Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01312961 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
NCT01312961: Completed Phase 2 study, sponsored by Sanofi.
NCT01312961 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01312961, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
Study Summary
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.
Primary Outcome
An asthma exacerbation was defined as the occurrence of any of the following: ≥30% reduction from baseline in morning PEF on 2 consecutive days; or ≥6 additional reliever puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; or deterioration of asthma, as determined by the investigator, requiring systemic steroid treatment, or an increase in inhaled corticosteroid (ICS) of ≥4 times the last dose received prior to discontinuation from the study, or h
Interventions
- DRUG Dupilumab
- DRUG Albuterol
- DRUG Placebo (for Dupilumab)
- DRUG Fluticasone/Salmeterol combination therapy
- DRUG Fluticasone monotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT01312961 record still lists
NCT01312961 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 5 interventions - of which Dupilumab is the first listed.
NCT01312961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01312961 about?
NCT01312961 is a clinical study titled "Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma". 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 Ob...
What is the current status of trial NCT01312961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2011-03. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01312961?
The interventions under investigation include: Dupilumab (DRUG), Albuterol (DRUG), Placebo (for Dupilumab) (DRUG), Fluticasone/Salmeterol combination therapy (DRUG), Fluticasone monotherapy (DRUG).
Who is sponsoring clinical trial NCT01312961?
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 NCT01312961's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03403686 · 104 participants
Liver X Receptor (LXR) as a Novel Therapeutic Target in Diabetic Retinopathy (DR)
- NCT04228367 · 104 participants · NA
JuggerStitch Post Market Clinical Follow-up Study
- NCT04268849 · 104 participants · Phase 3
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
- NCT04390724 · 104 participants
Optimizing Y90 Therapy for Radiation Lobectomy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia