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A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

NCT01287039 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 489

Last updated 2021-11-09

Study results available
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Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and immunogenicity of treatment with reslizumab in patients with eosinophilic asthma.

Conditions

Interventions

DRUG

Reslizumab

Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.

DRUG

Placebo

Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • United States
  • Australia
  • Belgium
  • Chile
  • Colombia
  • Czechia
  • Denmark
  • Hungary
  • Israel
  • Malaysia
  • New Zealand
  • Philippines
  • Poland
  • Russia
  • South Africa
  • Sweden
  • Thailand

Study Locations

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Entities

Drugs
Diseases

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 NCT01287039 on ClinicalTrials.gov