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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-02-12

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-09-16
Completion
2026-02-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06280391 on ClinicalTrials.gov