ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-12-16
Study Completion:2027-02-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06691113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be 18 years of age or older.
  2. * 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).
  3. * 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).
  4. * Participants must have at least one of the following features:
  5. * Prior sinonasal surgery (as protocol defined) for chronic rhinosinusitis (CRS).
  6. * Treatment with systemic corticosteroid(s) (SCS) within the prior 2 years before Screening (Visit 1)
  7. * 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.
  8. * 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.
  9. * Participants must have a Sino-Nasal Outcome Test-22-Items (SNOT-22) score of ≥20 at Visit 1 and Visit 2.
  10. * Participants who have received a stable dose of mometasone furoate nasal spray (MFNS) for at least 3 weeks before Visit 2.
  11. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
  12. * Is not a women of childbearing potential (WOCBP). OR
  13. * 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).
  1. * Participants with conditions/concomitant diseases making them non-evaluable at Visit 1 or for the primary efficacy endpoint.
  2. * Participants with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil).
  3. * Radiological suspicion or confirmed invasive or expansive fungal rhinosinusitis.
  4. * 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.
  5. * Sinus surgery within 6 months before Screening (Visit 1)
  6. * Participants who received SCS 1 month prior to Screening (Visit 1) or during the screening period (between Visit 1 and Visit 2).
  7. * 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.
  8. * Participants with a history of severe systemic hypersensitivity reaction to mAb.
  9. * 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.

Contacts and Locations

Principal Investigator

Clinical Sciences & Operations
STUDY_DIRECTOR
Sanofi

Study Locations (Sites)

Allervie Clinical Research - Birmingham- Site Number : 8400006
Birmingham, Alabama, 35209
United States
Modena Allergy + Asthma- Site Number : 8400005
La Jolla, California, 92037
United States
United Medical Doctors - Murrieta- Site Number : 8400001
Murrieta, California, 92563
United States
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400008
Roseville, California, 95661
United States
Western States Clinical Research- Site Number : 8400009
Wheat Ridge, Colorado, 80033
United States
Advanced Research Associates (ARA) Professionals- Site Number : 8400002
Miami, Florida, 33176
United States
Treasure Valley Medical Research- Site Number : 8400022
Boise, Idaho, 83706
United States
ENT Associates of Texas - McKinne- Site Number : 8400013
McKinney, Texas, 75070
United States
Alamo ENT Associates- Site Number : 8400026
San Antonio, Texas, 78258
United States
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400007
Norfolk, Virginia, 23510
United States

Collaborators and Investigators

Sponsor: Sanofi

  • Clinical Sciences & Operations, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2027-02-09

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2027-02-09

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Rhinosinusitis Without Nasal Polyps