Not currently recruiting at University of California Health

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

a study on Atopic Dermatitis (Eczema)

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

Official Title

An Extension Study To Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients With Atopic Dermatitis Who Participated in Previous Afimkibart Clinical Trials

Keywords

Atopic Dermatitis, Afimkibart

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Division of Dermatology in progress, not accepting new patients
    Los Angeles California 90024 United States
  • Dermatology Research Associate in progress, not accepting new patients
    Los Angeles California 90045 United States
  • University of Minnesota accepting new patients
    Minneapolis Minnesota 55455 United States
  • Centro de Estudos em Terapias Inovadoras ? CETI accepting new patients
    Curitiba Paraná 80030-110 Brazil
  • Irmandade Da Santa Casa de Misericordia de Porto Alegre in progress, not accepting new patients
    Porto Alegre Rio Grande do Sul 90020-090 Brazil
  • Hospital de Clnicas de Porto Alegre in progress, not accepting new patients
    Porto Alegre Rio Grande do Sul 90035-903 Brazil
  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu in progress, not accepting new patients
    Botucatu São Paulo 18618-686 Brazil
  • Centro de Pesquisa São Lucas in progress, not accepting new patients
    Campinas São Paulo 13060-803 Brazil
  • HMCG - Hospital e Maternidade Dr. Christovo da Gama accepting new patients
    Santo Andr São Paulo 09030-010 Brazil
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS in progress, not accepting new patients
    Sao Jose Rio Preto São Paulo 15090-000 Brazil

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
Links
Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.
ID
NCT07223697
Phase
Phase 2 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated