drugset / Trial / NCT05018806

Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis

NCT05018806

Phase 2 Completed 124 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This was a parallel treatment, Phase 2, double-blind, 2-arm, placebo-controlled study with 2 staggered cohorts (2 arms in each cohort) to evaluate the efficacy and safety of rilzabrutinib in adult participants (aged at least 18 years) with moderate-to-severe AD and intolerance or inadequate response to topical corticosteroids (TCS). The total study duration per participant was expected to be approximately 21 weeks, including up to 4 weeks of screening, 16 weeks of on-treatment double-blind period, 1 week of post-treatment follow-up.

Timeline

Start
2021-09-09
Primary completion
2023-06-23
Completion
2023-06-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilzabrutinib Small molecule 400 mg Oral

Indications