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

Conditions

• Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Itepekimab SAR440340 — DRUG
  Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
• Placebo — DRUG
  Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Study Details

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

Key Dates

Start date

Feb 12, 2021

Status verified

Apr 2026

Primary completion

Apr 21, 2025

Completion

Aug 28, 2025

Study Design

Enrollment

1,239 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Itepekimab Q2W in former smokers
  Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
• Experimental: Itepekimab Q4W in former smokers
  SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
• Placebo Comparator: Placebo in former smokers
  SC administration of matching placebo Q2W for up to 52 weeks
• Experimental: Itepekimab Q2W in current smokers
  SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks
• Placebo Comparator: Placebo in current smokers
  SC administration of matching placebo Q2W for 52 weeks

Primary Outcome Measure

Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers [ Time Frame: Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants) ]

Locations (71)

Related coverage on Hipa.ai

• Itepekimab Phase 3 COPD Trial for 1239 Patients Reaches Primary Completion
  Itepekimab (SAR440340) · Apr 21, 2025 · ClinicalTrials.gov

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