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

August 6, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Clinica 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
      • Sao Jose Rio Preto, São Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
  • Canada
      • Québec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
    • Alberta
      • Calgary, Alberta, Canada, T2J 7E1
        • Dermatology Research Institute Inc.
    • 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, L4Y 4C5
        • 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
        • Hopital 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"
      • Rzeszów, Poland, 35-055
        • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
      • Warsaw, Poland, 02-953
        • Klinika Ambroziak Dermatologia
      • 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
      • Fremont, California, United States, 94538
        • The Center for Dermatology Clinical Research
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associate
      • Los Angeles, California, United States, 90024
        • UCLA Division of Dermatology
    • Florida
      • Fort Myers, Florida, United States, 33912
        • AMR Fort Myers
      • 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 Columbus Dermatology
    • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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