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
Overview
- Phase
- Phase 3
- Intervention
- Reslizumab
- Conditions
- Eosinophilic Asthma
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 1052
- Locations
- 219
- Primary Endpoint
- Participants With Treatment-Emergent Adverse Events
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief 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.
Detailed Description
Study patients 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent is obtained.
- •Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
- •The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- •other criteria may apply; please contact the investigator for more information.
Exclusion Criteria
- •The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
- •The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
- •The patient is a current smoker.
- •The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
- •The patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease \[GERD\]).
- •Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device \[IUD\], or steroidal contraceptive \[oral, transdermal, implanted, and injected\] in conjunction with a barrier method) are excluded from this study.
- •The patient has a current infection or disease that may preclude assessment of asthma.
- •other criteria may apply; please contact the investigator for more information.
Arms & Interventions
Reslizumab 3.0 mg/kg
Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Intervention: Reslizumab
Outcomes
Primary Outcomes
Participants With Treatment-Emergent Adverse Events
Time Frame: Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values
Time Frame: Weeks 4, 8, 24 and 48
Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses. Significance criteria: * Blood urea nitrogen: \>=10.71 mmol/L * Creatinine: \>=177 μmol/L * Uric acid: M\>=625, F\>=506 μmol/L * Aspartate aminotransferase: \>=3\*upper limit of normal (ULN). Normal range is 10-43 U/L * Alanine aminotransferase: \>=3\*ULN. Normal range is 10-40 U/L * GGT = gamma-glutamyl transpeptidase: \>= 3\*upper limit of normal. Normal range is 5-49 U/L. * Total bilirubin: \>=34.2 μmol/L * White blood cells- low: \<=3.0\*10\^9/L * White blood cells-high: \>=20\*10\^9/L * Hemoglobin: M\<=115, F\<=95 g/dL * Hematocrit: M\<0.37, F\<0.32 L/L * Platelets: \>=700\*10\^9/L * Absolute neutrophil count: \<=1.0\*10\^9/L * Eosinophils: \>=10 * Urinalysis: ketones, blood, glucose, and total protein: \>=2 unit increase from baseline
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values
Time Frame: Week 4 to Week 65
Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit. Significance criteria * Sitting heart rate-high: \>100 and increase of \>= 30 beats/min (all ages) * Sitting heart rate-low: \<50 and decrease of \>=30 beats/min * Sitting systolic blood pressure (BP)-high: \>130 and increase of \>=30 mmHg (ages 12-17) * Systolic BP-low: \<90 and decrease of \>=30 mmHg (ages \>=18) * Systolic BP-high: \>160 and increase of \>=30 mmHg (ages \>=18) * Sitting diastolic BP-low: \<55 and decrease of \>=12 mmHg (ages 12-17) * Diastolic BP-high: \>85 and increase of \>=12 mmHg (ages 12-17) * Diastolic BP-low: \<50 and decrease of \>=12 mmHg (ages \>=18) * Diastolic BP-high: \>100 and increase of \>=12 mmHg (ages \>=18) * Respiration rate: \>20 and increase of \>=10 breaths/minute (ages 12-17) * Respiration rate: \>24 and increase of \>=10 breaths/minute (ages \>=18) * Body temperature-low: \<96.5° Fahrenheit (all ages) * Body temp-high: \>100.5° F (all ages)
Secondary Outcomes
- Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint(Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint)
- Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint(Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint)
- Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint(Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint)
- Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint(Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint)
- Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint(Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint)
- Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint(Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint)
- Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint(Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint)
- Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint(Weeks 24, 48, 72, 96, End of Study and Endpoint)
- Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall(Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall)