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An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps
Sponsor: Sanofi
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2026-03-12
Completion Date
2027-02-17
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
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
Locations (46)
Velocity Clinical Research - San Diego- Site Number : 8402041
La Mesa, California, United States
Allergy, Asthma and Clinical Research- Site Number : 8402002
Oklahoma City, Oklahoma, United States
Ear and Sinus Institute- Site Number : 8402048
Fort Worth, Texas, United States
Investigational Site Number : 0321004
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0321001
Buenos Aires, Argentina
Investigational Site Number : 0321003
Mendoza, Argentina
Investigational Site Number : 0362001
Spearwood, Western Australia, Australia
Investigational Site Number : 0401005
Graz, Austria
Investigational Site Number : 1241001
Québec, Quebec, Canada
Investigational Site Number : 1242003
Québec, Quebec, Canada
Investigational Site Number : 1242012
Québec, Quebec, Canada
Investigational Site Number : 1522001
Concepción, Biobio, Chile
Investigational Site Number : 1521003
Talca, Maule Region, Chile
Investigational Site Number : 1521004
Lo Barnechea, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1521001
Puente Alto, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1522003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1521002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1562012
Baotou, China
Investigational Site Number : 1562001
Beijing, China
Investigational Site Number : 1562004
Chengdu, China
Investigational Site Number : 1562002
Jinan, China
Investigational Site Number : 1562008
Jingzhou, China
Investigational Site Number : 1562013
Nanning, China
Investigational Site Number : 1562006
Shenyang, China
Investigational Site Number : 1562010
Taiyuan, China
Investigational Site Number : 1562014
Taiyuan, China
Investigational Site Number : 1562009
Wuhan, China
Investigational Site Number : 1562007
Zibo, China
Investigational Site Number : 2032002
Hradec Králové, Czechia
Investigational Site Number : 2032003
Pardubice, Czechia
Investigational Site Number : 2032004
Prague, Czechia
Investigational Site Number : 2032001
Prague, Czechia
Investigational Site Number : 3482005
Budapest, Hungary
Investigational Site Number : 3481002
Budapest, Hungary
Investigational Site Number : 3481001
Pécs, Hungary
Investigational Site Number : 6162004
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6161004
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6162001
Bielsko-Biala, Silesian Voivodeship, Poland
Investigational Site Number : 6201003
Guimarães, Portugal
Investigational Site Number : 6201002
Porto, Portugal
Investigational Site Number : 4101003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4101002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4101001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 8262002
Wigan, Lancashire, United Kingdom
Investigational Site Number : 8262001
London, London, City of, United Kingdom
Investigational Site Number : 8261004
Bradford, United Kingdom