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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

StatusCompleted
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 7, 2026 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 312 to 314
    • Study sites: 138 to 117
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 13 to 14
  2. Trial status: Active, Not Recruiting to Completedv22
  3. Enrollment target: estimated 300 to confirmed 312
    • Primary completion date changed from estimate of Mar 24, 2026 to Sep 16, 2025
    • Study completion date: Aug 11, 2026 to Feb 2, 2026
    v21
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 140 to 138
    v20
  5. Study sites revised (140)v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 141 to 140v18
  2. Study sites: 137 to 141v17
  3. Study sites: 135 to 137v16
  4. Study sites: 123 to 135v15
  5. Study sites: 119 to 123v14
  6. Study sites: 112 to 119v13
  7. Study sites: 104 to 112v12
  8. Study sites: 91 to 104v11
  9. Study sites: 60 to 91v10
  10. Study sites: 46 to 60v9
  11. Study sites: 37 to 46v8
  12. Study sites: 22 to 37v7
  13. Study sites: 13 to 22v6
  14. Study sites: 9 to 13v5
  15. Study sites: 6 to 9v4
  16. Study sites: 1 to 6v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 23, 2024 to Feb 20, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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
Trial Details
NCT Number NCT06280391
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Bronchiectasis
Related terms Bronchiectasis
Enrollment 314 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov