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NCT07223697PHASE2Recruiting

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

Hoffmann-La Roche

Start Date

1/8/2026

Completion Date

3/1/2033

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Afimkibart

Interested in This Trial?

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Conditions

Atopic Dermatitis

Locations

Hamilton Research, LLC

Alpharetta, Georgia 30022

United States

Revival Research Institute, LLC

Troy, Michigan 48084

United States

Best Skin Research LLC

Camp Hill, Pennsylvania 17011

United States

Centro de Estudos em Terapias Inovadoras ? CETI

Curitiba, Paraná 80030-110

Brazil

Irmandade Da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul 90020-090

Brazil

Hospital de Clnicas de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

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

Botucatu, São Paulo 18618-686

Brazil

Centro de Pesquisa São Lucas

Campinas, São Paulo 13060-803

Brazil

HMCG - Hospital e Maternidade Dr. Christovo da Gama

Santo Andr, São Paulo 09030-010

Brazil

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

Sao Jose Rio Preto, São Paulo 15090-000

Brazil

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

Rio de Janeiro, 20241-180

Brazil

DermEffects

London, Ontario N6H 5L5

Canada

Lynderm Research Inc

Markham, Ontario L3P 1X3

Canada

DermEdge

Mississauga, Ontario L4Y4C5

Canada

Ryan Clinical Research Inc

Newmarket, Ontario L3Y 5G8

Canada

Fachklinik Bad Bentheim

Bad Bentheim, Lower Saxony 48455

Germany

Dermatologikum Hamburg Gemeinschaftspraxis GbR

Hamburg, 20354

Germany

Centrum Medyczne Pratia Katowice I

Katowice, Silesian Voivodeship 40-081

Poland

Centrum Medyczne Pratia Gdynia

Gdynia, 81-338

Poland

Specjalistyczny Gabinet Dermatologiczny dr n. med. Pawel Brzewski

Krakow, 30-002

Poland

Centrum Nowoczesnych Terapii "Dobry Lekarz"

Krakow, 31-011

Poland

Uniwersytecki Szpital Kliniczny im.Fryderyka Chopina w Rzeszowie

Rzeszów, 35-055

Poland

Klinika Ambroziak Dermatologia

Warsaw, 02-953

Poland

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain