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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID: NCT03706079
Run by: AstraZeneca
People needed: 951
Starts: 2019-01-07
Expected to finish: 2022-05-18
Last updated by the study team: 2023-06-06

Who can join

Age: 13 and older, up to 81. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Research Site — Gilbert, Arizona, United States
Research Site — Bakersfield, California, United States
Research Site — Huntington Beach, California, United States
Research Site — Long Beach, California, United States
Research Site — Los Angeles, California, United States
Research Site — Newport Beach, California, United States
Research Site — Northridge, California, United States
Research Site — Palm Desert, California, United States
Research Site — Rolling Hills Estates, California, United States
Research Site — Walnut Creek, California, United States
Research Site — Westminster, California, United States
Research Site — New Haven, Connecticut, United States
Research Site — Kissimmee, Florida, United States
Research Site — Kissimmee, Florida, United States
Research Site — Port Charlotte, Florida, United States
Research Site — Sarasota, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Winter Park, Florida, United States
Research Site — Boise, Idaho, United States
Research Site — Zachary, Louisiana, United States
Research Site — White Marsh, Maryland, United States
Research Site — Boston, Massachusetts, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — St Louis, Missouri, United States
Research Site — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.