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
Not Yet Recruiting

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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

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

Study Design

Enrollment
20 participants (estimated)
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 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

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