Dupilumab in Chinese Adult Participants With CRSwNP

Sponsor
Sanofi
Study ID
NCT05878093
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    solution for subcutaneous injection
  • Placebo — DRUG
    solution for subcutaneous injection
  • Budesonide — DRUG
    nasal spray (suspension)

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Sep 2025
Primary completion
Sep 6, 2024
Completion
Nov 28, 2024

Study Design

Enrollment
63 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Dupilumab every 2 weeks (Q2W) via SC injection
  • Placebo Comparator: Placebo
    Placebo matching dupilumab Q2W via SC injection

Primary Outcome Measure

Change From Baseline in Nasal Polyps Score at Week 24 [ Time Frame: Baseline (Day 1) and Week 24 ]

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