Severe Uncontrolled Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provision of signed and dated informed consent form prior to any mandatory study specific procedures, sampling and analysis. 2) Negative urine pregnancy test for female subjects of childbearing potential prior to administration of IP at visit 1. 3) Subjects who have not met investigational product discontinuation criteria and have attended the EOT visit in either predecessor study D5180C00007 or D5180C00009. To enter the extended follow-up phase of the study, the following inclusion criteria also apply: 4) Provision of signed and dated Addendum for Extended Follow-up to Informed Consent, as well as assent by adolescent subjects where applicable, prior to any mandatory study-specific procedures, sampling and analyses before Extended Follow Up. 5) Subjects who rollover from D5180C00007 study and have completed IP dosing to week 100 in study D5180C00018, have not IP discontinuation criteria and have attended the study EOT visit. Note: If a subject is not able to attend an on-site EOT visit (Week 104) due to COVID-19, they may still participate in the Extended Follow-Up. Are the trial subjects under 18? yes Number of subjects for this age range: 65 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 785 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: 1) Any clinically important pulmonary disease other than asthma 2) Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator 3) Any history of chronic alcohol or drug abuse within 12 months prior to Visit 1 4) Current malignancy or malignancy that developed during a predecessor study 5) Treatment with the following medications within the last 12 weeks prior to randomization: Systemic immunosuppressive/immunomodulating drugs except for OCS used for the treatment of asthma 6) Any important protocol deviations in either of the predecessor studies 7) Pregnant, breastfeeding, or lactating women To enter the extended follow-up phase of the study, the following exclusion criteria also apply: 8) Discontinuation of IP during the treatment period of DESTINATION. 9) Entered DESTINATION from D5180C00009 (SOURCE) study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of Tezepelumab in severe asthma subjects;Secondary Objective: To assess the long-term effect of 210 mg Tezepelumab SC Q4W on asthma exacerbations in adult and adolescent subjects with severe uncontrolled asthma compared with placebo;Primary end point(s): Exposure adjusted incidence rates of AEs/SAEs;Timepoint(s) of evaluation of this end point: Baseline (Week 0 in predecessor study) to 104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Annualized asthma exacerbation rate (AAER);Timepoint(s) of evaluation of this end point: Baseline (Week 0 in predecessor study) to 104 weeks | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, France, Germany, Israel, Korea, Republic of, Poland, Russian Federation, Saudi Arabia, South Africa, Taiwan, Turkey, Ukraine, United States, Vietnam
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed