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Tezepelumab COPD Exacerbation Study (COURSE)

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ClinicalTrials.gov Identifier: NCT04039113
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Biological: Tezepelumab Other: Placebo Phase 2

Detailed Description:
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving triple inhaled maintenance therapy, and having had 2 or more documented COPD exacerbations in the 12 months prior to Visit 1. Approximately, 282 subjects will be randomized globally. Subjects will be stratified by region and prior number of exacerbations (2 vs. 3 or more). Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : February 14, 2022
Estimated Study Completion Date : May 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Tezepelumab
Tezepelumab, SC, Q4W
Biological: Tezepelumab
Tezepelumab subcutaneous injection

Placebo Comparator: Matching Placebo
Matching placebo, SC, Q4W
Other: Placebo
Placebo subcutaneous injection




Primary Outcome Measures :
  1. Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo) [ Time Frame: Over 52 Weeks ]
    The exacerbation rate is based on exacerbations reported by the investigator over 52 weeks.


Secondary Outcome Measures :
  1. Time to first moderate or severe COPD exacerbation [ Time Frame: By Week 52 ]
    Time to first occurrence of moderate/severe exacerbation post randomization. Outcome measures: Hazard ratio

  2. Proportion with at least one moderate/severe COPD exacerbation [ Time Frame: Over 52 Weeks ]
    Proportion of subjects with at least one moderate/severe exacerbation reported by the Investigator over 52 weeks Outcome measure: Odds Ratio

  3. Severe COPD exacerbation rate ratio (tezepelumab vs. placebo) [ Time Frame: Over 52 Weeks ]
    The severe exacerbation rate is based on severe exacerbations reported by the Investigator over 52 weeks.

  4. Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) [ Time Frame: Baseline, Week 52 ]

    Difference in change from baseline in pre-BD forced expiratory volume in 1 second (FEV1) in tezepelumab arm as compared to placebo at Week 52.

    FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration.


  5. Change in respiratory health status/health-related quality of life [ Time Frame: Baseline, Week 52 ]

    Proportion of subjects achieving a decrease of 4 units or more in the St. George's Respiratory Questionnaire (SGRQ) total score at Week 52, i.e. minimum clinically important difference (MCID).

    Outcome measure: odds ratio


  6. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: Baseline, Week 52 ]

    Difference (tezepelumab vs. placebo) in SGRQ from baseline at Week 52.

    SGRQ is a 50-item patient reported outcome questionnaire. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0% indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment. Decrease of 4 units is associated with a minimum clinically important difference (MCID).


  7. Change from baseline in the COPD Assessment Test (CAT) Total Score [ Time Frame: Baseline, Week 52 ]

    Difference (tezepelumab vs. placebo) in COPD assessment tool (CAT) from baseline at Week 52.

    CAT is an 8-item patient reported outcome questionnaire developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. The score ranges from 0 to 40, with higher scores indicating greater COPD impact on health status.


  8. Evaluate pharmacokinetics of tezepelumab [ Time Frame: Weeks 0, 4, 12, 24, 36, 52, 64 ]
    Serum trough concentration of tezepelumab

  9. Evaluate immunogenicity of tezepelumab [ Time Frame: Over 52 weeks ]
    Incidence of anti-drug antibodies (ADA)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
  2. History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
  3. CAT score of ≥15 at enrollment and on day of randomization.
  4. Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment.

Exclusion Criteria:

  1. Pulmonary disease other than COPD (including current or previous asthma diagnosis)
  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.

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): NCT04039113


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 67 Study Locations
Sponsors and Collaborators
AstraZeneca
Amgen
Investigators
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Principal Investigator: Dave Singh, MD Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04039113     History of Changes
Other Study ID Numbers: D5241C00001
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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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:
COPD
Moderate COPD
Severe COPD
chronic obstructive pulmonary disease
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs