BENITIONSClinical Trial Intelligence

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

Фаза 2 Завершено NCT05018806

ЗаболеваниеAtopic Dermatitis
ФазаФаза 2
СпонсорSanofi
СтатусЗавершено
Участники124 участн.
ВмешательствоRilzabrutinib
Дата начала9.09.2021
Дата завершения23.06.2023
Публикация результатов13.07.2026

Кратко

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)

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