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 (NCT06834347)
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)
EFC18418 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: University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037 — Arcadia, California
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 (121 Sites)
Showing the first 25 of 121 sites.
- University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037 — Arcadia, California
- Sensa Health- Site Number : 8400038 — Los Angeles, California
- Newport Native MD- Site Number : 8400031 — Newport Beach, California
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400064 — Roseville, California
- Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040 — Torrance, California
- Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035 — Torrance, California
- Advanced Research Associates (ARA) Professionals- Site Number : 8400011 — Miami, Florida
- Paradisus Med Research - Miami- Site Number : 8400009 — Miami, Florida
- Orlando ENT Associates - Orlando- Site Number : 8400008 — Orlando, Florida
- Emory University School of Medicine- Grady Campus- Site Number : 8400047 — Atlanta, Georgia
- Treasure Valley Medical Research- Site Number : 8400063 — Boise, Idaho
- University of Chicago Medical Center- Site Number : 8400018 — Chicago, Illinois
- Deaconess Clinic Allergy East- Site Number : 8400056 — Evansville, Indiana
- SSM Health Saint Louis University Hospital- Site Number : 8400005 — St Louis, Missouri
- Northwell Health Physician Partners Rheumatology at Great Neck- Site Number : 8400028 — Great Neck, New York
- Essential Medical Research- Site Number : 8400066 — Tulsa, Oklahoma
- TEN20 Clinical Research - Dallas- Site Number : 8400015 — Dallas, Texas
- Houston Methodist Hospital- Site Number : 8400054 — Houston, Texas
- ENT Associates of Texas - McKinne- Site Number : 8400062 — McKinney, Texas
- Alamo ENT Associates- Site Number : 8400065 — San Antonio, Texas
- Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046 — Norfolk, Virginia
- Investigational Site Number : 0320002 — La Plata, Buenos Aires
- Investigational Site Number : 0320004 — Rosario, Santa Fe Province
- Investigational Site Number : 0320001 — Buenos Aires,
- Investigational Site Number : 0320005 — Buenos Aires,
💰 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
- 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
- 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 — Birmingham, Alabama
- 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.