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
Condition(s) studied
Investigational drug(s) / intervention(s)
Itepekimab (SAR440340): Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Placebo: Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous
Mometasone furoate nasal spray (MFNS): Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray
Study summary
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.
Eligibility
Primary outcome measure(s)
- Change from baseline in the endoscopic NPS — Baseline to Week 24
The Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Nasal polyp is graded based on polyp size from 0 to 4 with higher scores indicating larger polyps. The sum of right and left nostril scores ranges from 0 (no polyps) to 8 (large polyps). - Change from baseline in the NCS — Baseline to Week 24
The Nasal Congestion Score (NCS) is scored using a 0-3 categorical scale where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. Outcome value is defined as the preceding 28-day average of morning scores recorded in eDiary.
Trial sites (111)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Argentina | |
| Investigational Site Number : 0320001 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320004 | Corrientes | Argentina | |
| Investigational Site Number : 0320003 | Mendoza | Argentina | |
| 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 | Belgium | |
| Investigational Site Number : 0560002 | Ghent | Belgium | |
| Investigational Site Number : 0560001 | Leuven | Belgium | |
| Private Practice - Dr. Nelson Rosário- Site Number : 0760001 | Curitiba | Paraná | |
| Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002 | Marília | São Paulo | |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760005 | São José do Rio Preto | São Paulo | |
| Clinica de Alergia Martti Antila- Site Number : 0760003 | Sorocaba | São Paulo | |
| Investigational Site Number : 1240017 | Vancouver | British Columbia | |
| Investigational Site Number : 1240019 | Burlington | Ontario | |
| Investigational Site Number : 1240015 | Cambridge | Ontario | |
| Investigational Site Number : 1240014 | Ottawa | Ontario | |
| Investigational Site Number : 1240003 | Québec | Quebec | |
| Investigational Site Number : 1240012 | Québec | Quebec | |
| Investigational Site Number : 1520001 | Concepción | Biobio | |
| Investigational Site Number : 1520004 | Talcahuano | Biobio | |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago |
+ 71 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06834360 on ClinicalTrials.gov ↗ ← All trials in Italy