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
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.
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 (121)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Argentina | |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320003 | Mendoza | Argentina | |
| Investigational Site Number : 0400005 | Graz | Austria | |
| Investigational Site Number : 0400002 | Linz | Austria | |
| Investigational Site Number : 0400001 | Vienna | Austria | |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760002 | Ribeirão Preto | São Paulo | |
| Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760005 | São José dos Campos | São Paulo | |
| Hospital Israelita Albert Einstein- Site Number : 0760001 | São Paulo | Brazil | |
| Investigational Site Number : 1240005 | London | Ontario | |
| Investigational Site Number : 1240002 | Montreal | Quebec | |
| Investigational Site Number : 1240001 | Québec | Quebec | |
| Investigational Site Number : 1520006 | Valdivia | Los Ríos Region | |
| Investigational Site Number : 1520003 | Talca | Maule Region | |
| Investigational Site Number : 1520004 | Lo Barnechea | Reg Metropolitana de Santiago | |
| Investigational Site Number : 1520002 | Santiago | Reg Metropolitana de Santiago | |
| Investigational Site Number : 1520001 | Santiago | Reg Metropolitana de Santiago |
+ 81 more sites — see the full list on the official registry below.
More Sanofi trials in Poland
Other trials for the same condition
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 NCT06834347 on ClinicalTrials.gov ↗ ← All trials in Poland