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
NCT ID: NCT06834360
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
210 participants
INTERVENTIONAL
2025-02-06
2027-12-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT06834347
A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti--IL-33 mAb) in Participants With Chronic Rhinosinusitis Without Nasal Polyps
NCT06691113
Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps
NCT02898454
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
NCT02912468
An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis
NCT01920893
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Itepekimab high dose
Subcutaneous (SC) administration of Itepekimab high dose for 52 weeks
Itepekimab (SAR440340)
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
Itepekimab low dose
SC administration of Itepekimab low dose for 52 weeks
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
Placebo
SC administration of matching placebo for 52 weeks
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
Exclusion Criteria
* Participants with a history of clinically significant renal, hepatic, metabolic, neurologic, hematologic, ophthalmologic, respiratory (excluding those with asthma and aspirin-exacerbated respiratory disease (AERD) which may be included in the study), gastrointestinal, cardiovascular, cerebrovascular, or other significant medical illness or disorder, which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study.
* Participants who are currently smoking tobacco and/or vaping, or participants in whom smoking/vaping cessation has occurred \<6 months prior to Screening (Visit 1). Nicotine replacement therapy and/or noninhaled tobacco product use are not considered current smoking of tobacco.
* Participants meet any contraindications for mometasone furoate nasal spray (MFNS) such as hypersensitivity to MFNS or any of its components; or participants with uncontrolled opportunistic infections.
* Participants with a history of a severe systemic hypersensitivity reaction to a mAb.
* Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint.
* Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc).
* Participants with severe uncontrolled asthma with history of 2 and/or more exacerbations, requiring SCS or 1 hospitalization requiring SCS in the past year.
* History of concomitant lung disease (other than asthma, eg, COPD, interstitial lung disease) which in the opinion of the Investigator could interfere with performance and interpretation of spirometry.
* Participants treated with intranasal corticosteroid(s) (INCS) (MFNS is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as XhanceTM during the screening period. In Japan and China INCS other than MFNS are permitted.
* Participants who have undergone any sinus intranasal surgery (including polypectomy) within 6 months before Visit 1.
* Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
* Known allergy to itepekimab or its excipients, or any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in this study.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Excel ENT of Alabama- Site Number : 8400052
Birmingham, Alabama, United States
Velocity Clinical Research - San Diego- Site Number : 8400041
La Mesa, California, United States
Cedars-Sinai Medical Center- Site Number : 8400030
Los Angeles, California, United States
North Bay Allergy & Asthma Associates- Site Number : 8400034
Napa, California, United States
University of Florida - Jacksonville- Site Number : 8400053
Jacksonville, Florida, United States
University of Miami Don Suffer Clinical Research Building- Site Number : 8400036
Miami, Florida, United States
Advanced Research Institute - New Port Richey- Site Number : 8400014
New Port Richey, Florida, United States
University of Illinois at Chicago- Site Number : 8400003
Chicago, Illinois, United States
Advanced ENT & Allergy - Louisville- Site Number : 8400007
Louisville, Kentucky, United States
Velocity Clinical Research - Lafayette- Site Number : 8400026
Lafayette, Louisiana, United States
Johns Hopkins Hospital- Site Number : 8400017
Baltimore, Maryland, United States
University of Cincinnati Medical Center- Site Number : 8400022
Cincinnati, Ohio, United States
Allergy, Asthma and Clinical Research- Site Number : 8400002
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Hospital- Site Number : 8400044
Philadelphia, Pennsylvania, United States
Spartanburg-Greer ENT & Allergy- Site Number : 8400039
Greer, South Carolina, United States
Ear and Sinus Institute- Site Number : 8400048
Fort Worth, Texas, United States
Investigational Site Number : 0320005
San Miguel de Tucumán, Tucumán Province, Argentina
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, Australia
Investigational Site Number : 0360002
Brisbane, Queensland, Australia
Investigational Site Number : 0360001
Spearwood, Western Australia, Australia
Investigational Site Number : 0560004
Gesves, Namur, Belgium
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, Brazil
Centro de Pesquisa Clínica de Marília - CPCLIM- Site Number : 0760002
Marília, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760005
São José do Rio Preto, São Paulo, Brazil
Clinica de Alergia Martti Antila- Site Number : 0760003
Sorocaba, São Paulo, Brazil
Investigational Site Number : 1240015
Cambridge, Ontario, Canada
Investigational Site Number : 1240014
Ottawa, Ontario, Canada
Investigational Site Number : 1240003
Québec, Quebec, Canada
Investigational Site Number : 1240012
Québec, Quebec, Canada
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Quillota, Región de Valparaíso, Chile
Investigational Site Number : 1520001
Concepción, Región del Biobío, Chile
Investigational Site Number : 1520004
Talcahuano, Región del Biobío, Chile
Investigational Site Number : 1560020
Baotou, , China
Investigational Site Number : 1560001
Beijing, , China
Investigational Site Number : 1560004
Chengdu, , China
Investigational Site Number : 1560025
Chongqing, , China
Investigational Site Number : 1560019
Hangzhou, , China
Investigational Site Number : 1560005
Hefei, , China
Investigational Site Number : 1560002
Jinan, , China
Investigational Site Number : 1560012
Jingzhou, , China
Investigational Site Number : 1560021
Nanning, , China
Investigational Site Number : 1560006
Shenyang, , China
Investigational Site Number : 1560024
Suzhou, , China
Investigational Site Number : 1560017
Taiyuan, , China
Investigational Site Number : 1560023
Taiyuan, , China
Investigational Site Number : 1560014
Wuhan, , China
Investigational Site Number : 1560003
Yantai, , China
Investigational Site Number : 1560009
Zibo, , China
Investigational Site Number : 2030002
Hradec Králové, , Czechia
Investigational Site Number : 2030003
Pardubice, , Czechia
Investigational Site Number : 2030005
Pilsen, , Czechia
Investigational Site Number : 2030004
Prague, , Czechia
Investigational Site Number : 2030001
Prague, , Czechia
Investigational Site Number : 2080001
Aarhus, , Denmark
Investigational Site Number : 2080004
Copenhagen, , Denmark
Investigational Site Number : 2080002
Køge, , Denmark
Investigational Site Number : 2500011
Bordeaux, , France
Investigational Site Number : 2500004
Marseille, , France
Investigational Site Number : 2500005
Montpellier, , France
Investigational Site Number : 2500001
Nantes, , France
Investigational Site Number : 2500010
Poitiers, , France
Investigational Site Number : 2500014
Pontoise, , France
Investigational Site Number : 2500007
Toulouse, , France
Investigational Site Number : 2760001
Dresden, , Germany
Investigational Site Number : 2760002
Leipzig, , Germany
Investigational Site Number : 3480005
Budapest, , Hungary
Investigational Site Number : 3480001
Szeged, , Hungary
Investigational Site Number : 3760003
Haifa, , Israel
Investigational Site Number : 3760004
Jerusalem, , Israel
Investigational Site Number : 3760001
Nahariya, , Israel
Investigational Site Number : 3760002
Rehovot, , Israel
Investigational Site Number : 3800001
Milan, Milano, Italy
Investigational Site Number : 3800005
Naples, Napoli, Italy
Investigational Site Number : 3800003
Catania, , Italy
Investigational Site Number : 5280002
Amsterdam, , Netherlands
Investigational Site Number : 5280001
Utrecht, , Netherlands
Investigational Site Number : 6160004
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160005
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160002
Lodz, Lódzkie, Poland
Investigational Site Number : 6160001
Bielsko-Biala, Silesian Voivodeship, Poland
Investigational Site Number : 6420003
Brasov, , Romania
Investigational Site Number : 6420001
Bucharest, , Romania
Investigational Site Number : 7240006
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
Santander, Cantabria, Spain
Investigational Site Number : 7240004
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Investigational Site Number : 7240008
Pamplona, Navarre, Spain
Investigational Site Number : 7240010
Madrid, , Spain
Investigational Site Number : 7240012
Madrid, , Spain
Investigational Site Number : 7920003
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920001
Bursa, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 8260002
Wigan, Lancashire, United Kingdom
Investigational Site Number : 8260001
London, London, City of, United Kingdom
Investigational Site Number : 8260003
Taunton, Somerset, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
Access external resources that provide additional context or updates about the study.
EFC18419 Plain Language Results Summary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-516815-26
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1306-6544
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC18419
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.