Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
Public ClinicalTrials.gov record NCT03387852. 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, 12-week Proof-of-Concept (PoC) Study to Assess the Efficacy, Safety, and Tolerability of SAR440340 and the Coadministration of SAR440340 and Dupilumab in Patients With Moderate-to-Severe Asthma Who Are Not Well Controlled on Inhaled Corticosteroid (ICS) Plus Long-acting β2 Adrenergic Agonist (LABA) Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events. Secondary Objectives: To evaluate the effects of SAR440340/REGN3500 and coadministration of SAR440340 and dupilumab, compared with placebo, on forced expiratory volume in 1 second (FEV1). To evaluate the effects of coadministration of SAR440340 and dupilumab, compared with SAR440340 and compared with dupilumab, on FEV1. To assess safety and tolerability of SAR440340 alone and in coadministration with dupilumab.
Study identification
- NCT ID
- NCT03387852
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 296 participants
Conditions and interventions
Conditions
Interventions
- SAR440340 Drug
- Dupilumab Drug
- Fluticasone or Fluticasone/salmeterol combination Drug
- Placebo for SAR440340 Drug
- Placebo for dupilumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- Mar 12, 2018 (Actual)
- Primary completion
- Mar 21, 2019 (Actual)
- Completion
- Aug 7, 2019 (Actual)
- Last update posted
- Jun 14, 2022
2018 – 2019
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 8400026 | Birmingham | Alabama | 35209 | — |
| Investigational Site Number 8400004 | Long Beach | California | 90808 | — |
| Investigational Site Number 8400020 | Los Angeles | California | 90025 | — |
| Investigational Site Number 8400001 | Rolling Hills Estates | California | 90274 | — |
| Investigational Site Number 8400013 | San Jose | California | 95117 | — |
| Investigational Site Number 8400009 | Stockton | California | 95207 | — |
| Investigational Site Number 8400016 | Colorado Springs | Colorado | 80907 | — |
| Investigational Site Number 8400021 | Ann Arbor | Michigan | 48109 | — |
| Investigational Site Number 8400022 | Minneapolis | Minnesota | 55402 | — |
| Investigational Site Number 8400007 | Papillion | Nebraska | 27103 | — |
| Investigational Site Number 8400025 | Edmond | Oklahoma | 73034 | — |
| Investigational Site Number 8400011 | Medford | Oregon | 97504 | — |
| Investigational Site Number 8400024 | Portland | Oregon | 97209 | — |
| Investigational Site Number 8400010 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8400023 | Dallas | Texas | 75231 | — |
| Investigational Site Number 8400006 | Plano | Texas | 75093 | — |
| Investigational Site Number 8400008 | Murray | Utah | 84107 | — |
| Investigational Site Number 8400014 | Milwaukee | Wisconsin | 53219 | — |
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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03387852, 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 Jun 14, 2022 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03387852 live on ClinicalTrials.gov.