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
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Dermatology Research Associate
RECRUITING
Los Angeles
University of California Los Angeles
RECRUITING
Los Angeles
Florida
Suncoast Research Associates LLC - ERN - PPDS
RECRUITING
Doral
Olympian Clinical Research
RECRUITING
Tampa
Georgia
Hamilton Research, LLC
RECRUITING
Alpharetta
Dermatology Affiliates Research Institute, LLC
RECRUITING
Atlanta
Indiana
Dawes Fretzin Clinical Res LLC
RECRUITING
Indianapolis
Michigan
Revival Research Institute, LLC
RECRUITING
Troy
Minnesota
Regents of the University of Minnesota
RECRUITING
Minneapolis
New Jersey
Care Access Research - Hoboken
RECRUITING
Hoboken
Ohio
Centricity Research Dublin
RECRUITING
Dublin
DOCS Clinical Research - Springfield
RECRUITING
Springfield
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Best Skin Research LLC
RECRUITING
Camp Hill
Tennessee
Goodlettsville Dermatology Research
RECRUITING
Goodlettsville
Cumberland Skin Center for Clinical Research LLC
RECRUITING
Hermitage
Texas
Arlington Research Center
RECRUITING
Arlington
Modern Research Associates
RECRUITING
Dallas
Reveal Research Institute
RECRUITING
Dallas
Virginia
Care Access Research - Arlington
RECRUITING
Arlington
Other Locations
Brazil
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A
RECRUITING
Rio De Janeiro
Canada
Centricity Research
RECRUITING
London
DermEffects
RECRUITING
London
Lynde Institute for Dermatology
RECRUITING
Markham
DermEdge
RECRUITING
Mississauga
Centre de Recherche Saint-Louis
RECRUITING
Québec
CARe Clinic
RECRUITING
Red Deer
Germany
Klinisches Studienzentrum
RECRUITING
Bad Bentheim
DRK Krankenhaus Chemnitz-Rabenstein
RECRUITING
Chemnitz
Dermatologikum Hamburg GmbH
RECRUITING
Hamburg
CRS Clinical Research Services Kiel GmbH
RECRUITING
Kiel
Harzklinikum Dorothea Christiane Erxleben GmbH
RECRUITING
Quedlinburg
Italy
Azienda Ospedaliero Universitaria delle Marche
RECRUITING
Ancona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Poland
Centrum Medyczne Pratia Gdynia
RECRUITING
Gdynia
Centrum Medyczne Pratia Katowice I
RECRUITING
Katowice
Centrum Nowoczesnych Terapii Dobry Lekarz
RECRUITING
Krakow
Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski
RECRUITING
Krakw
Dermoklinika
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie
RECRUITING
Rzeszów
MICS Centrum Medyczne Torun
RECRUITING
Torun
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Spain
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Contact Information
Primary
Reference Study ID Number: CS45570 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 160
Treatments
Experimental: Afimkibart Group I
Participants will receive afimkibart via subcutaneous (SC) injection.
Experimental: Afimkibart Group II
Participants will receive afimkibart via SC injection.
Experimental: Afimkibart Group III
Participants will receive afimkibart via SC injection.
Placebo_comparator: Placebo
Participants will receive placebo via SC injection.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche