NCT06863961Active, not recruitingPhase 2
A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 162 (actual)
- First submitted
- 4 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 22 Jul 2026
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06863961
- EU CT number
- 2024-515494-95-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 162
- From 1 Apr 2025 to the primary completion date, 22 Jul 2026
- 67 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
Other
- Acquired or congenital immunodeficiency
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (67)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu Coordinator of this site? Confirm its status | Botucatu | Brazil | Unknown status |
| Centro de Pesquisa Sao Lucas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Centro de Estudos em Terapias Inovadoras ? CETI Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital de Clnicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Santa Casa de Misericordia de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Clinica Ibis Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| HMCG - Hospital e Maternidade Dr. Christovo da Gama Coordinator of this site? Confirm its status | Santo Andr | Brazil | Unknown status |
| Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS Coordinator of this site? Confirm its status | Sao Jose Rio Preto | Brazil | Unknown status |
| Centricity Research London Victoria Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Dermeffects Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Lynderm Research Inc. Coordinator of this site? Confirm its status | Markham | Canada | Unknown status |
| DermEdge Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Thermalsole und Schwefelbad Bentheim GmbH Coordinator of this site? Confirm its status | Bad Bentheim | Germany | Active, not recruiting |
| Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen Coordinator of this site? Confirm its status | Chemnitz | Germany | Active, not recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| Dermatologikum Hamburg Gmbh Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| CRS Clinical Research Services Management GmbH Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Hms GmbH Coordinator of this site? Confirm its status | Merzig | Germany | Active, not recruiting |
| Harzklinikum Dorothea Christiane Erxleben GmbH Coordinator of this site? Confirm its status | Quedlinburg | Germany | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Marina Baixa De La Vila Joiosa Coordinator of this site? Confirm its status | Villajoyosa | Spain | Active, not recruiting |
| CHU Besancon Coordinator of this site? Confirm its status | Besancon Cedex | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c. Coordinator of this site? Confirm its status | Krakow | Poland | Completed |
| Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie Coordinator of this site? Confirm its status | Rzeszów | Poland | Completed |
| Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Klinika Ambroziak Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| ROYALDERM AGNIESZKA NAWROCKA Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| Hamilton Research LLC Coordinator of this site? Confirm its status | Alpharetta | United States | Unknown status |
| Arlington Research Center Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Dermatology Affiliates Research Institute, LLC Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Best Skin Research, LLC Coordinator of this site? Confirm its status | Camp Hill | United States | Unknown status |
| Centricity Research Columbus Dermatology Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Modern Research Associates Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Reveal Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| First OC Dermatology Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Cumberland Skin Center for Clinical Research LLC Coordinator of this site? Confirm its status | Hermitage | United States | Unknown status |
| Care Access Research - Hoboken Coordinator of this site? Confirm its status | Hoboken | United States | Unknown status |
| Dawes Fretzin Clinical Res LLC Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Dermatology Research Associate Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Division of Dermatology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Regents of the University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Southern Indiana Clinical trials Coordinator of this site? Confirm its status | New Albany | United States | Unknown status |
| Central Sooner Research Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Olympian Clinical Research Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Revival Research Institute, LLC Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.