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: 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

Key Dates

Start date

Dec 16, 2020

Status verified

Apr 2026

Primary completion

Apr 11, 2025

Completion

Aug 27, 2025

Study Design

Enrollment

1,127 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Itepekimab Q2W
  Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
• Experimental: Itepekimab Q4W
  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
  SC administration of matching placebo Q2W for up to 52 weeks

Primary Outcome Measure

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

Locations (86)

Related coverage on Hipa.ai

• Itepekimab Phase 3 Trial for COPD Reaches Primary Completion
  Itepekimab (SAR440340) · Apr 11, 2025 · ClinicalTrials.gov

Find similar trials in Birmingham, AL

Related Studies

• Emphysema Research Registry and Biosample Repository
  Recruiting · University of Pittsburgh · Pittsburgh, Pennsylvania
• Boston Early-Onset Chronic Obstructive Pulmonary Disease (COPD) Study
  Recruiting · Brigham and Women's Hospital · Boston, Massachusetts
• CareCOPD - COPD Home Monitoring Study
  Recruiting · Cognita Labs LLC · Ventura, California
• Goals of Care Conversations Study
  Enrolling By Invitation · VA Office of Research and Development · Palo Alto, California