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)

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ClinicalTrials.gov Identifier: NCT03546907

Recruitment Status : Completed

First Posted : June 6, 2018

Last Update Posted : October 12, 2020

Sponsor:

Collaborator:

Regeneron Pharmaceuticals

Information provided by (Responsible Party):

Sanofi

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

Layout table for study information

Study Type :	Interventional (Clinical Trial)
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 :	July 16, 2018
Actual Primary Completion Date :	October 3, 2019
Actual Study Completion Date :	February 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

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