Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Enrolling by invitation
First Posted : October 15, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Asthma Biological: Tezepelumab Other: Placebo Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 964 participants
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
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 : December 22, 2021
Estimated Study Completion Date : December 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Tezepelumab
Tezepelumab subcutaneous injection
Biological: Tezepelumab
Tezepelumab subcutaneous injection

Placebo Comparator: Placebo
Placebo: Placebo subcutaneous injection
Other: Placebo
Placebo subcutaneous injection




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 81 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Males who are sexually active with a female partner of childbearing potential must use a male condom plus spermicide from Day 1 through 16 weeks after 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
  • Resection or treatment of in situ carcinoma of cervix during the 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

Information from the National Library of Medicine

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


  Show 150 Study Locations
Sponsors and Collaborators
AstraZeneca
Amgen
Investigators
Layout table for investigator information
Principal Investigator: Andrew Menzies-Gow, MD Royal Brompton Hospital, United Kingdom

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03706079     History of Changes
Other Study ID Numbers: D5180C00018
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

Layout table for additional information
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

Keywords provided by AstraZeneca:
Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases