Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
Фаза 3
Завершено
NCT04607005
| Заболевание | Nasal Polyps |
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| Фаза | Фаза 3 |
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| Спонсор | GlaxoSmithKline |
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| Статус | Завершено |
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| Участники | 169 участн. |
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| Вмешательство | Mepolizumab, Standard of care |
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| Дата начала | 8.02.2021 |
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| Дата завершения | 12.04.2023 |
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| Публикация результатов | 25.11.2024 |
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Кратко
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 |
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| Placebo | -0.19 ± 0.164 Scores on a Scale |
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| p-value | 0.067 |
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| Mean Difference (Final Values) | -0.43 (95% CI -0.89–0.03) |
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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 |
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| Placebo | -0.19 ± 0.162 Scores on a Scale |
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| p-value | 0.043 |
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| Mean Difference (Final Values) | -0.47 (95% CI -0.92–-0.02) |
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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 |
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| Placebo | -1.80 ± 0.333 Scores on a Scale |
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| p-value | 0.003 |
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| Mean Difference (Final Values) | -1.43 (95% CI -2.37–-0.50) |
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