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A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

Study acronym: AERIFY-4
StatusCompleted
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 1, 2026 to Sep 10, 2026
    • Enrollment target: estimated 700 to confirmed 669
    • Secondary endpoints: details revised at 2 of 11 entries
    • Site details revised at 2 of 223 sites
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv22
  3. Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints revised (11)
    • Site details revised at 223 of 223 sites
    v21
  4. Study sites: 218 to 223v20
  5. Study sites: 198 to 218v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 182 to 198v18
  2. Study sites: 179 to 182v17
  3. Study sites: 172 to 179v16
  4. Study sites: 167 to 172v15
  5. Study sites: 155 to 167v14
  6. Study sites: 113 to 155v13
  7. Study sites: 105 to 113v12
  8. Study sites: 96 to 105v11
  9. Study sites: 79 to 96v10
  10. Study sites: 54 to 79v9
  11. Study sites: 45 to 54v8
  12. Study sites: 37 to 45v7
  13. Study sites: 17 to 37v6
  14. Study sites: 9 to 17v5
  15. Study sites: 6 to 9v4
  16. Study sites: 2 to 6
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 2 of 11 entries
    v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 16, 2024 to Jan 11, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
COPD
1,119 trials monitored
See 34 trials at risk
This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: * The study duration will be up to 72 weeks * The treatment duration will be up to 52 weeks * A follow-up period of 20 weeks will be conducted * The number of on-site visits will be 7 and the number of phone contacts will be 5
Trial Details
NCT Number NCT06208306
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 669 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov