An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (NCT07424144)
A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Participated in Either EFC18418 or EFC18419 Clinical Studies
🩺 Plain-English Summary (8th-Grade Level)
This is a double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both new or continued treatment with itepekimab 300 mg SC high dose or itepekimab 300 mg SC low dose in participants with CRSwNP having completed the intervention period of the clinical studies EFC18418 or EFC18419. A secondary purpose of this study is to provide efficacy outcomes beyond the intervention period of the parent trials EFC18418 and EFC18419. Study details include: * The study duration will be up to 72 weeks. * The intervention duration will be 52 weeks. * A follow-up period of 20 weeks will be conducted. * The number of visits will be 8 and the number of phone contacts will be 4.
Who can join: Review the eligibility criteria below.
Location: Velocity Clinical Research - San Diego- Site Number : 8402041 — La Mesa, 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 (23 Sites)
- Velocity Clinical Research - San Diego- Site Number : 8402041 — La Mesa, California
- Allergy, Asthma and Clinical Research- Site Number : 8402002 — Oklahoma City, Oklahoma
- Investigational Site Number : 0362001 — Spearwood, Western Australia
- Investigational Site Number : 1241001 — Québec, Quebec
- Investigational Site Number : 1242003 — Québec, Quebec
- Investigational Site Number : 1242012 — Québec, Quebec
- Investigational Site Number : 1522001 — Concepción, Biobio
- Investigational Site Number : 1521003 — Talca, Maule Region
- Investigational Site Number : 1522003 — Santiago, Reg Metropolitana de Santiago
- Investigational Site Number : 1521002 — Santiago, Reg Metropolitana de Santiago
- Investigational Site Number : 1521001 — Santiago, Reg Metropolitana de Santiago
- Investigational Site Number : 1562012 — Baotou,
- Investigational Site Number : 1562001 — Beijing,
- Investigational Site Number : 1562004 — Chengdu,
- Investigational Site Number : 1562008 — Jingzhou,
- Investigational Site Number : 1562006 — Shenyang,
- Investigational Site Number : 1562010 — Taiyuan,
- Investigational Site Number : 2032001 — Prague,
- Investigational Site Number : 3481002 — Budapest,
- Investigational Site Number : 4101003 — Seoul, Seoul-teukbyeolsi
- Investigational Site Number : 4101001 — Seoul, Seoul-teukbyeolsi
- Investigational Site Number : 8262002 — Wigan, Lancashire
- Investigational Site Number : 8261004 — Bradford,
💰 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
- 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.