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)

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT03546907

Collaborator

Regeneron Pharmaceuticals (Industry)

343

Enrollment

Locations

Arms

19.2

Actual Duration (Months)

4.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 are recorded by the Investigator and defined as AECOPD that require either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
Severe exacerbations are 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Itepekimab (SAR440340) Drug: Placebo Drug: Any Inhaled Corticosteroids as prescribed by treating physician as standard of care Drug: Any Long Acting Beta Agonist as prescribed by treating physician as standard of care Drug: Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care Drug: Any short-acting β agonist as prescribed by treating physician as standard of care	Phase 2

Detailed Description

Study participation for each patient will be 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

343 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Jul 16, 2018

Actual Primary Completion Date :

Oct 3, 2019

Actual Study Completion Date :

Feb 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAR440340 Administration of SAR440340 monotherapy injection	Drug: Itepekimab (SAR440340) Pharmaceutical form: Solution for injection Route of administration: Subcutaneous 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
Placebo Comparator: Placebo Administration of matching placebo for injection of SAR440340	Drug: Placebo Pharmaceutical form: Solution for injection Route of administration: Subcutaneous 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

Arm

Intervention/Treatment

Experimental: SAR440340

Administration of SAR440340 monotherapy injection

Drug: Itepekimab (SAR440340)

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

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

Placebo Comparator: Placebo

Administration of matching placebo for injection of SAR440340

Drug: Placebo