Tezepelumab COPD Exacerbation Study

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COURSE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039113
• Other study ID #: D5241C00001
• Secondary ID: 2019-001363-67
• Status: Completed
• Phase: Phase 2
• Start date: July 30, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: January 31, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• Tezepelumab
Tezepelumab subcutaneous injection

Other:
• Placebo
Placebo subcutaneous injection

Locations

Country	Name	City	State
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Montréal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Sherwood Park	Alberta
Canada	Research Site	St Charles Borromee	Quebec
Canada	Research Site	Trois-Rivières	Quebec
Canada	Research Site	Truro	Nova Scotia
Canada	Research Site	Vancouver	British Columbia
Denmark	Research Site	Aarhus N
Denmark	Research Site	Ålborg
Denmark	Research Site	Hvidovre
Denmark	Research Site	København NV
Denmark	Research Site	Odense C
Denmark	Research Site	Roskilde
Denmark	Research Site	Vejle
France	Research Site	Amiens Cedex 1
France	Research Site	Brest Cedex 2
France	Research Site	Grenoble Cedex
France	Research Site	Lyon Cedex 04
France	Research Site	Marseille
France	Research Site	Montpellier
France	Research Site	Nantes Cedex 1
Germany	Research Site	Berlin
Germany	Research Site	Frankfurt
Germany	Research Site	Grosshansdorf
Germany	Research Site	Lübeck
Germany	Research Site	Mainz
Israel	Research Site	Ashkelon
Israel	Research Site	Beer Sheva
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar Saba
Israel	Research Site	Rehovot
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeonju-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Uijeongbu-si
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Rotterdam
Netherlands	Research Site	Zutphen
Spain	Research Site	Alzira
Spain	Research Site	Barcelona
Spain	Research Site	Granada
Spain	Research Site	Málaga
Spain	Research Site	Mérida (Badajoz)
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Chertsey
United Kingdom	Research Site	Cottingham
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	London
United Kingdom	Research Site	Newcastle-upon-Tyne
United Kingdom	Research Site	Wakefield
United States	Research Site	Abingdon	Virginia
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Brandon	Florida
United States	Research Site	Buckley	Michigan
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Columbus	Ohio
United States	Research Site	Dothan	Alabama
United States	Research Site	Edmond	Oklahoma
United States	Research Site	Everett	Washington
United States	Research Site	Huntington Beach	California
United States	Research Site	McKinney	Texas
United States	Research Site	Medford	Oregon
United States	Research Site	Mooresville	North Carolina
United States	Research Site	Mount Pleasant	South Carolina
United States	Research Site	New Bern	North Carolina
United States	Research Site	New Haven	Connecticut
United States	Research Site	Newport Beach	California
United States	Research Site	Orlando	Florida
United States	Research Site	Panama City	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Rock Hill	South Carolina
United States	Research Site	Tampa	Florida
United States	Research Site	Upland	California
United States	Research Site	Westminster	California
United States	Research Site	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Amgen

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Germany,  Israel,  Korea, Republic of,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo)	The exacerbation rate is based on exacerbations reported by the investigator over 52 weeks.	Over 52 Weeks
Secondary	Time to first moderate or severe COPD exacerbation	Time to first occurrence of moderate/severe exacerbation post randomization. Outcome measures: Hazard ratio	By Week 52
Secondary	Proportion with at least one moderate/severe COPD exacerbation	Proportion of subjects with at least one moderate/severe exacerbation reported by the Investigator over 52 weeks Outcome measure: Odds Ratio	Over 52 Weeks
Secondary	Severe COPD exacerbation rate ratio (tezepelumab vs. placebo)	The severe exacerbation rate is based on severe exacerbations reported by the Investigator over 52 weeks.	Over 52 Weeks
Secondary	Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)	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.	Baseline, Week 52
Secondary	Change in respiratory health status/health-related quality of life	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	Baseline, Week 52
Secondary	Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score	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).	Baseline, Week 52
Secondary	Change from baseline in the COPD Assessment Test (CAT) Total Score	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.	Baseline, Week 52
Secondary	Evaluate pharmacokinetics of tezepelumab	Serum trough concentration of tezepelumab	Weeks 0, 4, 12, 24, 36, 52, 64
Secondary	Evaluate immunogenicity of tezepelumab	Incidence of anti-drug antibodies (ADA)	Over 52 weeks