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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of Itepekimab, in Participants With Non-cystic Fibrosis Bronchiectasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is 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) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Itepekimab (SAR440340)	Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Timeline

• Start date: 2024-02-20
• Primary completion: 2025-09-16
• Completion: 2026-02-02
• First posted: 2024-02-28
• Last updated: 2026-02-12

Locations

138 sites across 20 countries: United States, Argentina, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Poland, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study