Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)

Sponsor
Sanofi
Study ID
NCT05049122
Phase
PHASE4
Status
Completed

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

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

Interventions

  • Dupilumab SAR231893 — DRUG
    Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)

Study Details

This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately controlled with existing therapies. Duration of study period (per participant): * Screening Period (2 to 4 weeks) * Intervention Period (up to 52 weeks±3 days)

Key Dates

First listed
Sep 17, 2021
Start date
Oct 22, 2021
Status verified
Sep 2025
Primary completion
Dec 21, 2022
Completion
Jul 5, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Dupilumab every 2 weeks (q2w). Dosing interval may be changed from q2w to q4w at week 24

Primary Outcome Measure

Percentage of Participants With NPS Improvement From Baseline >=1 at Week 24 [ Time Frame: Baseline (Day 1) and Week 24 ]

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