Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Demonstrate the efficacy of reslizumab, at a dose of 3 mg/kg administered iv every 4 weeks over 12 months, as assessed by the reduction in frequency of clinical asthma exacerbations (CAEs) during 12 months. An exacerbation event will be considered a CAE if the patient meets either or both of the criteria listed below and this is corroborated with at least 1 other measurement to indicate the worsening of clinical signs and symptoms of asthma: - use of systemic, or an increase in the use of inhaled, corticosteroid treatment for 3 or more days - asthma-related emergency treatment The above criteria must be corroborated with at least 1 other measurement to indicate worsening in the clinical signs and symptoms of asthma. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01287039
Study type Interventional
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact
Status Completed
Phase Phase 3
Start date April 2011
Completion date March 2014

See also
  Status Clinical Trial Phase
Recruiting NCT05398133 - Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma
Recruiting NCT04585997 - Comparing Treatment Efficacy With Mepolizumab and Omalizumab in Severe Asthma - "Choosebetweenamab". Phase 4
Recruiting NCT05985694 - AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma Phase 2
Completed NCT03563521 - Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma
Completed NCT03469934 - Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma Phase 2
Enrolling by invitation NCT06388889 - Phase III Long-Term Extension Study With Dexpramipexole Phase 3
Recruiting NCT04187976 - Eosinophils Endotypes in Chronic Airway Inflammatory Diseases
Recruiting NCT05813288 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3) Phase 3
Completed NCT01285323 - A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma Phase 3
Completed NCT03696914 - Intense Airway Eosinophilia in Asthma
Terminated NCT01290887 - Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma Phase 3
Recruiting NCT04228588 - A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil Phase 4
Recruiting NCT05748600 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma Phase 3
Recruiting NCT05763121 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. Phase 3
Completed NCT01508936 - Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma Phase 3
Recruiting NCT04538937 - Prospective Registry of Eosinophilia With Respiratory Manifestations With Translational Research Identifying and Characterizing Eosinophils
Completed NCT05002621 - Changes in Gene Transcription and Immunophenotypes Following Mepolizumab Treatment for Asthma
Completed NCT01270464 - A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma Phase 3
Completed NCT04674137 - XC8 in the Treatment of Patients With the Eosinophilic Phenotype of Bronchial Asthma Phase 2
Recruiting NCT04671446 - Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma