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

May 8, 2026 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41820-020
        • Centro de Pesquisas da Clínica IBIS
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Centro de Estudos em Terapias Inovadoras ? CETI
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
        • Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clnicas de Porto Alegre
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
      • Campinas, São Paulo, Brazil, 13034-685
        • Centro de Pesquisa Sao Lucas
      • Santo Andr, São Paulo, Brazil, 09030-010
        • HMCG - Hospital e Maternidade Dr. Christovo da Gama
  • Canada
      • Québec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute Inc.
      • Red Deer, Alberta, Canada, T4P-1K4
        • CaRe Clinic
    • Ontario
      • London, Ontario, Canada, N6H 5L5
        • DermEffects
      • London, Ontario, Canada, N6A 2C2
        • Centricity Research
      • Markham, Ontario, Canada, L3P 1X3
        • Lynderm Research Inc
      • Mississauga, Ontario, Canada, L4Y4C5
        • DermEdge
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Ryan Clinical Research Inc
  • France
    • Nord
      • Rouen, Nord, France, 76031
        • Hôpital Charles Nicolle
    • Paris
      • Cedex 10, Paris, France, 75010
        • Hôpital Saint Louis
  • Germany
      • Hamburg, Germany, 20354
        • Dermatologikum Hamburg GmbH
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79104
        • Universitaetsklinikum Freiburg
    • Lower Saxony
      • Bad Bentheim, Lower Saxony, Germany, 48455
        • Klinisches Studienzentrum
    • Saarland
      • Merzig, Saarland, Germany, 66663
        • Hautmedizin Saar
    • Saxony
      • Chemnitz, Saxony, Germany, 09117
        • Drk Krankenhaus Chemnitz-Rabenstein
    • Saxony-Anhalt
      • Quedlinburg, Saxony-Anhalt, Germany, 06484
        • Harzklinikum Dorothea Christiane Erxleben GmbH
  • Italy
    • Emilia-Romagna
      • Roma, Emilia-Romagna, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardy
      • Milan, Lombardy, Italy, 20144
        • Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico
    • Sicily
      • Catania, Sicily, Italy, 95123
        • Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco (Presidio G. Rodolico)
    • The Marches
      • Ancona, The Marches, Italy, 60126
        • Azienda Ospedaliero Universitaria delle Marche
  • Poland
      • Gdynia, Poland, 81-338
        • Centrum Medyczne Pratia Gdynia
      • Katowice, Poland, 40-081
        • Centrum Medyczne Pratia Katowice I
      • Krakow, Poland, 31-011
        • Centrum Nowoczesnych Terapii "Dobry Lekarz"
      • Krakow, Poland, 30-002
        • Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski
      • Rzeszów, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
      • Szczecin, Poland, 70-332
        • LASER CLINIC S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki
      • Warsaw, Poland, 04-501
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warsaw, Poland, 02-953
        • Klinika Ambroziak Dermatologia
      • Warsaw, Poland, 02-962
        • Royalderm
      • Warsaw, Poland, 00-872
        • MICS Centrum Medyczne Warszawa
  • Spain
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra-Madrid
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago.
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universitaria de Navarra
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • Fremont, California, United States, 94538
        • The Center for Dermatology Clinical Research
      • Los Angeles, California, United States, 90024
        • University of California Los Angeles
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associate
    • Florida
      • Doral, Florida, United States, 33172
        • Suncoast Research Associates LLC - ERN - PPDS
      • Tampa, Florida, United States, 33615
        • Olympian Clinical Research
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Hamilton Research, LLC
      • Atlanta, Georgia, United States, 30305
        • Dermatology Affiliates Research Institute, LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Dawes Fretzin Clinical Res LLC
      • New Albany, Indiana, United States, 47150
        • Southern Indiana Clinical trials
    • Michigan
      • Troy, Michigan, United States, 48084
        • Revival Research Institute, LLC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Regents of the University of Minnesota
    • New Jersey
      • Hoboken, New Jersey, United States, 07030
        • Care Access Research - Hoboken
    • New York
      • Kew Gardens, New York, United States, 11415
        • Forest Hill Dermatology Group
      • New York, New York, United States, 10075
        • Weill Cornell Medicine
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Centricity Research Dublin
      • Springfield, Ohio, United States, 45505
        • DOCS Clinical Research - Springfield
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73170
        • Central Sooner Research
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Best Skin Research LLC
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center
      • Dallas, Texas, United States, 75231
        • Modern Research Associates
      • Dallas, Texas, United States, 75235
        • Reveal Research Institute
      • San Antonio, Texas, United States, 78213
        • Rainey & Finklea Dermatology d/b/a RFSA Dermatology, PLLC
    • Virginia
      • Arlington, Virginia, United States, 22206
        • Care Access Research - Arlington

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo via SC injection.
Drug: Placebo
Placebo will be administered as SC injection.
Experimental: Afimkibart Group I
Participants will receive afimkibart via subcutaneous (SC) injection.
Drug: Afimkibart
Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121
Experimental: Afimkibart Group II
Participants will receive afimkibart via SC injection.
Drug: Afimkibart
Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121
Experimental: Afimkibart Group III
Participants will receive afimkibart via SC injection.
Drug: Afimkibart
Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • PF-06480605
  • RO7790121

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: At Week 16 and Week 32
At Week 16 and Week 32
Percentage of Participants who Achieve EASI-75 Response at Week 32
Time Frame: At Week 32
At Week 32
Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32
Time Frame: At Week 16 and Week 32
At Week 16 and Week 32
Percent Change from Baseline in EASI by Visit
Time Frame: Baseline up to end of study (approximately 1 year)
Baseline up to end of study (approximately 1 year)
Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit
Time Frame: Baseline up to end of study (approximately 1 year)
Baseline up to end of study (approximately 1 year)
Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit
Time Frame: Baseline, weeks 4, 10, 16, 22 and 32
Baseline, weeks 4, 10, 16, 22 and 32
Percentage of EASI-75 Responders at Week 16
Time Frame: At Week 16
At Week 16
Percentage of Participants with Adverse Events
Time Frame: Baseline up to end of study (approximately 1 year)
Baseline up to end of study (approximately 1 year)
Serum Concentration of Afimkibart at Specified Timepoints
Time Frame: Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.
Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, 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 Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

July 22, 2026

Study Completion (Estimated)

February 3, 2027

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS45570
  • 2024-515494-95-00 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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