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
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.
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).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
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
|
||
Completed |
NCT04046939 -
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
|
Phase 2 |