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

NCT07223697

RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Atopic Dermatitis

Interventions: Afimkibart

Countries: United States, Brazil, Canada, Germany, Italy, Poland, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (28)
  • Los Angeles, California, United States
  • Tampa, Florida, United States
  • Alpharetta, Georgia, United States
  • Troy, Michigan, United States
  • Camp Hill, Pennsylvania, United States
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Botucatu, São Paulo, Brazil
  • Campinas, São Paulo, Brazil
  • Santo Andr, São Paulo, Brazil
  • Sao Jose Rio Preto, São Paulo, Brazil
  • Rio de Janeiro, Brazil
  • London, Ontario, Canada
  • Markham, Ontario, Canada
  • Mississauga, Ontario, Canada
  • Newmarket, Ontario, Canada
  • Bad Bentheim, Lower Saxony, Germany
  • Hamburg, Germany
  • Ancona, The Marches, Italy
  • Katowice, Silesian Voivodeship, Poland
  • Gdynia, Poland
  • Krakow, Poland
  • Krakow, Poland
  • Rzeszów, Poland
  • Warsaw, Poland
  • Pamplona, Navarre, Spain
  • Córdoba, Spain