Clinical Trials Directory

Trials / Terminated

TerminatedNCT03052725

A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
391 (actual)
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

Summary

This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.

Conditions

Interventions

TypeNameDescription
DRUGreslizumabReslizumab was provided in a pre-filled syringe.

Timeline

Start date
2017-03-10
Primary completion
2018-02-22
Completion
2018-02-22
First posted
2017-02-14
Last updated
2022-12-14
Results posted
2019-03-21

Locations

134 sites across 13 countries: United States, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Poland, Romania, Russia, Spain, Ukraine

Regulatory

Source: ClinicalTrials.gov record NCT03052725. Inclusion in this directory is not an endorsement.