BENITIONSClinical Trial Intelligence

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

第2相 完了 NCT05018806

対象疾患Atopic Dermatitis
第2相
スポンサーSanofi
ステータス完了
参加者数124 名
介入(薬剤)Rilzabrutinib
開始日2021年9月9日
完了日2023年6月23日
結果公開日2026年7月13日

概要

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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このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。