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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT06834360
Phase
PHASE3
Status
Active Not Recruiting

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
  • Mometasone furoate nasal spray (MFNS) — DRUG
    Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Study Details

EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older. Study details include: * The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks. * The treatment duration will be up to 52 weeks. * The number of visits will be 9 site visits and 20 phone/home visits.

Key Dates

Start date
Feb 6, 2025
Status verified
Jun 2026
Primary completion
Nov 6, 2026
Completion
Oct 11, 2027

Study Design

Enrollment
216 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
  • Placebo Comparator: Placebo
    SC administration of matching placebo for 52 weeks

Primary Outcome Measure

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

Locations (15)

FacilityCityStateZIPSite coordinators
Excel ENT of Alabama- Site Number : 8400052BirminghamAlabama35244-
Velocity Clinical Research - San Diego- Site Number : 8400041La MesaCalifornia91942-
Cedars-Sinai Medical Center- Site Number : 8400030Los AngelesCalifornia90048-
One Of A Kind Clinical Research Center- Site Number : 8400034NapaCalifornia94558-
University of Florida - Jacksonville- Site Number : 8400053JacksonvilleFlorida32209-
Advanced Research Institute - New Port Richey- Site Number : 8400014New Port RicheyFlorida34653-
University of Illinois at Chicago- Site Number : 8400003ChicagoIllinois60607-
Advanced ENT & Allergy - Louisville- Site Number : 8400007LouisvilleKentucky40220-
Velocity Clinical Research - Lafayette- Site Number : 8400026LafayetteLouisiana70508-
Johns Hopkins Hospital- Site Number : 8400017BaltimoreMaryland21287-
University of Cincinnati Medical Center- Site Number : 8400022CincinnatiOhio45219-
Allergy, Asthma and Clinical Research- Site Number : 8400002Oklahoma CityOklahoma73120-
Thomas Jefferson University Hospital- Site Number : 8400044PhiladelphiaPennsylvania19107-
Spartanburg-Greer ENT & Allergy- Site Number : 8400039GreerSouth Carolina29650-
Ear and Sinus Institute- Site Number : 8400048Fort WorthTexas76104-

Find similar trials in Birmingham, AL

By research site
Excel ENT of Alabama· Birmingham, ALVelocity Clinical Research - San Diego· La Mesa, CACedars-Sinai Medical Center· Los Angeles, CAOne Of A Kind Clinical Research Center· Napa, CAUniversity of Florida - Jacksonville· Jacksonville, FLAdvanced Research Institute - New Port Richey· New Port Richey, FL

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