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: Recruiting
Location: See all (56) 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
Alabama Allergy & Asthma Center - Birmingham - Brookwood Boulevard- Site Number : 8400006
RECRUITING
Birmingham
California
Modena Allergy + Asthma- Site Number : 8400005
RECRUITING
La Jolla
United Gastroenterologists - Murrieta- Site Number : 8400001
RECRUITING
Murrieta
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008
RECRUITING
Roseville
Colorado
Western States Clinical Research- Site Number : 8400009
RECRUITING
Wheat Ridge
Florida
Advanced Research Associates (ARA) Professionals- Site Number : 8400002
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Miami
Idaho
Treasure Valley Medical Research- Site Number : 8400022
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Boise
Texas
ENT Associates of Texas - McKinne- Site Number : 8400013
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Mckinney
Alamo ENT Associates- Site Number : 8400026
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San Antonio
Other Locations
Argentina
Investigational Site Number : 0320001
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Buenos Aires
Investigational Site Number : 0320004
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Corrientes
Investigational Site Number : 0320003
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San Miguel De Tucumán
Belgium
Investigational Site Number : 0560003
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Brussels
Investigational Site Number : 0560004
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Gesves Namur
Investigational Site Number : 0560002
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Ghent
Investigational Site Number : 0560001
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Leuven
Canada
Investigational Site Number : 1240005
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London
Investigational Site Number : 1240002
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Montreal
Investigational Site Number : 1240001
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Québec
Investigational Site Number : 1240003
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Québec
Investigational Site Number : 1240012
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Québec
Investigational Site Number : 1240009
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Trois-rivières
Chile
Investigational Site Number : 1520002
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Concepción
Investigational Site Number : 1520001
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Santiago
Investigational Site Number : 1520003
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Santiago
China
Investigational Site Number : 1560004
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Baotou
Investigational Site Number : 1560001
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Beijing
Investigational Site Number : 1560002
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Shanghai
Investigational Site Number : 1560003
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Zibo
France
Investigational Site Number : 2500012
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La Rochelle
Investigational Site Number : 2500004
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Marseille
Investigational Site Number : 2500005
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Montpellier
Investigational Site Number : 2500010
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Poitiers
Italy
Azienda Ospedaliero-Universitaria Pisana-Site Number : 3800003
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Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001
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Roma
Fondazione Policlinico Universitario Campus Bio-Medico-Site Number : 3800002
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Roma
Poland
Investigational Site Number : 6160004
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Bielsko-biala
Investigational Site Number : 6160006
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Krakow
Investigational Site Number : 6160008
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Lodz
Investigational Site Number : 6160002
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Poznan
Investigational Site Number : 6160001
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Warsaw
Portugal
Investigational Site Number : 6200001
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Guimarães
Investigational Site Number : 6200002
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Porto
Republic of Korea
Investigational Site Number : 4100005
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Cheonan-si
Investigational Site Number : 4100001
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Seoul
Investigational Site Number : 4100002
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Seoul
Investigational Site Number : 4100003
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Seoul
Investigational Site Number : 4100004
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Seoul
Romania
Investigational Site Number : 6420001
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Brasov
Investigational Site Number : 6420002
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Bucharest
Spain
Investigational Site Number : 7240003
RECRUITING
Barcelona
Investigational Site Number : 7240004
RECRUITING
Jerez De La Frontera
Investigational Site Number : 7240002
RECRUITING
L'hospitalet De Llobregat
Investigational Site Number : 7240006
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Madrid
Investigational Site Number : 7240005
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Pamplona
Investigational Site Number : 7240001
RECRUITING
Seville
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-12-16
Estimated 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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