CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 177 enrolled
Drug / intervention
Reslizumab +3 moredrug
Likely dose
Reslizumab 110 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02501629
NCT02501629Phase 3Completed
CompareCT.gov

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

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jul 17, 2015·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Reslizumab, Placebo, and 2 other interventions for Asthma and 2 related conditions. Completed, enrolled 177 participants across 127 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Elevated Blood Eosinophils, Oral Corticosteroid Dependence
CountriesArgentina, Australia, Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Korea, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 17, 2015
Enrollment StartSep 29, 2015
Primary CompletionJun 19, 2017
Study CompletionDec 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.0 years ago

Interventions

Reslizumabdrug

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.

Placebodrug

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.

Non-Oral Corticosteroid (non-OCS) Asthma Medicationdrug

Participants continue using their non-OCS background asthma medications without change during the study's treatment period.

Oral Corticosteroid (OCS)drug

After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.