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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)

NCT03546907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2022-11-22

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-10-03
Completion
2020-02-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • Germany
  • Poland
  • Russia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546907 on ClinicalTrials.gov