Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Public ClinicalTrials.gov record NCT01312961. 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
Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of SAR231893/REGN668 Administered Subcutaneously Once Weekly for 12 Weeks in Patients With Persistent Moderate to Severe Eosinophilic Asthma Who Are Partially Controlled/Uncontrolled by Inhaled Corticosteroid Plus Long-acting beta2 Agonist Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants with persistent moderate to severe eosinophilic asthma. Secondary Objectives: * To assess the safety and tolerability of Dupilumab administered SC qw for 12 weeks in participants with persistent moderate to severe eosinophilic asthma. * To assess Dupilumab serum concentrations following qw SC dosing for 12 weeks in participants with persistent moderate to severe eosinophilic asthma.
Study identification
- NCT ID
- NCT01312961
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 104 participants
Conditions and interventions
Conditions
Interventions
- Dupilumab Drug
- Placebo (for Dupilumab) Drug
- Fluticasone/Salmeterol combination therapy Drug
- Fluticasone monotherapy Drug
- Albuterol Drug
- Levalbuterol Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 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 2011 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Oct 2012 (Actual)
- Last update posted
- Jun 8, 2017
2011 – 2012
United States locations
- U.S. sites
- 50
- U.S. states
- 26
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840047 | Anaheim | California | 92804 | — |
| Investigational Site Number 840046 | Long Beach | California | 90806 | — |
| Investigational Site Number 840032 | Los Angeles | California | 90025 | — |
| Investigational Site Number 840036 | Los Angeles | California | 90048 | — |
| Investigational Site Number 840005 | Mission Viejo | California | 92691 | — |
| Investigational Site Number 840007 | Orange | California | 92868 | — |
| Investigational Site Number 840048 | Riverside | California | 92506 | — |
| Investigational Site Number 840035 | Rolling Hills Estates | California | 90274 | — |
| Investigational Site Number 840041 | San Francisco | California | 94143 | — |
| Investigational Site Number 840042 | San Francisco | California | 94143 | — |
| Investigational Site Number 840039 | San Jose | California | 95117 | — |
| Investigational Site Number 840024 | Santa Rosa | California | 95405 | — |
| Investigational Site Number 840002 | Stockton | California | 95207 | — |
| Investigational Site Number 840031 | Colorado Springs | Colorado | 80907 | — |
| Investigational Site Number 840011 | Denver | Colorado | 80206 | — |
| Investigational Site Number 840017 | Denver | Colorado | 80230 | — |
| Investigational Site Number 840026 | New Haven | Connecticut | 06510 | — |
| Investigational Site Number 840044 | Tallahassee | Florida | 32308 | — |
| Investigational Site Number 840029 | Tampa | Florida | 33612 | — |
| Investigational Site Number 840028 | Indianapolis | Indiana | 46208 | — |
| Investigational Site Number 840038 | Iowa City | Iowa | 52240 | — |
| Investigational Site Number 840021 | Overland Park | Kansas | 66210 | — |
| Investigational Site Number 840053 | Owensboro | Kentucky | 42303 | — |
| Investigational Site Number 840014 | Baltimore | Maryland | 21287 | — |
| Investigational Site Number 840015 | North Dartmouth | Massachusetts | 02747 | — |
| Investigational Site Number 840003 | Minneapolis | Minnesota | 55402 | — |
| Investigational Site Number 840010 | Minneapolis | Minnesota | 55402 | — |
| Investigational Site Number 840006 | St Louis | Missouri | 63110 | — |
| Investigational Site Number 840013 | St Louis | Missouri | 63141 | — |
| Investigational Site Number 840022 | Bozeman | Montana | 59718 | — |
| Investigational Site Number 840025 | Omaha | Nebraska | 68131 | — |
| Investigational Site Number 840008 | Papillion | Nebraska | 27103 | — |
| Investigational Site Number 840018 | Princeton | New Jersey | 08540 | — |
| Investigational Site Number 840004 | Winston-Salem | North Carolina | 27157-1071 | — |
| Investigational Site Number 840023 | Sylvania | Ohio | 43560 | — |
| Investigational Site Number 840045 | Oklahoma City | Oklahoma | 73120 | — |
| Investigational Site Number 840001 | Lake Oswego | Oregon | 97035 | — |
| Investigational Site Number 840012 | Medford | Oregon | 97504 | — |
| Investigational Site Number 840016 | Portland | Oregon | 97209 | — |
| Investigational Site Number 840040 | Hershey | Pennsylvania | 17033 | — |
| Investigational Site Number 840037 | Pittsburgh | Pennsylvania | 15213 | — |
| Investigational Site Number 840009 | Upland | Pennsylvania | 19013 | — |
| Investigational Site Number 840027 | Charleston | South Carolina | 29407 | — |
| Investigational Site Number 840030 | El Paso | Texas | 79902 | — |
| Investigational Site Number 840050 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840052 | South Burlington | Vermont | 05403 | — |
| Investigational Site Number 840049 | Richmond | Virginia | 23229 | — |
| Investigational Site Number 840020 | Seattle | Washington | 98105 | — |
| Investigational Site Number 840019 | Tacoma | Washington | 98415-0299 | — |
| Investigational Site Number 840034 | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01312961, 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 8, 2017 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01312961 live on ClinicalTrials.gov.