A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT06280391
Phase
PHASE2
Status
Completed

Conditions

  • Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Itepekimab (SAR440340) — DRUG
    Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Study Details

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.

Key Dates

Start date
Feb 20, 2024
Status verified
Feb 2026
Primary completion
Sep 16, 2025
Completion
Feb 2, 2026

Study Design

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

Arms

  • Experimental: Itepekimab Q2W
    Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
  • Experimental: Itepekimab Q4W
    SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks
  • Placebo Comparator: Placebo
    SC administration of matching placebo Q2W for up to 52 weeks

Primary Outcome Measure

Annualized rate of moderate or severe Pulmonary exacerbations (PEs) over the treatment period [ Time Frame: Baseline up to End of Treatment (EOT) (24-52 weeks) ]

Locations (32)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham- Site Number : 8400040BirminghamAlabama35233-
Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012PhoenixArizona85006-
Southern California Institute for Respiratory Diseases- Site Number : 8400002Los AngelesCalifornia90048-
Institute Healthcare Assessment- Site Number : 8400037San DiegoCalifornia92120-
Allianz Research Institute- Site Number : 8400013WestminsterCalifornia92683-
Allianz Research Institute CO- Site Number : 8400038AuroraColorado80014-
University of Connecticut Health Center- Site Number : 8400020FarmingtonConnecticut06032-
Yale New Haven Hospital- Site Number : 8400065New HavenConnecticut06510-
Advanced Pulmonary Research Institute- Site Number : 8400007Loxahatchee GrovesFlorida33470-
Clever Medical Research- Site Number : 8400001MiamiFlorida33126-
High Quality Research- Site Number : 8400047MiamiFlorida33184-
My Community Research Center- Site Number : 8400023MiamiFlorida33155-
Destiny Research Center- Site Number : 8400049Palmetto BayFlorida33157-
Avanza Medical Research Center- Site Number : 8400018PensacolaFlorida32503-
Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400010PlantationFlorida33324-
Northwestern Memorial Hospital- Site Number : 8400043ChicagoIllinois60611-
University of Kansas Medical Center- Site Number : 8400045Kansas CityKansas66160-
University of Michigan Health System - Ann Arbor- Site Number : 8400055Ann ArborMichigan48109-
Pulmonary and Medicine Associates- Site Number : 8400057WarrenMichigan48088-
Washington University- Site Number : 8400046St LouisMissouri63110-
NYU Langone Medical Center- Site Number : 8400032New YorkNew York10016-
American Health Research - Charlotte- Site Number : 8400017CharlotteNorth Carolina28277-
Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400009HuntersvilleNorth Carolina28078-
Southeastern Research Center- Site Number : 8400008Winston-SalemNorth Carolina27103-
Clinical Research Associates of Central PA - Dubois- Site Number : 8400005DuBoisPennsylvania15801-
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400039PhiladelphiaPennsylvania19104-
Temple University Hospital- Site Number : 8400015PhiladelphiaPennsylvania19140-
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400027CharlestonSouth Carolina29425-
Metroplex Pulmonary and Sleep Center- Site Number : 8400014McKinneyTexas75069-
Plano Primary Care Clinic- Site Number : 8400019PlanoTexas75024-
Pioneer Research Solutions, Inc.- Site Number : 8400048Sugar LandTexas77479-
The University of Texas Health Center at Tyler- Site Number : 8400053TylerTexas75708-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALPulmonary Associates - Phoenix - East McDowell Road· Phoenix, AZSouthern California Institute for Respiratory Diseases· Los Angeles, CAInstitute Healthcare Assessment· San Diego, CAAllianz Research Institute· Westminster, CAAllianz Research Institute CO· Aurora, CO

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