BENITIONSClinical Trial Intelligence

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

2期 已完成 NCT05018806

适应症Atopic Dermatitis
分期2期
申办方Sanofi
状态已完成
受试者人数124 人
干预(药物)Rilzabrutinib
开始日期2021年9月9日
完成日期2023年6月23日
结果公布日2026年7月13日

摘要

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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。