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Atopic DermatitisPhase 2NCT06863961

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

A Phase 2 study testing Afimkibart in people with Atopic Dermatitis, run by Hoffmann-La Roche at 52 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Afimkibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
52 sitesin 8 countries
Study dates
1 Apr 2025to 30 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

52 sites in 8 countries.

52 sites in 8 countries

United States19 sites

  • Hamilton Research, LLC

    Alpharetta, Georgia, 30022

  • Arlington Research Center

    Arlington, Texas, 76011

  • Dermatology Affiliates Research Institute, LLC

    Atlanta, Georgia, 30305

  • Best Skin Research LLC

    Camp Hill, Pennsylvania, 17011

  • Centricity Research Columbus Dermatology

    Columbus, Ohio, 43213

  • Modern Research Associates

    Dallas, Texas, 75231

  • Reveal Research Institute

    Dallas, Texas, 75235

  • First OC Dermatology

    Fountain Valley, California, 92708

  • Cumberland Skin Center for Clinical Research LLC

    Hermitage, Tennessee, 37076

  • Care Access Research - Hoboken

    Hoboken, New Jersey, 07030

  • Dawes Fretzin Clinical Res LLC

    Indianapolis, Indiana, 46250

  • UCLA Division of Dermatology

    Los Angeles, California, 90024

  • Dermatology Research Associate

    Los Angeles, California, 90045

  • Regents of the University of Minnesota

    Minneapolis, Minnesota, 55455

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73170

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Olympian Clinical Research

    Tampa, Florida, 33615

  • Revival Research Institute, LLC

    Troy, Michigan, 48084

Other trials in United States

Brazil9 sites

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

    Botucatu, São Paulo, 18618-686

  • Centro de Pesquisa São Lucas

    Campinas, São Paulo, 13034-685

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curitiba, Paraná, 80030-110

  • Hospital de Clnicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, 20241-180

  • Clinica Ibis

    Salvador, Estado de Bahia, 41820-020

  • HMCG - Hospital e Maternidade Dr. Christovo da Gama

    Santo Andr, São Paulo, 09030-010

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

    Sao Jose Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Poland7 sites

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • Centrum Medyczne Pratia Katowice I

    Katowice, 40-081

  • Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski

    Krakow, 30-002

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, 31-011

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszów, 35-055

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-872

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953

Other trials in Poland

Canada5 sites

  • Centricity Research London Victoria

    London, Ontario, N6A 2C2

  • DermEffects

    London, Ontario, N6H 5L5

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • DermEdge

    Mississauga, Ontario, L4Y 4C5

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

Other trials in Canada

Italy4 sites

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, The Marches, 60126

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

    Catania, Sicily, 95123

  • Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20144

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Emilia-Romagna, 00168

Other trials in Italy

Spain4 sites

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna, 15706

Other trials in Spain

Germany3 sites

  • Klinisches Studienzentrum

    Bad Bentheim, Lower Saxony, 48455

  • DRK Krankenhaus Chemnitz-Rabenstein

    Chemnitz, Saxony, 09117

  • Dermatologikum Hamburg GmbH

    Hamburg, 20354

Other trials in Germany

France1 site

  • Hopital Saint Louis

    Cedex 10, Paris, 75010

Other trials in France

About this study

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

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).

Being tested
Afimkibart, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfimkibartDrug

    Also called PF-06480605, RVT-3101, RO7790121

    Afimkibart will be administered as SC injection.

  • PlaceboDrug

    Placebo will be administered as SC injection.

Study groups in NCT06863961
Study groupRoleWhat they receive
Afimkibart Group IExperimentalParticipants will receive afimkibart via subcutaneous (SC) injection.
Receives: Drug: Afimkibart
Afimkibart Group IIExperimentalParticipants will receive afimkibart via SC injection.
Receives: Drug: Afimkibart
Afimkibart Group IIIExperimentalParticipants will receive afimkibart via SC injection.
Receives: Drug: Afimkibart
PlaceboPlacebo comparatorParticipants will receive placebo via SC injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and Week 16

Secondary outcomes (9)

  1. 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

    Measured: At Week 16 and Week 32

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

    Measured: At Week 32

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

    Measured: At Week 16 and Week 32

  4. Percent Change from Baseline in EASI by Visit

    Measured: Baseline up to end of study (approximately 1 year)

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

    Measured: Baseline up to end of study (approximately 1 year)

  6. Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit

    Measured: Baseline, weeks 4, 10, 16, 22 and 32

  7. Percentage of EASI-75 Responders at Week 16

    Measured: At Week 16

  8. Percentage of Participants with Adverse Events

    Measured: Baseline up to end of study (approximately 1 year)

  9. Serum Concentration of Afimkibart at Specified Timepoints

    Measured: Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion22 Jul 2026
  4. Study completion30 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06863961
Sponsor's protocol ID
CS45570
Other IDs
2024-515494-95-00
Status last verified
Nov 2026
First submitted
4 Mar 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Afimkibart in people with Atopic Dermatitis, run by Hoffmann-La Roche at 52 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Brazil, Poland, Canada, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06863961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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