A Phase 3 extension study designed to evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with severe, uncontrolled asthma on Inhaled Corticosteroids and at least one additional asthma controller

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 975

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 to informed consent, as well
as assent by adolescent subjects where applicable, prior to any
mandatory study specific procedures, sampling and analyses for
Extended Follow Up.
5) Subjects who rollover from D5180C00007 study and in DESTINATION
have completed IP dosing to Week 100, have not met IP Discontinuation criteria and have attended the study EOT Visit.
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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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