Trials / Completed
CompletedNCT02414854
Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)
A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,902 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. * To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
Detailed description
The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm. |
| DRUG | Placebo | Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm. |
| DRUG | Inhaled corticosteroid (ICS) therapy | Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy) |
| DRUG | Albuterol/Salbutamol | Oral inhalation as needed |
| DRUG | Levalbuterol/Levosalbutamol | Oral inhalation as needed |
Timeline
- Start date
- 2015-04-27
- Primary completion
- 2017-07-29
- Completion
- 2017-11-23
- First posted
- 2015-04-13
- Last updated
- 2018-10-23
- Results posted
- 2018-10-23
Locations
389 sites across 22 countries: United States, Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02414854. Inclusion in this directory is not an endorsement.