CompletedPhase 3

Dupilumab in Chinese Adult Participants With CRSwNP

China63 participantsStarted 2023-05-16

Plain-language summary

This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy with intranasal corticosteroids (budesonide nasal spray). Study details include: * The study duration will be up to 40 weeks. * The treatment duration will be up to 24 weeks. * The number of visits will be 7.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. An endoscopic bilateral NPS at Visit 1 of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) as per central assessment
✓. Ongoing symptoms (for at least 8 weeks before Visit 1) of:

What they're measuring

Change From Baseline in Nasal Polyps Score at Week 24

Timeframe: Baseline (Day 1) and Week 24

Trial details

NCT IDNCT05878093

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-06

Results submitted2025-09-05

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps trials