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

Status: Active_not_recruiting
Location: See all (57) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alabama
Allervie Clinical Research - Birmingham- Site Number : 8400006
Birmingham
California
Modena Allergy + Asthma- Site Number : 8400005
La Jolla
United Medical Doctors - Murrieta- Site Number : 8400001
Murrieta
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008
Roseville
Colorado
Western States Clinical Research- Site Number : 8400009
Wheat Ridge
Florida
Advanced Research Associates (ARA) Professionals- Site Number : 8400002
Miami
Idaho
Treasure Valley Medical Research- Site Number : 8400022
Boise
Texas
ENT Associates of Texas - McKinne- Site Number : 8400013
Mckinney
Alamo ENT Associates- Site Number : 8400026
San Antonio
Virginia
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400007
Norfolk
Other Locations
Argentina
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320004
Corrientes
Investigational Site Number : 0320003
San Miguel De Tucumán
Belgium
Investigational Site Number : 0560003
Brussels
Investigational Site Number : 0560004
Gesves
Investigational Site Number : 0560002
Ghent
Investigational Site Number : 0560001
Leuven
Canada
Investigational Site Number : 1240005
London
Investigational Site Number : 1240002
Montreal
Investigational Site Number : 1240001
Québec
Investigational Site Number : 1240003
Québec
Investigational Site Number : 1240012
Québec
Investigational Site Number : 1240009
Trois-rivières
Chile
Investigational Site Number : 1520002
Concepción
Investigational Site Number : 1520001
Santiago
Investigational Site Number : 1520003
Santiago
China
Investigational Site Number : 1560004
Baotou
Investigational Site Number : 1560001
Beijing
Investigational Site Number : 1560002
Shanghai
Investigational Site Number : 1560003
Zibo
France
Investigational Site Number : 2500012
La Rochelle
Investigational Site Number : 2500004
Marseille
Investigational Site Number : 2500005
Montpellier
Investigational Site Number : 2500010
Poitiers
Italy
Azienda Ospedaliero-Universitaria Pisana-Site Number : 3800003
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
Rome
Fondazione Policlinico Universitario Campus Bio-Medico-Site Number : 3800002
Rome
Poland
Investigational Site Number : 6160004
Bielsko-biala
Investigational Site Number : 6160006
Krakow
Investigational Site Number : 6160008
Lodz
Investigational Site Number : 6160002
Poznan
Investigational Site Number : 6160001
Warsaw
Portugal
Investigational Site Number : 6200001
Guimarães
Investigational Site Number : 6200002
Porto
Republic of Korea
Investigational Site Number : 4100005
Cheonan-si
Investigational Site Number : 4100001
Seoul
Investigational Site Number : 4100002
Seoul
Investigational Site Number : 4100003
Seoul
Investigational Site Number : 4100004
Seoul
Romania
Investigational Site Number : 6420001
Brasov
Investigational Site Number : 6420002
Bucharest
Spain
Investigational Site Number : 7240003
Barcelona
Investigational Site Number : 7240004
Jerez De La Frontera
Investigational Site Number : 7240002
L'hospitalet De Llobregat
Investigational Site Number : 7240006
Madrid
Investigational Site Number : 7240005
Pamplona
Investigational Site Number : 7240001
Seville
Time Frame
Start Date: 2024-12-16
Completion Date: 2027-02-09
Participants
Target number of participants: 60
Treatments
Experimental: Itepekimab high dose
Subcutaneous (SC) administration of Itepekimab high dose for 24 weeks
Experimental: Itepekimab low dose
SC administration of Itepekimab low dose for 24 weeks
Placebo_comparator: Placebo
SC administration of matching placebo for 24 weeks
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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