NCT04701983

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

Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,127 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study duration per participant: * Screening period is 3-5 weeks * Placebo-controlled treatment period is 52 weeks for first approximately 960 randomized participants, and 24 to 52 weeks for potential additional randomized participants * Post-investigational medicinal product (IMP) treatment follow-up period is 20 weeks for participants not transitioning to the extension study LTS18133 Note: A long-term, double-blinded extension study (LTS18133) will be implemented to allow participants in this study to continue receiving active IMP for an additional period. Only participants completing their End-of-Treatment (EOT) visit per this study protocol will be offered to participate in the LTS18133 study.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Itepekimab SAR440340	Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
DRUG	Placebo	Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Timeline

• Start date: 2020-12-16
• Primary completion: 2025-04-11
• Completion: 2025-08-27
• First posted: 2021-01-08
• Last updated: 2026-04-15

Locations

248 sites across 21 countries: United States, Argentina, Bulgaria, Chile, China, Czechia, Georgia, Greece, Hungary, India, Israel, Italy, Mauritius, Mexico, Poland, Romania, Russia, Slovakia, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study