MedTrace Logo

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

NCT03052725 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2022-12-14

Study results available
· View outcomes & findings →

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

  • Eosinophils, Asthma

Interventions

DRUG

reslizumab

Reslizumab was provided in a pre-filled syringe.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2018-02-22
Completion
2018-02-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052725 on ClinicalTrials.gov