Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to
 consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group,
 Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in
 Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment
 phase, followed by a follow-up phase where subjects will not receive IP. The length of the
 follow up phase is determined by which study the subject had previously completed.
Subjects who have not met investigational product discontinuation criteria and have attended
 the EOT visit in either study D5180C00007 or D5180C00009 will be offered the opportunity to
 consent for the Multicentre, Double-blind, Randomized, Parallel Group, Placebo Controlled,
 Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab versus
 placebo in Adults and Adolescents (12 years of age and older) with a history of asthma
 exacerbations and inadequately controlled severe asthma receiving medium or high dose inhaled
 corticosteroid (ICS) plus at least one additional asthma controller medication with or
 without oral corticosteroids

 Following treatment, subjects will enter a follow-up phase, determined by the predecessor
 study they had previously completed. Subjects will not receive IP during the follow-up phase.
 For subjects who entered the study from study D5180C00007 and did not meet IP Discontinuation
 criteria, the follow-up phase will extend from week 104 to Week 140. Subjects who entered the
 study from study D5180C00009 will have their follow-up phase extend to week 116.
Inclusion Criteria:

 -  Provision of signed and dated written informed consent

 -  Negative urine test for female subjects of childbearing potential prior to
 administration of IP at visit 1

 -  Females of childbearing potential who are sexually active with a nonsterilized male
 partner must use a highly effective method of contraception from screening, and must
 agree to continue using such precautions for 16 weeks after the final dose of IP.

 -  Female or male subjects who have not met investigational product discontinuation
 criteria and have attended the EOT visit in either study D5180C00007 (NAVIGATOR) or
 D5180C00009 (SOURCE)

 To enter the extended follow-up phase of the study, the following inclusion criteria also
 apply:

 -  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.

 -  Must have entered DESTINATION from D5180C00007 study and have completed IP dosing to
 Week 100, have not met IP Discontinuation criteria and have attended the EOT Visit.

 Exclusion Criteria:

 -  Any clinically important pulmonary disease other than asthma

 -  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

 -  History of chronic alcohol or drug abuse within 12 months prior to visit 1

 -  Current malignancy or malignancy that developed during a predecessor study

 -  Major surgery or planned surgical procedures requiring general anesthesia or inpatient
 status for > 1 day during the conduct of the study

 -  Treatment with systemic immunosuppressive/immunomodulating drugs except for OCS used
 in the treatment of asthma/asthma exacerbations within the last 12 weeks prior to
 randomization

 -  Concurrent enrolment in another clinical study involving an IP

 -  Any clinically meaningful abnormal finding in physical examination, vital signs,
 ECG,haematology, clinical chemistry, or urinalysis during the predecessor study

 -  Pregnant, breastfeeding, or lactating

 To enter the extended follow-up phase of the study (which extends from week 104 to week
 140), the following exclusion criteria also apply:

 -  Discontinuation of IP during the treatment period of DESTINATION.

 -  Entered DESTINATION from D5180C00009 (SOURCE) study.