Trials / Completed
CompletedNCT02501629
An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 177 (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Reslizumab | Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes. |
| DRUG | Placebo | Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes. |
| DRUG | Non-Oral Corticosteroid (non-OCS) Asthma Medication | Participants continue using their non-OCS background asthma medications without change during the study's treatment period. |
| DRUG | Oral Corticosteroid (OCS) | After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement. |
Timeline
- Start date
- 2015-09-29
- Primary completion
- 2017-06-19
- Completion
- 2017-12-04
- First posted
- 2015-07-17
- Last updated
- 2021-11-09
- Results posted
- 2018-09-13
Locations
127 sites across 17 countries: United States, Argentina, Australia, Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02501629. Inclusion in this directory is not an endorsement.