A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps

Sponsor
Sanofi
Study ID
NCT07484230
Phase
PHASE3
Status
Withdrawn

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

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

Interventions

  • Itepekimab (SAR440340) — DRUG
    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

Study Details

This is a randomized, multicenter, double-blind, Phase 3 study with 2 parallel groups. The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different dosing regimens of itepekimab monotherapy in Japanese participants aged 18 years or older with chronic rhinosinusitis with nasal polyp(s) (CRSwNP) who are not adequately controlled despite previous surgery and/or treatment with systemic corticosteroid(s) (SCS). The total study duration par participant is approximately 76 week, including: * A screening period for up to 4 weeks. * A randomized study intervention period for up to 52 weeks * A post-intervention safety follow-up for up to 20 weeks * The number of visits will be 9 site visits and 20 phone/home visits

Key Dates

First listed
Mar 20, 2026
Start date
May 8, 2026
Status verified
Aug 2026
Primary completion
Oct 20, 2027
Completion
Oct 10, 2028

Study Design

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

Arms

  • Experimental: Itepekimab high dose
    Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks
  • Experimental: Itepekimab low dose
    SC administration of Itepekimab low dose for 52 weeks

Primary Outcome Measure

Change from baseline in the endoscopic NPS [ Time Frame: Baseline to Week 24 ]

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