CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 511 enrolled
Drug / intervention
Reslizumab +1 moredrug
Likely dose
Reslizumab 3.0 mg/kgfrom 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/NCT01508936
NCT01508936Phase 3Completed
CompareCT.gov

A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jan 12, 2012·Updated Jun 27, 2016

In Brief

A Phase 3 clinical trial evaluating Reslizumab and Placebo for Eosinophilic Asthma. Completed, enrolled 511 participants across 66 sites.

Detailed Summary

The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to baseline blood eosinophil levels in patients with moderate to severe asthma, as assessed by the change from baseline to week 16 in forced expiratory volume in 1 second (FEV1).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Asthma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2012
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.5 years ago

Interventions

Reslizumabdrug

Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).

Placebodrug

Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).