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

Not Recruiting

Open to: ALL

Age: 18.0 - 85.0

Medical Conditions

Bronchiectasis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2024 Mar 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Intervention Arm Group : Itepekimab Q2W;Itepekimab Q4W;

Intervention Type : DRUG
Intervention Description : Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Intervention Arm Group : Itepekimab Q4W;Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Investigational Site Number : 8260001
    Newcastle Upon Tyne
    NE7 7DN
  • Investigational Site Number : 8260008
    Norwich
    Norfolk
    NR4 7UY
  • Investigational Site Number : 8260005
    Reading
    RG1 5AN
  • Investigational Site Number : 8260004
    Lancaster
    LA1 4RP
  • Investigational Site Number : 8260003
    North Shields
    North Tyneside
    NE29 8NH
  • Investigational Site Number : 8260009
    Cambridge
    Cambridgeshire
    CB23 3RE


The study is sponsored by Sanofi and is in collaboration with Regeneron Pharmaceuticals.




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Read full details for Trial ID: NCT06280391
Last updated 27 April 2025

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