NCT05018806

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

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Proof-of-concept Study Evaluating Efficacy and Safety of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Who Are Inadequate Responders or Intolerant to Topical Corticosteroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Placebo	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Rilzabrutinib	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2021-09-09
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2021-08-24
• Last updated: 2024-06-21

Locations

31 sites across 7 countries: United States, Canada, Chile, Czechia, Germany, Netherlands, Poland

Regulatory

• FDA-regulated drug study