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Clinical Trials in the USA / NCT07223697
Recruiting Phase 2

A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis

NCT07223697 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2026-01-08
Last updated
2026-09-04

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Afimkibart

Afimkibart: Afimkibart SC injection will be administered as per the schedule defined in the protocol.

Study summary

This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Ability and willingness to comply with all aspects of the protocol including completion of the efficacy assessments (EASI and IGA), clinical outcome assessment instruments (DLQI, POEM), and safety and PK sample collections for the duration of the study Parent Clinical Trial-Specific Criteria: * Study CS45570 participants who continued to be evaluated at the Week 36 follow up visit and achieved =\> EASI50 response from study baseline Exclusion Criteria: * Evidence of other skin conditions that would interfere with the assessment of AD * Withdrawal of consent and/or premature discontinuation from parent study * Any permanent discontinuation of study drug in parent study * History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of Afimkibart

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
UCLA Division of Dermatology Los Angeles California Recruiting
Dermatology Research Associate Los Angeles California Recruiting
Olympian Clinical Research Tampa Florida Recruiting
Hamilton Research, LLC Alpharetta Georgia Recruiting
Revival Research Institute, LLC Troy Michigan Recruiting
Best Skin Research LLC Camp Hill Pennsylvania Recruiting
Centro de Estudos em Terapias Inovadoras ? CETI Curitiba Paraná Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Hospital de Clnicas de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu São Paulo Recruiting
Centro de Pesquisa São Lucas Campinas São Paulo Recruiting
HMCG - Hospital e Maternidade Dr. Christovo da Gama Santo Andr São Paulo Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS Sao Jose Rio Preto São Paulo Recruiting
Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Rio de Janeiro Brazil Recruiting
DermEffects London Ontario Recruiting
Lynderm Research Inc Markham Ontario Recruiting
DermEdge Mississauga Ontario Recruiting
Ryan Clinical Research Inc Newmarket Ontario Recruiting
Fachklinik Bad Bentheim Bad Bentheim Lower Saxony Recruiting
Dermatologikum Hamburg Gemeinschaftspraxis GbR Hamburg Germany Recruiting
Azienda Ospedaliero Universitaria delle Marche Ancona The Marches Recruiting
Centrum Medyczne Pratia Katowice I Katowice Silesian Voivodeship Recruiting
Centrum Medyczne Pratia Gdynia Gdynia Poland Recruiting
Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski Krakow Poland Recruiting
Centrum Nowoczesnych Terapii "Dobry Lekarz" Krakow Poland Recruiting
Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie Rzeszów Poland Recruiting
Klinika Ambroziak Dermatologia Warsaw Poland Recruiting
Clinica Universidad de Navarra Pamplona Navarre Recruiting
Hospital Universitario Reina Sofia Córdoba Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07223697 on ClinicalTrials.gov ↗ ← All trials in the USA