Clinical Trials Logo
  1. Home
  2. Eosinophilic Asthma
  3. 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

Eosinophilic Asthma Clinical Trial

Official title:
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

Clinical Trial Summary

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

Clinical Trial Description

Study patients were deemed eligible based on activities from the preceding Teva sponsored double blind study of reslizumab in eosinophilic asthma. Specifically, as per inclusion criterion c, patients must have either completed treatment in a previous Teva-sponsored study or have received at least 2 doses of study drug treatment in a pulmonary function study.

Eligible patients could enroll in this study only after completion of the end of treatment visit in a Teva sponsored, randomized, placebo controlled, double blind study of reslizumab in eosinophilic asthma, which served as the screening/baseline visit for participation in this open label extension study. The use of systemic corticosteroids for asthma in any of the previous Teva sponsored double blind studies of reslizumab did not exclude patients from this study. The previous Teva studies were C38072/3081 (NCT01270464), C38072/3082 (NCT01287039), and C38072/3083 (NCT01285323). ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01290887
Study type Interventional
Source Teva Pharmaceutical Industries
Contact
Status Terminated
Phase Phase 3
Start date June 2011
Completion date January 2015
View Details
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
Recruiting NCT04228588 - A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil Phase 4
Recruiting NCT05763121 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. Phase 3
Recruiting NCT05748600 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With 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
Completed NCT04046939 - Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma Phase 2