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: NCT06834347
Last Updated: 2025-11-10
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
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RECRUITING
PHASE3
210 participants
INTERVENTIONAL
2025-02-12
2027-12-13
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
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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
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Eligibility Criteria
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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
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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University of Southern California (USC) / Keck Medicine of USC- Site Number : 8400037
Arcadia, California, United States
Sensa Health- Site Number : 8400038
Los Angeles, California, United States
Newport Native MD- Site Number : 8400031
Newport Beach, California, United States
Breathe Clear Institute of Sinus and Allergy Relief- Site Number : 8400040
Torrance, California, United States
Orso Health - Torrance - Hawthorne Boulevard- Site Number : 8400035
Torrance, California, United States
Advanced Research Associates (ARA) Professionals- Site Number : 8400011
Miami, Florida, United States
Paradisus Med Research - Miami- Site Number : 8400009
Miami, Florida, United States
Orlando ENT Associates - Orlando- Site Number : 8400008
Orlando, Florida, United States
Emory University School of Medicine- Grady Campus- Site Number : 8400047
Atlanta, Georgia, United States
University of Chicago Medical Center- Site Number : 8400018
Chicago, Illinois, United States
Northwell Health Physician Partners Rheumatology at Great Neck- Site Number : 8400028
Great Neck, New York, United States
TEN20 Clinical Research - Dallas- Site Number : 8400015
Dallas, Texas, United States
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400046
Norfolk, Virginia, United States
Investigational Site Number : 0320002
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320004
Rosario, Santa Fe Province, Argentina
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, Brazil
Centro Internacional de Pesquisa Clínica (CIPES)- Site Number : 0760005
São José dos Campos, São Paulo, Brazil
Investigational Site Number : 1240005
London, Ontario, Canada
Investigational Site Number : 1240002
Montreal, Quebec, Canada
Investigational Site Number : 1240001
Québec, Quebec, Canada
Investigational Site Number : 1520006
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520003
Talca, Maule Region, Chile
Investigational Site Number : 1520004
Lo Barnechea, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Viña del Mar, Región de Valparaíso, Chile
Investigational Site Number : 2460003
Helsinki, , Finland
Investigational Site Number : 2460004
Helsinki, , Finland
Investigational Site Number : 2460002
Kuopio, , Finland
Investigational Site Number : 2760004
Berlin, , Germany
Investigational Site Number : 2760001
Tübingen, , Germany
Investigational Site Number : 2760005
Wiesbaden, , Germany
Investigational Site Number : 2760003
Würzburg, , Germany
Investigational Site Number : 3480002
Budapest, , Hungary
Investigational Site Number : 3480003
Nyíregyháza, , Hungary
Investigational Site Number : 3480001
Pécs, , Hungary
Investigational Site Number : 3760007
Haifa, , Israel
Investigational Site Number : 3760004
Kefar Sava, , Israel
Investigational Site Number : 3760005
Petah Tikva, , Israel
Investigational Site Number : 3760009
Tel Aviv, , Israel
Azienda Ospedaliero-Universitaria di Ferrara-Site Number: 3800004
Cona, Ferrara, Italy
ASST Santi Paolo e Carlo-Presidio Ospedale San Paolo-Site Number : 3800006
Milan, Milano, Italy
Azienda Ospedale - Università Padova-Site Number : 3800008
Padua, Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number: 3800002
Rome, Roma, Italy
Investigational Site Number : 3920010
Ichikawa-shi, Chiba, Japan
Investigational Site Number : 3920009
Isehara, Kanagawa, Japan
Investigational Site Number : 3920002
Odawara, Kanagawa, Japan
Investigational Site Number : 3920014
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920005
Suwa, Nagano, Japan
Investigational Site Number : 3920012
Kusatsu, Shiga, Japan
Investigational Site Number : 3920006
Fukui, , Japan
Investigational Site Number : 3920001
Fukuoka, , Japan
Investigational Site Number : 3920011
Hiroshima, , Japan
Investigational Site Number : 3920003
Kumamoto, , Japan
Investigational Site Number : 3920013
Niigata, , Japan
Investigational Site Number : 5280004
Alkmaar, , Netherlands
Investigational Site Number : 5280002
Leiderdorp, , Netherlands
Investigational Site Number : 6160006
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160001
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160004
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number : 6160005
Lublin, Lublin Voivodeship, Poland
Investigational Site Number : 6160002
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160003
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6200003
Guimarães, , Portugal
Investigational Site Number : 6200004
Matosinhos Municipality, , Portugal
Investigational Site Number : 6200002
Porto, , Portugal
Investigational Site Number : 6200001
Santa Maria da Feira, , Portugal
Investigational Site Number : 4100005
Cheonan-si, Chungcheongnam-do, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240003
Santiago de Compostela, A Coruña [La Coruña], Spain
Investigational Site Number : 7240008
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240004
Jerez de la Frontera, Cádiz, Spain
Investigational Site Number : 7240001
Majadahonda, Madrid, Spain
Investigational Site Number : 7240006
Seville, Sevilla, Spain
Investigational Site Number : 7240009
Sabadell, , Spain
Investigational Site Number : 7240005
Zaragoza, , Spain
Investigational Site Number : 7520002
Lund, , Sweden
Investigational Site Number : 7520001
Solna, , Sweden
Investigational Site Number : 7520004
Stockholm, , Sweden
Investigational Site Number : 7920003
Ankara, , Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 8260002
London, London, City of, United Kingdom
Investigational Site Number : 8260006
Oxford, Oxfordshire, United Kingdom
Investigational Site Number : 8260004
Bradford, , United Kingdom
Investigational Site Number : 8260001
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Facility Contacts
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Andrea Migliorelli
Role: primary
Carlotta Pipolo
Role: primary
Barbara Baraldo
Role: primary
Eugenio De Corso
Role: primary
Related Links
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EFC18418 Plain Language Results Summary
Other Identifiers
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2024-516814-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1306-4858
Identifier Type: REGISTRY
Identifier Source: secondary_id
EFC18418
Identifier Type: -
Identifier Source: org_study_id