drugset / Trial / NCT06280391

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

NCT06280391 ↗

Phase 2 Completed 314 enrolled Sanofi Regeneron Pharmaceuticals · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study was to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) was up to 47-77 weeks * The treatment duration was up to 24-52 weeks * The follow-up duration was 20 weeks * Site/phone visits were at a monthly interval

Timeline

Start
2024-02-20
Primary completion
2025-09-16
Completion
2026-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Itepekimab Monoclonal antibody 300 mg Subcutaneous

Indications