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
NCT ID: NCT06691113
Last Updated: 2025-11-12
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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ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-12-16
2027-02-09
Brief Summary
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Study details include:
* The study duration (4-week screening, 24--week intervention, 20--week safety followup) will be 48 weeks.
* The intervention duration will be 24 weeks.
* The number of visits will be 7 site visits and 8 phone/remote 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 24 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 24 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 24 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 must have ongoing symptoms of nasal congestion/obstruction at least 12 consecutive weeks before Visit 1 and a Nasal Congestion Score (NCS) ≥2 at Visit 1 (day score) and Visit 2 (weekly average score).
* Participants must have sinus Total Symptom Score (sTSS) (NC, rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (day score) and Visit 2 (weekly average score).
* Participants must have at least one of the following features:
* Prior sinonasal surgery (as protocol defined) for chronic rhinosinusitis (CRS).
* Treatment with systemic corticosteroid(s) (SCS) within the prior 2 years before Screening (Visit 1)
* Worsening symptoms of CRS in the past 2 years which would have required treatment with SCS, however participant is intolerant or has a contraindication to SCS.
* Participants must have bilateral inflammation of paranasal sinuses with bilateral ethmoid and maxillary opacification on screening CT scan. Participants must have ≥25% opacification of the ethmoid sinuses and ≥25% opacification of at least 1 maxillary sinus by central reading of CT scan.
* Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT-22) score of ≥20 at Visit 1 and Visit 2.
* Participants who have received a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before Visit 2.
* 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 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).
* Radiological suspicion or confirmed invasive or expansive fungal rhinosinusitis.
* Have any clinically significant diseases or disorders (eg, cardiovascular, pulmonary, gastrointestinal, liver, kidney, neurological, musculoskeletal, endocrine, metabolic, psychiatric, physical impairment) that, in the opinion of the Investigator, may put the subject at risk by participating in the study, or interfere with the subject's intervention, assessment, or influence the results of the study, or have compliance issues with the study.
* Sinus surgery within 6 months before Screening (Visit 1)
* Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
* Participants treated with other intranasal corticosteroid(s) (INCS) (only study provided AxMP \[MFNS\] is permitted), intranasal emitting devices/stents, nasal spray using exhalation delivery system such as Xhance™ during the screening period.
* Participants with a history of severe systemic hypersensitivity reaction to mAb.
* Known allergy to itepekimab or to its excipients. Any drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
The above information is not intended to contain all considerations relevant to a patient'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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Allervie Clinical Research - Birmingham- Site Number : 8400006
Birmingham, Alabama, United States
Modena Allergy + Asthma- Site Number : 8400005
La Jolla, California, United States
United Medical Doctors - Murrieta- Site Number : 8400001
Murrieta, California, United States
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008
Roseville, California, United States
Western States Clinical Research- Site Number : 8400009
Wheat Ridge, Colorado, United States
Advanced Research Associates (ARA) Professionals- Site Number : 8400002
Miami, Florida, United States
Treasure Valley Medical Research- Site Number : 8400022
Boise, Idaho, United States
ENT Associates of Texas - McKinne- Site Number : 8400013
McKinney, Texas, United States
Alamo ENT Associates- Site Number : 8400026
San Antonio, Texas, United States
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400007
Norfolk, Virginia, United States
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Corrientes, , Argentina
Investigational Site Number : 0560003
Brussels, , Belgium
Investigational Site Number : 0560004
Gesves, , Belgium
Investigational Site Number : 0560002
Ghent, , Belgium
Investigational Site Number : 0560001
Leuven, , Belgium
Investigational Site Number : 1240005
London, Ontario, Canada
Investigational Site Number : 1240002
Montreal, Quebec, Canada
Investigational Site Number : 1240001
Québec, Quebec, Canada
Investigational Site Number : 1240003
Québec, Quebec, Canada
Investigational Site Number : 1240012
Québec, Quebec, Canada
Investigational Site Number : 1240009
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Concepción, Región del Biobío, Chile
Investigational Site Number : 1560004
Baotou, , China
Investigational Site Number : 1560001
Beijing, , China
Investigational Site Number : 1560002
Shanghai, , China
Investigational Site Number : 1560003
Zibo, , China
Investigational Site Number : 2500012
La Rochelle, , France
Investigational Site Number : 2500004
Marseille, , France
Investigational Site Number : 2500005
Montpellier, , France
Investigational Site Number : 2500010
Poitiers, , France
Fondazione Policlinico Universitario Campus Bio-Medico-Site Number : 3800002
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
Rome, Roma, Italy
Azienda Ospedaliero-Universitaria Pisana-Site Number : 3800003
Pisa, , Italy
Investigational Site Number : 6160002
Poznan, Greater Poland Voivodeship, Poland
Investigational Site Number : 6160006
Krakow, Lesser Poland Voivodeship, Poland
Investigational Site Number : 6160008
Lodz, Lódzkie, Poland
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, Poland
Investigational Site Number : 6160004
Bielsko-Biala, Silesian Voivodeship, Poland
Investigational Site Number : 6200001
Guimarães, , Portugal
Investigational Site Number : 6200002
Porto, , Portugal
Investigational Site Number : 6420001
Brasov, , Romania
Investigational Site Number : 6420002
Bucharest, , Romania
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
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain
Investigational Site Number : 7240004
Jerez de la Frontera, Cádiz, Spain
Investigational Site Number : 7240005
Pamplona, Navarre, Spain
Investigational Site Number : 7240001
Seville, Sevilla, Spain
Investigational Site Number : 7240006
Madrid, , Spain
Countries
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Related Links
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ACT18421 Plain Language Results Summary
Other Identifiers
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2024-515576-12
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1306-6643
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACT18421
Identifier Type: -
Identifier Source: org_study_id