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Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

Study acronym: AERIFY-2
StatusCompleted
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 9, 2026 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 1239 to 1234
    • Study sites: 297 to 238
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 21 to 23
    • Study description expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv38
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Sep 8, 2025 to Aug 28, 2025
    v37
  4. Enrollment target: estimated 1210 to confirmed 1239
    • Study sites: 317 to 297
    • Primary completion date changed from estimate of May 30, 2025 to Apr 21, 2025
    • Study completion date: Oct 17, 2025 to Sep 8, 2025
    v36
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 317 of 317 sites
    • Study title shortened, about 1 word
    v35
Show 33 earlier versionsHide 33 earlier versions
  1. Study sites revised (317)v34
  2. Study sites: 315 to 317v33
  3. Study sites: 313 to 315v32
  4. Study sites revised (313)v31
  5. Study sites: 311 to 313v30
  6. Study sites: 315 to 311v29
  7. Study sites: 310 to 315
    • Secondary endpoints: details revised at 8 of 21 entries
    • Study description expanded, about 54 words
    v28
  8. Study sites: 266 to 310v27
  9. Study sites: 259 to 266v26
  10. Study sites: 254 to 259v25
  11. Study sites: 251 to 254v24
  12. Study sites: 250 to 251v23
  13. Study sites: 241 to 250v22
  14. Primary completion date: May 30, 2024 to May 30, 2025v21
  15. Primary completion date: Aug 26, 2024 to May 30, 2024
    • Study completion date: Jan 13, 2025 to Oct 17, 2025
    v20
  16. Study sites: 232 to 241v19
  17. Study sites: 224 to 232v18
  18. Enrollment target: 1170 to 1210v17 Show 4 more changesShow less
    • Study sites: 219 to 224
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (21)
    • Study description expanded, about 26 words
  19. Study sites: 212 to 219v16
  20. Study sites: 207 to 212
    • Primary completion date: Feb 2024 to Aug 26, 2024
    • Study completion date: Jul 2024 to Jan 13, 2025
    v15
  21. Site details revised at 1 of 207 sitesv14
  22. Study sites: 203 to 207v13
  23. Study sites: 190 to 203v12
  24. Study sites: 188 to 190v11
  25. Study sites: 182 to 188v10
  26. Study sites: 175 to 182v9
  27. Study sites: 172 to 175v8
  28. Study sites: 164 to 172v7
  29. Study sites: 21 to 164v6
  30. Study sites: 17 to 21v5
  31. Study sites: 2 to 17v4
  32. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 18, 2021 to Feb 12, 2021
    v3
  33. Re-verified, no change to tracked fieldsv2
  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
Primary Objective: Primary population (former smokers cohort): \- Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): * Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD * Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD * Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD * Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) * Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD * Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD * Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD * Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD * Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
Trial Details
NCT Number NCT04751487
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 1,234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov