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New shot could tame tough eczema

NCT ID NCT06863961

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tests a new drug called Afimkibart (RO7790121) in 160 adults with moderate to severe atopic dermatitis (eczema). Participants receive either the drug or a placebo as a shot under the skin. The main goal is to see if the drug improves eczema symptoms by at least 75% after 16 weeks, with safety monitored throughout.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Afimkibart (also called RO7790121), a drug given as a shot under the skin
What this could lead to
If it works, this could point toward a new treatment option for people with moderate to severe eczema that is not well controlled by current therapies.
What could go wrong
This is an early Phase 2 trial with only 160 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

162 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • AMR Fort Myers

    Fort Myers, Florida, 33912, United States

  • Arlington Research Center

    Arlington, Texas, 76011, United States

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

    Catania, Sicily, 95123, Italy

  • Azienda Ospedaliero Universitaria delle Marche

    Ancona, The Marches, 60126, Italy

  • Best Skin Research LLC

    Camp Hill, Pennsylvania, 17011, United States

  • Care Access Research - Hoboken

    Hoboken, New Jersey, 07030, United States

  • Central Sooner Research

    Oklahoma City, Oklahoma, 73170, United States

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4, Canada

  • Centricity Research

    London, Ontario, N6A 2C2, Canada

  • Centricity Research Columbus Dermatology

    Columbus, Ohio, 43213, United States

  • Centro de Estudos em Terapias Inovadoras ? CETI

    Curitiba, Paraná, 80030-110, Brazil

  • Centro de Pesquisa São Lucas

    Campinas, São Paulo, 13034-685, Brazil

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338, Poland

  • Centrum Medyczne Pratia Katowice I

    Katowice, 40-081, Poland

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, 31-011, Poland

  • Clinica Ibis

    Salvador, Estado de Bahia, 41820-020, Brazil

  • Clinica Universidad de Navarra-Madrid

    Madrid, 28027, Spain

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna, 15706, Spain

  • DRK Krankenhaus Chemnitz-Rabenstein

    Chemnitz, Saxony, 09117, Germany

  • Dawes Fretzin Clinical Res LLC

    Indianapolis, Indiana, 46250, United States

  • DermEdge

    Mississauga, Ontario, L4Y 4C5, Canada

  • DermEffects

    London, Ontario, N6H 5L5, Canada

  • Dermatologikum Hamburg GmbH

    Hamburg, 20354, Germany

  • Dermatology Affiliates Research Institute, LLC

    Atlanta, Georgia, 30305, United States

  • Dermatology Research Associate

    Los Angeles, California, 90045, United States

  • Dermatology Research Institute Inc.

    Calgary, Alberta, T2J 7E1, Canada

  • Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20144, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Emilia-Romagna, 00168, Italy

  • Forest Hill Dermatology Group

    Kew Gardens, New York, 11415, United States

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

    Sao Jose Rio Preto, São Paulo, 15090-000, Brazil

  • HMCG - Hospital e Maternidade Dr. Christovo da Gama

    Santo Andr, São Paulo, 09030-010, Brazil

  • Hamilton Research, LLC

    Alpharetta, Georgia, 30022, United States

  • Harzklinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg, Saxony-Anhalt, 06484, Germany

  • Hautmedizin Saar

    Merzig, Saarland, 66663, Germany

  • Hopital Charles Nicolle

    Rouen, Nord, 76031, France

  • Hopital Saint Louis

    Cedex 10, Paris, 75010, France

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital de Clnicas de Porto Alegre

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

  • Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

    Rio de Janeiro, 20241-180, Brazil

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953, Poland

  • Klinisches Studienzentrum

    Bad Bentheim, Lower Saxony, 48455, Germany

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3, Canada

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00-872, Poland

  • Modern Research Associates

    Dallas, Texas, 75231, United States

  • Olympian Clinical Research

    Tampa, Florida, 33615, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Regents of the University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • Reveal Research Institute

    Dallas, Texas, 75235, United States

  • Revival Research Institute, LLC

    Troy, Michigan, 48084, United States

  • Ryan Clinical Research Inc

    Newmarket, Ontario, L3Y 5G8, Canada

  • Santa Casa de Misericordia de Porto Alegre

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

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150, United States

  • The Center for Dermatology Clinical Research

    Fremont, California, 94538, United States

  • UCLA Division of Dermatology

    Los Angeles, California, 90024, United States

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

    Botucatu, São Paulo, 18618-686, Brazil

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

  • Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

    Rzeszów, 35-055, Poland

  • Weill Cornell Medicine

    New York, New York, 10075, United States

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