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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: Completed Phase 2 study, sponsored by Sanofi.
NCT03546907 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 343 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (158% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Moderate exacerbations events 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 events were defined as AECOPD requiring hospitalization, emergency medical care visit or resulting in death. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
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 |
What the finished NCT03546907 record still lists
NCT03546907 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (158% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03546907 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03546907's enrollment target sits among peer trials
343 136th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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