A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Part… (NCT07223697) | Clinical Trial Compass
RecruitingPhase 2
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis
United States, Brazil120 participantsStarted 2026-01-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Percentage of Participants with Adverse Events
Timeframe: From Baseline up to 6 years
Trial details
NCT IDNCT07223697
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2033-03-01
Contact for this trial
Reference Study ID Number: CS45943 https://forpatients.roche.com/