2상모집 중단 (진행 중)
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
연구 개요
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.
- 스폰서
- 리드: 사노피 · 협력: 리제네론
- 적응증
- Chronic Rhinosinusitis Without Nasal Polyps
- 중재
- Itepekimab (SAR440340), Placebo, Mometasone furoate nasal spray (MFNS)
- 목표 등록
- 66명
- 시작일
- 2024-12-16
- 완료(예정)
- 2026-08-18
BioPulse가 제공하는 정보는 공개된 자료를 요약·정리한 것으로, 투자 조언이나 의료 조언이 아닙니다. 임상 데이터·규제 일정·공시 내용은 반드시 원문을 직접 확인하시기 바랍니다.