BENITIONSClinical Trial Intelligence

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

Phase 2 Completed NCT05018806

ConditionAtopic Dermatitis
PhasePhase 2
SponsorSanofi
StatusCompleted
Enrollment124 participants
InterventionsRilzabrutinib
Start dateSep 9, 2021
Completion dateJun 23, 2023
Results postedJul 13, 2026

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.

Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score

Baseline (Day 1) to Week 16 · Percent change

BID Cohort: Placebo-47.33 ± 9.77 Percent change
BID Cohort: Rilzabrutinib-53.57 ± 8.25 Percent change
TID Cohort: Placebo-43.33 ± 6.99 Percent change
TID Cohort: Rilzabrutinib-47.21 ± 6.26 Percent change
p-value0.6246
Least Square Mean Difference-6.25 (95% CI -31.26–18.77)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.