Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03706079|
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Biological: Tezepelumab Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||950 participants|
|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)|
|Official Title:||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)|
|Actual Study Start Date :||January 7, 2019|
|Estimated Primary Completion Date :||September 29, 2021|
|Estimated Study Completion Date :||May 24, 2022|
Tezepelumab subcutaneous injection
Tezepelumab subcutaneous injection
Placebo Comparator: Placebo
Placebo: Placebo subcutaneous injection
Placebo subcutaneous injection
- Exposure adjusted incidence rates of AEs/SAEs [ Time Frame: Baseline (Week 0 in predecessor study) to Week 104 ]Exposure adjusted rates defined as the number of events divided by person-time at risk
- Annualized asthma exacerbation rate (AAER) [ Time Frame: Baseline (Week 0 in predecessor study) to Week 104 ]The annualized exacerbation rate is based on exacerbations reported by the investigator in the eCRF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706079
|Principal Investigator:||Andrew Menzies-Gow, MD||Royal Brompton Hospital, United Kingdom|