Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (67)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
Coordinator of this site? Confirm its status
BotucatuBrazilUnknown status
Centro de Pesquisa Sao Lucas
Coordinator of this site? Confirm its status
CampinasBrazilUnknown status
Centro de Estudos em Terapias Inovadoras ? CETI
Coordinator of this site? Confirm its status
CuritibaBrazilUnknown status
Hospital de Clnicas de Porto Alegre
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Santa Casa de Misericordia de Porto Alegre
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilUnknown status
Clinica Ibis
Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status
HMCG - Hospital e Maternidade Dr. Christovo da Gama
Coordinator of this site? Confirm its status
Santo AndrBrazilUnknown 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 PretoBrazilUnknown status
Centricity Research London Victoria
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
Dermeffects
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
Lynderm Research Inc.
Coordinator of this site? Confirm its status
MarkhamCanadaUnknown status
DermEdge
Coordinator of this site? Confirm its status
MississaugaCanadaUnknown status
Centre de Recherche Saint-Louis
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Thermalsole und Schwefelbad Bentheim GmbH
Coordinator of this site? Confirm its status
Bad BentheimGermanyActive, not recruiting
Deutsches Rotes Kreuz Gemeinnuetzige Krankenhaus GmbH Sachsen
Coordinator of this site? Confirm its status
ChemnitzGermanyActive, not recruiting
Medical Center- University of Freiburg
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyActive, not recruiting
Dermatologikum Hamburg Gmbh
Coordinator of this site? Confirm its status
HamburgGermanyActive, not recruiting
CRS Clinical Research Services Management GmbH
Coordinator of this site? Confirm its status
KielGermanyActive, not recruiting
Hms GmbH
Coordinator of this site? Confirm its status
MerzigGermanyActive, not recruiting
Harzklinikum Dorothea Christiane Erxleben GmbH
Coordinator of this site? Confirm its status
QuedlinburgGermanyActive, not recruiting
Hospital General Universitario Dr. Balmis
Coordinator of this site? Confirm its status
AlicanteSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainActive, not recruiting
Hospital Universitario La Paz
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Clinica Universidad de Navarra
Coordinator of this site? Confirm its status
MadridSpainActive, not recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
Coordinator of this site? Confirm its status
Santiago de CompostelaSpainActive, not recruiting
Hospital Marina Baixa De La Vila Joiosa
Coordinator of this site? Confirm its status
VillajoyosaSpainActive, not recruiting
CHU Besancon
Coordinator of this site? Confirm its status
Besancon CedexFranceCompleted
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceCompleted
Centre Hospitalier Universitaire Rouen
Coordinator of this site? Confirm its status
Rouen CedexFranceCompleted
Azienda Ospedaliero-Universitaria delle Marche
Coordinator of this site? Confirm its status
AnconaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Coordinator of this site? Confirm its status
CataniaItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandCompleted
Pratia S.A.
Coordinator of this site? Confirm its status
GdyniaPolandCompleted
Pratia S.A.
Coordinator of this site? Confirm its status
KatowicePolandCompleted
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Coordinator of this site? Confirm its status
KrakowPolandCompleted
Dermoklinika Centrum Medyczne S.C., M. Kierstan, J. Narbutt, A. Lesiak
Coordinator of this site? Confirm its status
LodzPolandCompleted
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Coordinator of this site? Confirm its status
RzeszówPolandCompleted
Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki
Coordinator of this site? Confirm its status
SzczecinPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
TorunPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Klinika Ambroziak Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Medical Network Sp z o o
Coordinator of this site? Confirm its status
WarsawPolandCompleted
ROYALDERM AGNIESZKA NAWROCKA
Coordinator of this site? Confirm its status
WarszawaPolandCompleted
Hamilton Research LLC
Coordinator of this site? Confirm its status
AlpharettaUnited StatesUnknown status
Arlington Research Center
Coordinator of this site? Confirm its status
ArlingtonUnited StatesUnknown status
Dermatology Affiliates Research Institute, LLC
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Best Skin Research, LLC
Coordinator of this site? Confirm its status
Camp HillUnited StatesUnknown status
Centricity Research Columbus Dermatology
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Modern Research Associates
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Reveal Research Institute
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
First OC Dermatology
Coordinator of this site? Confirm its status
Fountain ValleyUnited StatesUnknown status
Cumberland Skin Center for Clinical Research LLC
Coordinator of this site? Confirm its status
HermitageUnited StatesUnknown status
Care Access Research - Hoboken
Coordinator of this site? Confirm its status
HobokenUnited StatesUnknown status
Dawes Fretzin Clinical Res LLC
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Dermatology Research Associate
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
UCLA Division of Dermatology
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Regents of the University of Minnesota
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Southern Indiana Clinical trials
Coordinator of this site? Confirm its status
New AlbanyUnited StatesUnknown status
Central Sooner Research
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Oregon Health Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Olympian Clinical Research
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Revival Research Institute, LLC
Coordinator of this site? Confirm its status
TroyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.