A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT06691113
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Rhinosinusitis Without 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

ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 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 in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. Study details include: * The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks. * The intervention duration will be 24 weeks. * The number of visits will be 7 site visits and 8 phone/remote visits.

Key Dates

Start date
Dec 16, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2026
Completion
Aug 18, 2026

Study Design

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

Arms

  • Experimental: Itepekimab high dose
    Subcutaneous (SC) administration of Itepekimab high dose for 24 weeks
  • Experimental: Itepekimab low dose
    SC administration of Itepekimab low dose for 24 weeks
  • Placebo Comparator: Placebo
    SC administration of matching placebo for 24 weeks

Primary Outcome Measure

Change from baseline in sinus (maxillary, ethmoid) percent opacification volume assessed by CT scan [ Time Frame: Baseline to End of Treatment (EOT) (Week 24) ]

Locations (10)

FacilityCityStateZIPSite coordinators
Allervie Clinical Research - Birmingham- Site Number : 8400006BirminghamAlabama35209-
Modena Allergy + Asthma- Site Number : 8400005La JollaCalifornia92037-
United Medical Doctors - Murrieta- Site Number : 8400001MurrietaCalifornia92563-
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008RosevilleCalifornia95661-
Western States Clinical Research- Site Number : 8400009Wheat RidgeColorado80033-
Advanced Research Associates (ARA) Professionals- Site Number : 8400002MiamiFlorida33176-
Treasure Valley Medical Research- Site Number : 8400022BoiseIdaho83706-
ENT Associates of Texas - McKinne- Site Number : 8400013McKinneyTexas75070-
Alamo ENT Associates- Site Number : 8400026San AntonioTexas78258-
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400007NorfolkVirginia23510-

Find similar trials in Birmingham, AL

By research site
Allervie Clinical Research - Birmingham· Birmingham, ALModena Allergy + Asthma· La Jolla, CAUnited Medical Doctors - Murrieta· Murrieta, CASacramento Ear Nose & Throat - Roseville· Roseville, CAWestern States Clinical Research· Wheat Ridge, COAdvanced Research Associates (ARA) Professionals· Miami, FL

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