NCT03546907

Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of SAR440340 (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety and Tolerability of SAR440340, in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To investigate effects of SAR440340 (anti-interleukin-33 \[IL-33\] monoclonal antibody \[mAb\]) compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over up to 52 weeks of treatment. * Moderate exacerbations were recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics. * Severe exacerbations were recorded by the Investigator and defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Secondary Objectives: To investigate effects of SAR440340 compared with placebo, on improving respiratory function, as assessed by pre-bronchodilator forced exploratory volume in 1 second (FEV1). To evaluate effects of SAR440340 compared with placebo, on post-bronchodilator FEV1. To evaluate effects of SAR440340 compared with placebo, on duration from baseline to first moderate or severe AECOPD event. To evaluate effects of SAR440340 compared with placebo, on safety and tolerability.

Detailed description

Study participation for each participant were up to a total of 46 weeks to 76 weeks including up to 10 days to 4 weeks of screening, 24-to-52 week treatment period on investigational medical product (IMP), and 20 weeks of post IMP treatment period.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	SAR440340	Pharmaceutical form: Solution for injection; Route of administration: SC
DRUG	Placebo	Pharmaceutical form: Solution for injection; Route of administration: SC
DRUG	Any Inhaled Corticosteroids as prescribed by treating physician as standard of care	Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled
DRUG	Any Long Acting Beta Agonist as prescribed by treating physician as standard of care	Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled
DRUG	Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care	Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled
DRUG	Any short-acting β agonist as prescribed by treating physician as standard of care	Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled

Timeline

• Start date: 2018-07-16
• Primary completion: 2019-10-03
• Completion: 2020-02-21
• First posted: 2018-06-06
• Last updated: 2022-11-22
• Results posted: 2022-11-22

Locations

83 sites across 10 countries: United States, Argentina, Australia, Canada, Chile, Germany, Poland, Russia, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study