Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma



Status:Enrolling by invitation
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:13 - 81
Updated:3/27/2019
Start Date:January 7, 2019
End Date:December 22, 2021

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A 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 (DESTINATION)

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

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 verses
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

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.

- Males who are sexually active with a female partner of childbearing potential must use
a male condom plus spermicide from Day 1 through 16 weeks after 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)

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

- Resection or treatment of in situ carcinoma of cervix during the 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
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