Study identifier:D5180C00018
ClinicalTrials.gov identifier:NCT03706079
EudraCT identifier:N/A
CTIS identifier:N/A
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)
asthma
Phase 3
No
-
All
951
Interventional
13 Years - 81 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2023 by AstraZeneca
AstraZeneca
Amgen
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.
Location
Location
Las Vegas, NV, United States, 89119
Location
Moscow, Russian Federation, 115522
Location
Moscow, Russian Federation, 115093
Location
Izhevsk, Russian Federation, 426035
Location
St-Petersburg, Russian Federation, 193231
Location
Kharkiv region, Ukraine, 61075
Location
Ivano-Frankivsk, Ukraine, 76018
Location
Windsor, ON, Canada, N8X 1T3
Arms | Assigned Interventions |
---|---|
Experimental: Tezepelumab Tezepelumab subcutaneous injection | Biological/Vaccine: Tezepelumab Tezepelumab subcutaneous injection Other Name: Tezepelumab |
Placebo Comparator: Placebo Placebo: Placebo subcutaneous injection | Other: Placebo Placebo subcutaneous injection Other Name: Placebo |
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