Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Tezepelumab; Placebo
Intervention description: Tezepelumab subcutaneous injection; Placebo subcutaneous injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects previously randomized in one of the predecessor studies to tezepelumab will be assigned and remain on tezepelumab dosing in the Destination Study.
Subjects randomized to placebo arm in the predecessor studies will be re-randomized in a 1:1 ratio to either tezepelumab or placebo.
Given the randomization scheme of subjects in the predecessor studies, this will give an overall subject distribution of 3:1 (tezepelumab:placebo), assuming a similar number of subjects rollover from each arm in the predecessor studies.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-Blind
Enrollment: 951.0
Sex: All
Minimum age: 13 Years
Maximum age: 81 Years
Healthy volunteers: No
Keywords: Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Summary:

      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.
    

Eligibility criteria:

        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.