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

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ClinicalTrials.gov Identifier: NCT03706079
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 15, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE January 7, 2019
Estimated Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
Exposure adjusted 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03706079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
Official Title  ICMJE 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)
Brief 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
Detailed Description 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Biological: Tezepelumab
    Tezepelumab subcutaneous injection
  • Other: Placebo
    Placebo subcutaneous injection
Study Arms  ICMJE
  • Experimental: Tezepelumab
    Tezepelumab subcutaneous injection
    Intervention: Biological: Tezepelumab
  • Placebo Comparator: Placebo
    Placebo: Placebo subcutaneous injection
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
966
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2018)
975
Estimated Study Completion Date  ICMJE March 25, 2022
Estimated Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 81 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Brazil,   Canada,   France,   Germany,   Israel,   Korea, Republic of,   Poland,   Russian Federation,   South Africa,   Taiwan,   Turkey,   Ukraine,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706079
Other Study ID Numbers  ICMJE D5180C00018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Amgen
Investigators  ICMJE
Principal Investigator: Andrew Menzies-Gow, MD Royal Brompton Hospital, United Kingdom
PRS Account AstraZeneca
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP