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 (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
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
California
Sensa Health- Site Number : 8400038
RECRUITING
Los Angeles
NewportNativeMD, Inc- Site Number : 8400031
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Newport Beach
Breathe Clear Institute for Sinus and Allergy Relief- Site Number : 8400040
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Torrance
Orso Health- Site Number : 8400035
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Torrance
Florida
ARA Professionals LLC- Site Number : 8400011
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Miami
Paradisus Med Research- Site Number : 8400009
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Miami
Orlando ENT & Allergy- Site Number : 8400008
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Orlando
Georgia
Emory University- Site Number : 8400047
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Atlanta
Illinois
University of Chicago- Site Number : 8400018
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Chicago
New York
North Shore University Hospital- Site Number : 8400028
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Great Neck
Texas
Ten20 Clinical Research- Site Number : 8400015
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Dallas
Virginia
Eastern Virginia Medical School (EVMS) Medical Group - Otola- Site Number : 8400046
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Norfolk
Other Locations
Argentina
Investigational Site Number : 0320001
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Ciudad Autonoma Buenos Aires
Investigational Site Number : 0320002
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La Plata
Investigational Site Number : 0320003
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Mendoza
Investigational Site Number : 0320004
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Rosario
Investigational Site Number : 0320005
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Vicente Lopez
Austria
Investigational Site Number : 0400005
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Graz
Investigational Site Number : 0400002
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Linz
Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS- Site Number : 0760002
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Ribeirão Preto
Canada
Investigational Site Number : 1240002
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Montreal
Investigational Site Number : 1240001
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Québec
Chile
Investigational Site Number : 1520001
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Santiago
Investigational Site Number : 1520002
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Santiago
Investigational Site Number : 1520004
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Santiago
Investigational Site Number : 1520003
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Talca
Investigational Site Number : 1520006
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Valdivia
Investigational Site Number : 1520005
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Viña Del Mar
Finland
Investigational Site Number : 2460003
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Helsinki
Investigational Site Number : 2460004
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Helsinki
Investigational Site Number : 2460002
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Kuopio
Germany
Investigational Site Number : 2760001
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Tübingen
Investigational Site Number : 2760005
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Wiesbaden
Investigational Site Number : 2760003
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Würzburg
Hungary
Investigational Site Number : 3480002
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Budapest
Investigational Site Number : 3480001
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Pécs
Israel
Investigational Site Number : 3760007
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Haifa
Investigational Site Number : 3760004
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Kfar Saba
Investigational Site Number : 3760005
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Petah Tikva
Investigational Site Number : 3760009
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Tel Aviv
Italy
Azienda Ospedaliero-Universitaria di Ferrara-Site Number: 3800004
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Cona (ferrara)
ASST Santi Paolo e Carlo-Presidio Ospedale San Paolo-Site Number : 3800006
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Milan
Azienda Ospedale - Università Padova-Site Number : 3800008
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Padua
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number: 3800002
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Roma
Japan
Investigational Site Number : 3920001
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Fukuoka
Investigational Site Number : 3920011
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Hiroshima
Investigational Site Number : 3920009
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Isehara
Investigational Site Number : 3920003
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Kumamoto
Investigational Site Number : 3920013
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Niigata
Investigational Site Number : 3920002
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Odawara-shi
Investigational Site Number : 3920014
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Yokohama
Investigational Site Number : 3920006
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Yoshida-gun
Netherlands
Investigational Site Number : 5280002
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Leiderdorp
Poland
Investigational Site Number : 6160003
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Bialystok
Investigational Site Number : 6160006
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Krakow
Investigational Site Number : 6160002
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Warsaw
Investigational Site Number : 6160001
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Wroclaw
Investigational Site Number : 6160004
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Wroclaw
Portugal
Investigational Site Number : 6200003
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Guimarães
Investigational Site Number : 6200004
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Matosinhos Municipality
Investigational Site Number : 6200002
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Porto
Investigational Site Number : 6200001
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Santa Maria Da Feira
Republic of Korea
Investigational Site Number : 4100005
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Cheonan
Investigational Site Number : 4100001
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Seoul
Investigational Site Number : 4100002
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Seoul
Investigational Site Number : 4100003
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Seoul
Investigational Site Number : 4100004
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Seoul
Spain
Investigational Site Number : 7240002
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Barcelona
Investigational Site Number : 7240004
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Jerez De La Frontera
Investigational Site Number : 7240001
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Majadahonda
Investigational Site Number : 7240003
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Santiago De Compostela
Investigational Site Number : 7240006
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Seville
Investigational Site Number : 7240005
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Zaragoza
Sweden
Investigational Site Number : 7520002
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Lund
Investigational Site Number : 7520001
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Stockholm
Investigational Site Number : 7520004
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Stockholm
Turkey
Investigational Site Number : 7920003
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Ankara
Investigational Site Number : 7920001
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Istanbul
Investigational Site Number : 7920002
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Istanbul
United Kingdom
Investigational Site Number : 8260004
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Bradford
Investigational Site Number : 8260002
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London
Investigational Site Number : 8260006
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Oxford
Investigational Site Number : 8260001
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Tyne And Wear
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-02-12
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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