Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03546907 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 343
- Enrollment target
NCT03546907 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 343 participants.
The verdict
NCT03546907, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 343 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG SAR440340
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2020-02-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03546907
The ClinicalTrials.gov registry entry for NCT03546907 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03546907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03546907 about?
NCT03546907 is a clinical study titled "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)". 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 th...
What is the current status of trial NCT03546907?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 343 participants. The study started on 2018-07-16. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT03546907?
The interventions under investigation include: Placebo (DRUG), SAR440340 (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).
Who is sponsoring clinical trial NCT03546907?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.