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

Status: Recruiting
Location: See all (95) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must be 18 years of age or older.

• Participants with a history of chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 1 year prior to screening

• Participants must have at least one of the following features:

‣ Prior sinonasal surgery for nasal polyps (NP).

⁃ Worsening symptoms of chronic rhinosinusitis (CRS) requiring treatment with systemic corticosteroid(s) (SCS) within the prior 1 year before screening (Visit 1).

• An endoscopic bilateral Nasal Polyp Score (NPS) of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization.

• Ongoing symptoms (for at least 12 weeks before Visit 1) of:

‣ Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2), AND

⁃ At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).

• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:

‣ Is not a women of childbearing potential (WOCBP), OR

⁃ Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of \<1% during the study (at a minimum until 20 weeks after the last dose of study intervention).

Locations
United States
Alabama
Excel ENT of Alabama- Site Number : 8400052
RECRUITING
Birmingham
California
Velocity Clinical Research - San Diego- Site Number : 8400041
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La Mesa
Cedars-Sinai Medical Center- Site Number : 8400030
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Los Angeles
North Bay Allergy & Asthma Associates- Site Number : 8400034
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Napa
Florida
University of Florida - Jacksonville- Site Number : 8400053
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Jacksonville
University of Miami - 1150 NW 14th St- Site Number : 8400036
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Miami
Advanced Research Institute - New Port Richey- Site Number : 8400014
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New Port Richey
Illinois
University of Illinois at Chicago- Site Number : 8400003
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Chicago
Kentucky
Advanced ENT & Allergy - Louisville- Site Number : 8400007
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Louisville
Louisiana
Velocity Clinical Research - Lafayette- Site Number : 8400026
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Lafayette
Maryland
~Johns Hopkins University School of Medicine- Site Number : 8400017
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Baltimore
Ohio
University of Cincinnati Medical Center- Site Number : 8400022
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Cincinnati
Oklahoma
Allergy, Asthma and Clinical Research- Site Number : 8400002
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Oklahoma City
Pennsylvania
Thomas Jefferson University Hospital- Site Number : 8400044
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Philadelphia
South Carolina
Spartanburg-Greer ENT & Allergy- Site Number : 8400039
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Greer
Texas
Ear and Sinus Institute- Site Number : 8400048
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Fort Worth
Other Locations
Argentina
Investigational Site Number : 0320001
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Buenos Aires
Investigational Site Number : 0320002
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Buenos Aires
Investigational Site Number : 0320004
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Corrientes
Investigational Site Number : 0320003
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Mendoza
Investigational Site Number : 0320005
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San Miguel De Tucumán
Australia
Investigational Site Number : 0360003
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Bella Vista
Investigational Site Number : 0360002
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Brisbane
Investigational Site Number : 0360001
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Spearwood
Belgium
Investigational Site Number : 0560006
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Alken
Investigational Site Number : 0560004
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Gesves
Investigational Site Number : 0560002
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Ghent
Investigational Site Number : 0560001
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Leuven
Brazil
Private Practice - Dr. Nelson Rosário- Site Number : 0760001
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Curitiba
Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002
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Marília
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760005
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São José Do Rio Preto
Canada
Investigational Site Number : 1240015
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Cambridge
Investigational Site Number : 1240014
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Ottawa
Investigational Site Number : 1240003
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Québec
Investigational Site Number : 1240012
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Québec
Chile
Investigational Site Number : 1520001
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Concepción
Investigational Site Number : 1520002
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Quillota
Investigational Site Number : 1520003
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Santiago
Investigational Site Number : 1520004
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Talcahuano
China
Investigational Site Number : 1560020
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Baotou
Investigational Site Number : 1560001
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Beijing
Investigational Site Number : 1560004
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Chengdu
Investigational Site Number : 1560025
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Chongqing
Investigational Site Number : 1560019
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Hangzhou
Investigational Site Number : 1560005
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Hefei
Investigational Site Number : 1560002
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Jinan
Investigational Site Number : 1560012
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Jingzhou
Investigational Site Number : 1560021
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Nanning
Investigational Site Number : 1560006
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Shenyang
Investigational Site Number : 1560024
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Suzhou
Investigational Site Number : 1560017
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Taiyuan
Investigational Site Number : 1560023
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Taiyuan
Investigational Site Number : 1560014
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Wuhan
Investigational Site Number : 1560003
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Yantai
Investigational Site Number : 1560009
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Zibo
Denmark
Investigational Site Number : 2080001
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Aarhus
Investigational Site Number : 2080004
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Copenhagen
Investigational Site Number : 2080002
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Køge
France
Investigational Site Number : 2500011
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Bordeaux
Investigational Site Number : 2500004
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Marseille
Investigational Site Number : 2500005
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Montpellier
Investigational Site Number : 2500001
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Nantes
Investigational Site Number : 2500010
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Poitiers
Investigational Site Number : 2500014
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Pontoise
Investigational Site Number : 2500007
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Toulouse
Germany
Investigational Site Number : 2760001
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Dresden
Investigational Site Number : 2760002
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Leipzig
Hungary
Investigational Site Number : 3480005
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Budapest
Investigational Site Number : 3480001
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Szeged
Israel
Investigational Site Number : 3760003
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Haifa
Investigational Site Number : 3760004
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Jerusalem
Investigational Site Number : 3760001
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Nahariya
Investigational Site Number : 3760002
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Rehovot
Italy
Investigational Site Number : 3800003
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Catania
Investigational Site Number : 3800001
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Milan
Investigational Site Number : 3800005
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Naples
Netherlands
Investigational Site Number : 5280002
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Amsterdam
Poland
Investigational Site Number : 6160001
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Bielsko-biala
Investigational Site Number : 6160002
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Lodz
Investigational Site Number : 6160004
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Poznan
Investigational Site Number : 6160005
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Wroclaw
Romania
Investigational Site Number : 6420003
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Brasov
Investigational Site Number : 6420001
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Bucharest
Spain
Investigational Site Number : 7240006
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Barcelona
Investigational Site Number : 7240004
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L'hospitalet De Llobregat
Investigational Site Number : 7240010
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Madrid
Investigational Site Number : 7240012
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Madrid
Investigational Site Number : 7240008
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Pamplona
Investigational Site Number : 7240002
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Santander
Turkey
Investigational Site Number : 7920003
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Ankara
Investigational Site Number : 7920001
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Bursa
Investigational Site Number : 7920002
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Istanbul
United Kingdom
Investigational Site Number : 8260001
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London
Investigational Site Number : 8260003
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Taunton
Investigational Site Number : 8260002
RECRUITING
Wigan
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-02-06
Estimated Completion Date: 2027-12-13
Participants
Target number of participants: 210
Treatments
Experimental: Itepekimab high dose
Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks
Experimental: Itepekimab low dose
SC administration of Itepekimab low dose for 52 weeks
Placebo_comparator: Placebo
SC administration of matching placebo for 52 weeks
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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