Tezepelumab COPD Exacerbation Study (COURSE)

February 17, 2025 updated by: AstraZeneca

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)

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, 338 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
337

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Research Site
      • Quebec, Canada, G3K 2P8
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Research Site
      • Sherwood Park, Alberta, Canada, T8L 0N2
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Research Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada, B2N 1L2
        • Research Site
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
        • Research Site
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Research Site
    • Quebec
      • Montréal, Quebec, Canada, H1M 1B1
        • Research Site
      • St Charles Borromee, Quebec, Canada, J6E 2B4
        • Research Site
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Research Site
  • Denmark
      • Aarhus N, Denmark, 8200
        • Research Site
      • Hvidovre, Denmark, 2650
        • Research Site
      • København NV, Denmark, 2400
        • Research Site
      • Odense C, Denmark, 5000
        • Research Site
      • Roskilde, Denmark, 4000
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
      • Ålborg, Denmark, 9000
        • Research Site
  • France
      • Amiens Cedex 1, France, 80054
        • Research Site
      • Brest Cedex 2, France, 29609
        • Research Site
      • Grenoble Cedex, France, 38043
        • Research Site
      • Lyon Cedex 04, France, 69317
        • Research Site
      • Marseille, France, 13015
        • Research Site
      • Montpellier, France, 34090
        • Research Site
      • Nantes Cedex 1, France, 44093
        • Research Site
  • Germany
      • Berlin, Germany, 12203
        • Research Site
      • Frankfurt, Germany, 60596
        • Research Site
      • Grosshansdorf, Germany, 20927
        • Research Site
      • Lübeck, Germany, 23552
        • Research Site
      • Mainz, Germany, 55131
        • Research Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Research Site
      • Beer Sheva, Israel, 84101
        • Research Site
      • Haifa, Israel, 34362
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Jerusalem, Israel, 91120
        • Research Site
      • Kfar Saba, Israel, 49281
        • Research Site
      • Rehovot, Israel, 7661041
        • Research Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42415
        • Research Site
      • Incheon, Korea, Republic of, 21431
        • Research Site
      • Jeonju-si, Korea, Republic of, 54907
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
      • Seoul, Korea, Republic of, 03312
        • Research Site
      • Seoul, Korea, Republic of, 05030
        • Research Site
      • Seoul, Korea, Republic of, 06973
        • Research Site
      • Uijeongbu-si, Korea, Republic of, 11765
        • Research Site
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Research Site
      • Heerlen, Netherlands, 6419 PC
        • Research Site
      • Rotterdam, Netherlands, 3045 PM
        • Research Site
      • Rotterdam, Netherlands, 3083 AN
        • Research Site
      • Zutphen, Netherlands, 7207 AE
        • Research Site
  • Spain
      • Alzira, Spain, 46410
        • Research Site
      • Barcelona, Spain, 08025
        • Research Site
      • Granada, Spain, 18014
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Mérida (Badajoz), Spain, 06800
        • Research Site
  • United Kingdom
      • Bradford, United Kingdom, BND9 6RJ
        • Research Site
      • Chertsey, United Kingdom, KT16 0PZ
        • Research Site
      • Cottingham, United Kingdom, HU16 5JQ
        • Research Site
      • Glasgow, United Kingdom, G12 0YN
        • Research Site
      • London, United Kingdom, SW10 9NH
        • Research Site
      • Newcastle-upon-Tyne, United Kingdom, NE1 4LP
        • Research Site
      • Wakefield, United Kingdom, WF1 4DG
        • Research Site
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Research Site
    • California
      • Huntington Beach, California, United States, 92647
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Upland, California, United States, 91786
        • Research Site
      • Westminster, California, United States, 92683
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Research Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Research Site
      • Orlando, Florida, United States, 32819
        • Research Site
      • Panama City, Florida, United States, 32405
        • Research Site
      • Tampa, Florida, United States, 33607
        • Research Site
      • Winter Park, Florida, United States, 32789-4681
        • Research Site
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Research Site
      • Mooresville, North Carolina, United States, 28117
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Research Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
      • Rock Hill, South Carolina, United States, 29732
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Texas
      • McKinney, Texas, United States, 75069
        • Research Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Research Site
    • Washington
      • Everett, Washington, United States, 98208
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic 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.
  3. Major surgery within 8 weeks before enrollment.
  4. History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
  5. Pregnant or breastfeeding.
  6. The chest/lungs with pathology that precludes the patient's ability to complete the study
  7. The patient has active COVID 19 infection during screening period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Tezepelumab
Tezepelumab, SC, Q4W
Biological: Tezepelumab
Tezepelumab subcutaneous injection
Placebo Comparator: Matching Placebo
Matching placebo, SC, Q4W
Other: Placebo
Placebo subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD.
Time Frame: From randomisation up to Week 52

A COPD exacerbation was defined as a change in the participant's usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days, and may warrant a change in regular medication and leads to any of the following: Use of systemic corticosteroids for at least 3 days, use of antibiotics for at least 3 days, an inpatient hospitalisation due to COPD, or results in death.

Analysis was done using a negative binomial model with the response variable as the number of COPD exacerbations experienced during the follow-up for exacerbations. The model included covariates of treatment group, region, and number of exacerbations reported at randomisation as recorded in IWRS (2, >=3). The logarithm of the time at risk (in years) for exacerbation in the study is used as an offset variable.
From randomisation up to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to First Moderate/Severe COPD Exacerbation
Time Frame: From randomisation up to Week 52
Time to first moderate/severe COPD exacerbation post-randomisation, presented as number of subjects with at least one moderate/severe COPD exacerbation.
From randomisation up to Week 52
Proportion of Participants COPD Exacerbation Free at Week 52
Time Frame: From randomisation up to Week 52
An exacerbation event was defined as described in primary analysis. A participant was exacerbation free if they did not experience any moderate or severe exacerbations from randomisation to Week 52 (EOT).
From randomisation up to Week 52
Comparison of Annual Severe COPD Exacerbation Rates Over 52 Weeks
Time Frame: From randomisation up to Week 52
An exacerbation was considered severe if it results in at least 1 of the following: Hospitalisation due to the COPD exacerbation (defined as a participant being admitted for ≥ 24 hours to an observation area, the emergency department, or other equivalent healthcare facility), or death related to COPD or COPD exacerbation.
From randomisation up to Week 52
Proportion of Participants With >=1 Severe COPD Exacerbations Over 52 Weeks
Time Frame: From randomisation up to Week 52
An exacerbation was considered severe if it results in at least 1 of the following: Hospitalisation due to the COPD exacerbation (defined as a participant being admitted for ≥ 24 hours to an observation area, the emergency department, or other equivalent healthcare facility), or death related to COPD or COPD exacerbation.
From randomisation up to Week 52
Time to First Severe COPD Exacerbation
Time Frame: From randomisation up to Week 52
Time to first severe COPD exacerbation post-randomisation, presented as number of subjects with at least one severe COPD exacerbation.
From randomisation up to Week 52
Least Square (LS) Mean Difference in Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 (FEV1) at Week 52
Time Frame: Baseline and Week 52

Pre-Bronchodilator FEV1 (L) was determined by spirometry at the clinic visit. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

Change from baseline was obtained as an absolute difference between Week 52 measure and the baseline value.

Baseline was defined as the last assessment recorded prior to the first dose of study treatment.
Baseline and Week 52
Lease Square (LS) Mean Difference in Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Time Frame: Baseline and Week 52

The SGRQ is a 50-item PRO instrument to measure the health status of participants with airway obstruction diseases. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status.

Baseline is the measurement recorded at Week 0 (Visit 3).
Baseline and Week 52
Proportion of Participants Achieving a Minimum Clinically Important Difference of 4 Units or More in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Time Frame: Baseline and Week 52

The SGRQ is a 50-item PRO instrument to measure the health status of participants with airway obstruction diseases. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status.

A responder was defined as an individual who had "improvement" at Week 52 (>=4 point decrease in SGRQ total score).
Baseline and Week 52
Least Square (LS) Mean Difference in Change From Baseline in COPD Assessment Tool (CAT) Total Score at Week 52
Time Frame: Baseline and Week 52

The CAT is an 8-item PRO developed to measure the impact of COPD on health status. A CAT total score is the sum of item responses. Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

Baseline was defined as the value at the randomisation visit (Visit 3). If the Visit 3 measurement was missing, the screening value was used as baseline instead.
Baseline and Week 52
Serum Concentration of Tezepelumab
Time Frame: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled

Blood samples were collected to determine the serum concentration of Tezepelumab.

With the exception of Week 0 and Week 64, only pre-dose data from samples collected between 21 and 35 days after previous dose of investigational product were included.
Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled
Number of Participants With Anti-Drug Antibody (ADA) Response to Tezepelumab
Time Frame: Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled
Blood samples were measured for the presence of ADAs for tezepelumab using validated assays. Treatment-induced ADA positive was defined as ADA negative at baseline and post-baseline ADA positive. Treatment-boosted ADA positive was defined as baseline positive ADA titre that was boosted to a 4 fold or higher level following IP administration. TE-ADA positive was defined as the sum of treatment-induced ADA positive and treatment-boosted ADA positive. ADA incidence is the proportion of TE-ADA positive subjects in a population. ADA persistently positive was defined as ADA positive at >= 2 post-baseline assessments or ADA positive at last post-baseline assessment. ADA transiently positive was defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of ADA persistently positive. Treatment-induced nAb positive was defined as nAb negative or ADA negative at baseline and nAb positive at any post-baseline visit.
Pre-dose at weeks 0, 4, 12, 24, 36 and also at weeks 52 and 64 where no dosing was scheduled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dave Singh, MD, Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5241C00001
  • 2019-001363-67 (EudraCT Number)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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