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NCT07484230
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Sponsor: Sanofi
Summary
This is a randomized, multicenter, double-blind, Phase 3 study with 2 parallel groups. The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different dosing regimens of itepekimab monotherapy in Japanese participants aged 18 years or older with chronic rhinosinusitis with nasal polyp(s) (CRSwNP) who are not adequately controlled despite previous surgery and/or treatment with systemic corticosteroid(s) (SCS).
The total study duration par participant is approximately 76 week, including:
* A screening period for up to 4 weeks.
* A randomized study intervention period for up to 52 weeks
* A post-intervention safety follow-up for up to 20 weeks
* The number of visits will be 9 site visits and 20 phone/home visits
Eligibility Criteria
Inclusion Criteria:
* Participants must be 18 years of age or older.
* Participants with a history of CRSwNP for at least 1 year.
* Participants must have at least one of the following features:
* Prior sinonasal surgery for NP.
* Worsening symptoms of CRS requiring treatment with SCS within the prior 1 year.
* An endoscopic bilateral NPS of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity).
* Ongoing symptoms (for at least 12 weeks before Visit 1) of:
* Nasal congestion/blockade/obstruction with moderate or severe symptom (score of 2 or 3), AND
* At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).
* Not currently on and have not been receiving INCS for at least one month.
* 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 \
Source: ClinicalTrials.gov (NCT07484230). StuddyBuddy aggregates publicly available trial information.