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 Italy 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

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)

Percentage of Participants with Adverse Events — From Baseline up to 6 years

Trial sites (29)

Facility	City	Region	Status
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

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Other trials for the same condition

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting

This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment Recruiting

A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis Active, not recruiting

A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis Recruiting

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis 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 Italy