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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT06280391

Public ClinicalTrials.gov record NCT06280391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 10:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT06280391
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
314 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 20, 2024 (Actual)
Primary completion
Sep 16, 2025 (Actual)
Completion
Feb 2, 2026 (Actual)
Last update posted
Oct 7, 2026

2024 – 2026

United States locations

U.S. sites
23
U.S. states
14
U.S. cities
23
Facility City State ZIP Site status
Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012 Phoenix Arizona 85006 —
Southern California Institute for Respiratory Diseases- Site Number : 8400002 Los Angeles California 90048 —
Allianz Research Institute- Site Number : 8400013 Westminster California 92683 —
Allianz Research Institute CO- Site Number : 8400038 Aurora Colorado 80014 —
University of Connecticut Health Center- Site Number : 8400020 Farmington Connecticut 06032 —
Yale New Haven Hospital- Site Number : 8400065 New Haven Connecticut 06510 —
Advanced Pulmonary Research Institute- Site Number : 8400007 Loxahatchee Groves Florida 33470 —
High Quality Research- Site Number : 8400047 Miami Florida 33184 —
Avanza Medical Research Center- Site Number : 8400018 Pensacola Florida 32503 —
Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400010 Plantation Florida 33324 —
Northwestern Memorial Hospital- Site Number : 8400043 Chicago Illinois 60611 —
University of Kansas Medical Center- Site Number : 8400045 Kansas City Kansas 66160 —
University of Michigan Health System - Ann Arbor- Site Number : 8400055 Ann Arbor Michigan 48109 —
Pulmonary and Medicine Associates- Site Number : 8400057 Warren Michigan 48088 —
Washington University- Site Number : 8400046 St Louis Missouri 63110 —
NYU Langone Medical Center- Site Number : 8400032 New York New York 10016 —
Southeastern Research Center- Site Number : 8400008 Winston-Salem North Carolina 27103 —
Clinical Research Associates of Central PA - Dubois- Site Number : 8400005 DuBois Pennsylvania 15801 —
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400039 Philadelphia Pennsylvania 19104 —
Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8400027 Charleston South Carolina 29425 —
Metroplex Pulmonary and Sleep Center- Site Number : 8400014 McKinney Texas 75069 —
Pioneer Research Solutions, Inc.- Site Number : 8400048 Sugar Land Texas 77479 —
The University of Texas Health Center at Tyler- Site Number : 8400053 Tyler Texas 75708 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 94 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06280391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 7, 2026 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06280391 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →