An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps

Part of paid clinical trials in La Mesa, California.

Sponsor
Sanofi
Study ID
NCT07424144
Phase
PHASE3
Status
Enrolling By Invitation

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 double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both new or continued treatment with itepekimab 300 mg SC high dose or itepekimab 300 mg SC low dose in participants with CRSwNP having completed the intervention period of the clinical studies EFC18418 or EFC18419. A secondary purpose of this study is to provide efficacy outcomes beyond the intervention period of the parent trials EFC18418 and EFC18419. Study details include: * The study duration will be up to 72 weeks. * The intervention duration will be 52 weeks. * A follow-up period of 20 weeks will be conducted. * The number of visits will be 8 and the number of phone contacts will be 4.

Key Dates

Start date
Mar 12, 2026
Status verified
May 2026
Primary completion
Dec 12, 2028
Completion
Dec 12, 2028

Study Design

Enrollment
380 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

Incidence of treatment-emergent adverse events (AEs), adverse events of special interest (AESIs), serious adverse events (SAEs), AEs leading to death, and AEs leading to permanent treatment discontinuation [ Time Frame: Baseline to EOS (Week 72) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research - San Diego- Site Number : 8402041La MesaCalifornia91942-
Allergy, Asthma and Clinical Research- Site Number : 8402002Oklahoma CityOklahoma73120-

Find similar trials in La Mesa, CA

By research site
Velocity Clinical Research - San Diego· La Mesa, CAAllergy, Asthma and Clinical Research· Oklahoma City, OK

Related Studies