Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06280391 · ClinicalTrials.gov registry record · Phase 2

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 Phase 2 study, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
312
Enrollment target

NCT06280391: Completed Phase 2 study, sponsored by Sanofi.

NCT06280391 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 312 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06280391, a Phase 2 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
312 participants
Enrollment target

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.

Primary Outcome

Annualized rate of moderate or severe PEs over the placebo-controlled treatment period

Interventions

  • DRUG Placebo
  • DRUG Itepekimab (SAR440340)

Trial Details

FieldValue
Enrollment Target 312 participants
Start Date 2024-02-20
Est. Completion 2026-02-02
Phase Phase 2
Sanofi

713 total trials

What the finished NCT06280391 record still lists

NCT06280391 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (135% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT06280391 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06280391 about?

NCT06280391 is a clinical study titled "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". 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 w...

What is the current status of trial NCT06280391?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 312 participants. The study started on 2024-02-20. Estimated completion is 2026-02-02.

What interventions are being tested in trial NCT06280391?

The interventions under investigation include: Placebo (DRUG), Itepekimab (SAR440340) (DRUG).

Who is sponsoring clinical trial NCT06280391?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06280391's enrollment target sits among peer trials

312 161st of 2000 higher than 1,839 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04984551 · 312 participants · Phase 2

    Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia

  • NCT04999904 · 312 participants · NA

    A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability

  • NCT05220332 · 312 participants · NA

    Church-based Intervention to Improve Blood Pressure in African Americans

  • NCT05434234 · 312 participants · Phase 1

    A Study of YL201 in Patients With Advanced Solid Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT06280391, the US trial registry maintained by the National Library of Medicine. NCT06280391 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.