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 (NCT06834360)
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Itepekimab in Adult Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Excel ENT of Alabama- Site Number : 8400052 — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (111 Sites)
Showing the first 25 of 111 sites.
- Excel ENT of Alabama- Site Number : 8400052 — Birmingham, Alabama
- Velocity Clinical Research - San Diego- Site Number : 8400041 — La Mesa, California
- Cedars-Sinai Medical Center- Site Number : 8400030 — Los Angeles, California
- One Of A Kind Clinical Research Center- Site Number : 8400034 — Napa, California
- University of Florida - Jacksonville- Site Number : 8400053 — Jacksonville, Florida
- Advanced Research Institute - New Port Richey- Site Number : 8400014 — New Port Richey, Florida
- University of Illinois at Chicago- Site Number : 8400003 — Chicago, Illinois
- Advanced ENT & Allergy - Louisville- Site Number : 8400007 — Louisville, Kentucky
- Velocity Clinical Research - Lafayette- Site Number : 8400026 — Lafayette, Louisiana
- Johns Hopkins Hospital- Site Number : 8400017 — Baltimore, Maryland
- University of Cincinnati Medical Center- Site Number : 8400022 — Cincinnati, Ohio
- Allergy, Asthma and Clinical Research- Site Number : 8400002 — Oklahoma City, Oklahoma
- Thomas Jefferson University Hospital- Site Number : 8400044 — Philadelphia, Pennsylvania
- Spartanburg-Greer ENT & Allergy- Site Number : 8400039 — Greer, South Carolina
- Ear and Sinus Institute- Site Number : 8400048 — Fort Worth, Texas
- Investigational Site Number : 0320005 — San Miguel de Tucumán, Tucumán Province
- Investigational Site Number : 0320002 — Buenos Aires,
- Investigational Site Number : 0320001 — Buenos Aires,
- Investigational Site Number : 0320004 — Corrientes,
- Investigational Site Number : 0320003 — Mendoza,
- Investigational Site Number : 0360003 — Bella Vista, New South Wales
- Investigational Site Number : 0360002 — Brisbane, Queensland
- Investigational Site Number : 0360001 — Spearwood, Western Australia
- Investigational Site Number : 0560004 — Gesves, Namur
- Investigational Site Number : 0560006 — Alken,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Rhinosinusitis With Nasal Polyps
- 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 — Arcadia, California
- An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps — La Mesa, California
- A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab — Newport Beach, California
- Effect of Celecoxib on Postoperative Analgesia and Disease Severity in AERD Patients with CRS — London, Ontario
- Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis — London, Ontario
Explore by condition: All Chronic Rhinosinusitis With Nasal Polyps clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.