At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with COPD for at least 1 year per GOLD definition
- ✓Moderate-to-severe COPD with post-bronchodilator FEV1/FVC <70% and FEV1% predicted <80% but ≥30%
- ✓CAT score ≥10 at screening
- ✓History of chronic productive cough for 3 months in the past year with other causes excluded
- ✕Concomitant severe diseases or conditions where ICS or LABA are contraindicated (active pulmonary tuberculosis, significant cardiovascular disease, insulin-dependent diabetes, hyperthyroidism, thyrotoxicosis, pheochromocytoma, hypokalemia)
- ✕Injectable or oral systemic glucocorticosteroids within the previous 1 month, or >4 courses of intravenous glucocorticosteroids within the previous 6 months
- ✕Bronchial thermoplasty procedure up to 3 years prior to Visit 1
- ✕Current diagnosis of asthma per GINA guidelines
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating SAR440340, Placebo, and 4 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 343 participants across 83 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
Pharmaceutical form: Solution for injection; Route of administration: SC
Pharmaceutical form: Solution for injection; Route of administration: SC
Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: Inhaled
Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled
Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: Inhaled
Pharmaceutical form: Aerosol or Dry Powder inhaler; Route of administration: inhaled