Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
3상
완료
NCT04607005
| 대상 질환 | Nasal Polyps |
|---|
| 임상 단계 | 3상 |
|---|
| 스폰서 | GlaxoSmithKline |
|---|
| 상태 | 완료 |
|---|
| 참여자 수 | 169 명 |
|---|
| 중재(약물) | Mepolizumab, Standard of care |
|---|
| 시작일 | 2021년 2월 8일 |
|---|
| 완료일 | 2023년 4월 12일 |
|---|
| 결과 공개일 | 2024년 11월 25일 |
|---|
요약
This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS for the purpose of registration in Japan and China. Approximately 160 participants will be randomized in a 1:1 ratio to receive either 100 mg SC mepolizumab or placebo SC. The study will include a 4-week run-in period followed by randomization to a 52-week treatment period, where participants will be administered 4-weekly doses of mepolizumab or placebo via a pre-filled safety syringe device (SSD) injection.
Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites
Baseline (Day 1) up to week 52 · Scores on a Scale
| Mepolizumab | -0.62 ± 0.164 Scores on a Scale |
|---|
| Placebo | -0.19 ± 0.164 Scores on a Scale |
|---|
| p-value | 0.067 |
|---|
| Mean Difference (Final Values) | -0.43 (95% CI -0.89–0.03) |
|---|
Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population
Baseline (Day 1) up to Week 52 · Scores on a Scale
| Mepolizumab | -0.65 ± 0.160 Scores on a Scale |
|---|
| Placebo | -0.19 ± 0.162 Scores on a Scale |
|---|
| p-value | 0.043 |
|---|
| Mean Difference (Final Values) | -0.47 (95% CI -0.92–-0.02) |
|---|
Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites
Baseline (Day 1) up to 4 weeks prior to week 52 · Scores on a Scale
| Mepolizumab | -3.23 ± 0.336 Scores on a Scale |
|---|
| Placebo | -1.80 ± 0.333 Scores on a Scale |
|---|
| p-value | 0.003 |
|---|
| Mean Difference (Final Values) | -1.43 (95% CI -2.37–-0.50) |
|---|
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.