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ACTIVE NOT RECRUITING

NCT06691113

PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

ACT18421 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 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 in male and female participants with chronic rhinosinusitis without nasal polyps (CRSsNP) aged 18 years of age and older. 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.

Official title: A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab in Participants With Inadequately Controlled Chronic Rhinosinusitis Without Nasal Polyps

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-16

Completion Date

2027-02-09

Last Updated

2025-11-12

Healthy Volunteers

Conditions

Chronic Rhinosinusitis Without Nasal Polyps

Interventions

DRUG

Itepekimab (SAR440340)

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution for injection in prefilled syringe. Route of administration: Subcutaneous

DRUG

Mometasone furoate nasal spray (MFNS)

Pharmaceutical form: Solution for administration via spray pump. Route of administration: Intranasal spray

Inclusion Criteria: * Participant must be 18 years of age or older. * 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 are excluded from the study if any of the following criteria apply: * 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.

Locations (57)

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)