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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-1
StatusCompleted
PhasePhase 3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 15, 2026 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 248 to 232
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: 15 to 18
    • Study description expanded, about 3 words
  2. Re-verified, no change to tracked fieldsv40
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Sep 1, 2025 to Aug 27, 2025
    v39
  4. Enrollment target: estimated 960 to confirmed 1127
    • Primary completion date changed from estimate of Jun 27, 2025 to Apr 11, 2025
    • Study completion date: Nov 28, 2025 to Sep 1, 2025
    v38
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 248 of 248 sites
    v37
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 246 to 248v36
  2. Study sites: 242 to 246v35
  3. Study sites: 238 to 242v34
  4. Study sites: 235 to 238v33
  5. Study sites: 233 to 235v32
  6. Study sites: 229 to 233v31
  7. Study sites: 224 to 229v30
  8. Study sites: 221 to 224v29
  9. Study sites: 219 to 221v28
  10. Study sites: 217 to 219
    • Secondary endpoints: details revised at 4 of 15 entries
    • Study description expanded, about 54 words
    v27
  11. Study sites: 199 to 217v26
  12. Re-verified, no change to tracked fieldsv25
  13. Study sites: 194 to 199v24
  14. Study sites: 196 to 194v23
  15. Study sites: 190 to 196v22
  16. Study sites: 187 to 190v21
  17. Study sites: 179 to 187v20
  18. Primary completion date: Jun 13, 2024 to Jun 27, 2025
    • Study completion date: Oct 31, 2024 to Nov 28, 2025
    v19
  19. Study sites: 168 to 179v18
  20. Study sites revised (168)v17
  21. Enrollment target: 930 to 960v16 Show 4 more changesShow less
    • Study sites: 167 to 168
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints revised (15)
    • Study description expanded, about 12 words
  22. Study sites: 162 to 167v15
  23. Study sites: 159 to 162
    • Primary completion date: Dec 2023 to Jun 13, 2024
    • Study completion date: May 2024 to Oct 31, 2024
    v14
  24. Study sites: 158 to 159v13
  25. Study sites: 154 to 158v12
  26. Re-verified, no change to tracked fieldsv11
  27. Study sites: 151 to 154v10
  28. Study sites: 147 to 151v9
  29. Study sites: 142 to 147v8
  30. Study sites: 128 to 142v7
  31. Study sites: 51 to 128v6
  32. Study sites: 30 to 51v5
  33. Study sites: 3 to 30v4
  34. Study sites: 2 to 3v3
  35. Study sites: 1 to 2v2
  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: 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: * 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
Trial Details
NCT Number NCT04701983
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 1,127 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov