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)
Public ClinicalTrials.gov record NCT03546907. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03546907
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 343 participants
Conditions and interventions
Conditions
Interventions
- 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 Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 15, 2018
- Primary completion
- Oct 2, 2019
- Completion
- Feb 20, 2020
- Last update posted
- Nov 21, 2022
2018 – 2020
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400002 | Los Angeles | California | 90025 | — |
| Investigational Site Number 8400003 | Riverside | California | 92506 | — |
| Investigational Site Number 8400006 | Rolling Hills Estates | California | 90274 | — |
| Investigational Site Number 8400015 | Westminster | California | 92683 | — |
| Investigational Site Number 8400013 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 8400012 | Columbia | Maryland | 21044 | — |
| Investigational Site Number 8400016 | North Dartmouth | Massachusetts | 02747 | — |
| Investigational Site Number 8400020 | South Dartmouth | Massachusetts | 02747 | — |
| Investigational Site Number 8400011 | Minneapolis | Minnesota | 55407 | — |
| Investigational Site Number 8400005 | Jamaica | New York | 11418-2619 | — |
| Investigational Site Number 8400019 | Chapel Hill | North Carolina | 27517 | — |
| Investigational Site Number 8400004 | Raleigh | North Carolina | 27607 | — |
| Investigational Site Number 8400001 | Medford | Oregon | 97504 | — |
| Investigational Site Number 8400009 | Philadelphia | Pennsylvania | 19140 | — |
| Investigational Site Number 8400007 | Plano | Texas | 75093 | — |
| Investigational Site Number 8400008 | Greenfield | Wisconsin | 53228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03546907, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 21, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03546907 live on ClinicalTrials.gov.