: Afimkibart

Placebo

PLACEBO COMPARATOR

Participants will receive placebo via SC injection.

Drug: Placebo

Interventions

Afimkibart DRUG

Afimkibart will be administered as SC injection.

Also known as: PF-06480605, RVT-3101, RO7790121

Afimkibart Group I; Afimkibart Group II; Afimkibart Group III

Placebo DRUG

Placebo will be administered as SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (68)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

The Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Dermatology Research Associate

Los Angeles, California, 90045, United States

Location

Suncoast Research Associates LLC - ERN - PPDS

Doral, Florida, 33172, United States

Location

Olympian Clinical Research

Tampa, Florida, 33615, United States

Location

Hamilton Research, LLC

Alpharetta, Georgia, 30022, United States

Location

Dermatology Affiliates Research Institute, LLC

Atlanta, Georgia, 30305, United States

Location

Dawes Fretzin Clinical Res LLC

Indianapolis, Indiana, 46250, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Regents of the University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Care Access Research - Hoboken

Hoboken, New Jersey, 07030, United States

Location

Forest Hill Dermatology Group

Kew Gardens, New York, 11415, United States

Location

Weill Cornell Medicine

New York, New York, 10075, United States

Location

Centricity Research Dublin

Columbus, Ohio, 43213, United States

Location

DOCS Clinical Research - Springfield

Springfield, Ohio, 45505, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73170, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Best Skin Research LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Arlington Research Center

Arlington, Texas, 76011, United States

Location

Modern Research Associates

Dallas, Texas, 75231, United States

Location

Reveal Research Institute

Dallas, Texas, 75235, United States

Location

Rainey & Finklea Dermatology d/b/a RFSA Dermatology, PLLC

San Antonio, Texas, 78213, United States

Location

Care Access Research - Arlington

Arlington, Virginia, 22206, United States

Location

Centro de Pesquisas da Clínica IBIS

Salvador, Estado de Bahia, 41820-020, Brazil

Location

Centro de Estudos em Terapias Inovadoras ? CETI

Curitiba, Paraná, 80030-110, Brazil

Location

Hospital de Clnicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

Botucatu, São Paulo, 18618-686, Brazil

Location

Centro de Pesquisa São Lucas

Campinas, São Paulo, 13034-685, Brazil

Location

HMCG - Hospital e Maternidade Dr. Christovo da Gama

Santo Andr, São Paulo, 09030-010, Brazil

Location

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

Rio de Janeiro, 20241-180, Brazil

Location

Dermatology Research Institute Inc.

Calgary, Alberta, T2J 7E1, Canada

Location

CARe Clinic

Red Deer, Alberta, T4P-1K4, Canada

Location

Centricity Research

London, Ontario, N6A 2C2, Canada

Location

DermEffects

London, Ontario, N6H 5L5, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

DermEdge

Mississauga, Ontario, L4Y4C5, Canada

Location

Ryan Clinical Research Inc

Newmarket, Ontario, L3Y 5G8, Canada

Location

Centre de Recherche Saint-Louis

Québec, G1W 4R4, Canada

Location

Hopital Charles Nicolle

Rouen, Nord, 76031, France

Location

Hopital Saint Louis

Cedex 10, Paris, 75010, France

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Klinisches Studienzentrum

Bad Bentheim, Lower Saxony, 48455, Germany

Location

Hautmedizin Saar

Merzig, Saarland, 66663, Germany

Location

DRK Krankenhaus Chemnitz-Rabenstein

Chemnitz, Saxony, 09117, Germany

Location

Harzklinikum Dorothea Christiane Erxleben GmbH

Quedlinburg, Saxony-Anhalt, 06484, Germany

Location

Dermatologikum Hamburg GmbH

Hamburg, 20354, Germany

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Emilia-Romagna, 00168, Italy

Location

Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20144, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco (Presidio G. Rodolico)

Catania, Sicily, 95123, Italy

Location

Azienda Ospedaliero Universitaria delle Marche

Ancona, The Marches, 60126, Italy

Location

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338, Poland

Location

Centrum Medyczne Pratia Katowice I

Katowice, 40-081, Poland

Location

Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski

Krakow, 30-002, Poland

Location

Centrum Nowoczesnych Terapii "Dobry Lekarz"

Krakow, 31-011, Poland

Location

Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

Rzeszów, 35-055, Poland

Location

LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki

Szczecin, 70-332, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, 00-872, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02-953, Poland

Location

Royalderm

Warsaw, 02-962, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501, Poland

Location

Complejo Hospitalario Universitario de Santiago.

Santiago de Compostela, LA Coruna, 15706, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Clinica Universidad de Navarra-Madrid

Madrid, 28027, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 7, 2025
• Study Start: April 1, 2025
• Primary Completion: July 22, 2026
• Study Completion (Estimated): February 3, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (5); IT (4); CA (8); US (25); PL (10); BR (8); FR (2); DE (6)