Tezepelumab COPD Exacerbation Study

Last updated: February 17, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

2

Condition

Emphysema

Bronchiectasis

Chronic Obstructive Pulmonary Disease (Copd)

Treatment

Tezepelumab

Placebo

Clinical Study ID

NCT04039113
D5241C00001
2019-001363-67
  • Ages 40-80
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. History of moderate to very severe physician-diagnosed COPD for at least 12 monthsprior to enrolment with a post-bronchodilator FEV1/FVC<0.70 and apost-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 doseICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should bestable for 3 months prior to enrollment.

Exclusion

Exclusion Criteria:

  1. Clinically important pulmonary disease other than COPD, as judged by theInvestigator (including current or historic asthma diagnosis).

  2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal,hepatic, renal, neurological, musculoskeletal, infectious (including risk factorsfor pneumonia), endocrine, metabolic, hematological, psychiatric, or major physicalimpairment that is not stable.

  3. Major surgery within 8 weeks before enrollment.

  4. History of clinically significant infection requiring antibiotics or antiviralmedication within 14 days before enrollment.

  5. Pregnant or breastfeeding.

  6. The chest/lungs with pathology that precludes the patient's ability to complete thestudy

  7. The patient has active COVID 19 infection during screening period.

Study Design

Total Participants: 337
Treatment Group(s): 2
Primary Treatment: Tezepelumab
Phase: 2
Study Start date:
July 30, 2019
Estimated Completion Date:
January 31, 2024

Study 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.

Connect with a study center

  • Research Site

    Calgary, Alberta T2N 4Z6
    Canada

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  • Research Site

    Sherwood Park, Alberta T8L 0N2
    Canada

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    Vancouver, British Columbia V5Z 1M9
    Canada

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    Truro, Nova Scotia B2N 1L2
    Canada

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    Burlington, Ontario L7N 3V2
    Canada

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    Hamilton, Ontario L8N 3Z5
    Canada

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    Windsor, Ontario N8X-5A6
    Canada

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    Gatineau, Quebec J8Y 6S8
    Canada

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    Montreal, Quebec H1M 1B1
    Canada

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    Montréal, Quebec H1M 1B1
    Canada

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    St Charles Borromee, Quebec J6E 2B4
    Canada

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    Trois-Rivières, Quebec G8T 7A1
    Canada

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    Quebec, G1V 4G5
    Canada

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    Aarhus N, 8200
    Denmark

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    Hvidovre, 2650
    Denmark

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    København NV, 2400
    Denmark

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    Odense C, 5000
    Denmark

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    Roskilde, 4000
    Denmark

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    Vejle, 7100
    Denmark

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    Ålborg, 9000
    Denmark

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    Amiens Cedex 1, 80054
    France

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    Brest Cedex 2, 29609
    France

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    Creteil, 94010
    France

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    Grenoble Cedex, 38043
    France

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    Lyon Cedex 04, 69317
    France

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    Marseille, 13015
    France

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    Montpellier, 34090
    France

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    Nantes Cedex 1, 44093
    France

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    Berlin, 12203
    Germany

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    Frankfurt, 60596
    Germany

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    Grosshansdorf, 20927
    Germany

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    Lübeck, 23552
    Germany

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    Mainz, 55131
    Germany

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    Ashkelon, 7830604
    Israel

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    Beer Sheva, 84101
    Israel

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    Haifa, 34362
    Israel

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    Jerusalem, 91120
    Israel

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    Kfar Saba, 49281
    Israel

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    Rehovot, 7661041
    Israel

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    Daegu, 42415
    Korea, Republic of

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    Gyeonggi-do, 11765
    Korea, Republic of

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    Incheon, 21431
    Korea, Republic of

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    Jeonju-si, 54907
    Korea, Republic of

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    Seoul, 05030
    Korea, Republic of

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    Uijeongbu-si, 11765
    Korea, Republic of

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    Assen, 9401 RK
    Netherlands

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    Breda, 4818 CK
    Netherlands

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    Eindhoven, 5623 EJ
    Netherlands

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    Groningen, 9713 GZ
    Netherlands

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    Heerlen, 6419 PC
    Netherlands

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    Horn, 6085 NM
    Netherlands

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    Leeuwarden, 8934 AD
    Netherlands

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    Rotterdam, 3083 AN
    Netherlands

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    Zutphen, 7207 AE
    Netherlands

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    Alzira, 46410
    Spain

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    Barcelona, 08025
    Spain

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    Granada, 18014
    Spain

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    Málaga, 29010
    Spain

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    Mérida (Badajoz), 06800
    Spain

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    Birmingham, B15 2WB
    United Kingdom

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    Bradford, BND9 6RJ
    United Kingdom

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    Chertsey, KT16 0PZ
    United Kingdom

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    Cottingham, HU16 5JQ
    United Kingdom

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    Glasgow, G12 0YN
    United Kingdom

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    Larbert, FK5 4WR
    United Kingdom

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    London, SW10 9NH
    United Kingdom

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    Manchester, M23 9QZ
    United Kingdom

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    Newcastle-upon-Tyne, NE1 4LP
    United Kingdom

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    Northwood Middlesex, HA6 2RN
    United Kingdom

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    Oxford, OX3 7LE
    United Kingdom

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    Sidcup, DA14 6LT
    United Kingdom

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    Southampton, SO166YD
    United Kingdom

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    Wakefield, WF1 4DG
    United Kingdom

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    Wishaw, ML2 0DP
    United Kingdom

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    Wythenshawe, M23 9QZ
    United Kingdom

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    Anniston, Alabama 36207
    United States

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    Dothan, Alabama 36305
    United States

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    Phoenix, Arizona 85018
    United States

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    Huntington Beach, California 92647
    United States

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    Los Angeles, California 90095
    United States

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    Newport Beach, California 92663
    United States

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    Palm Springs, California 92262
    United States

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    Riverside, California 92506
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    Sacramento, California 95817
    United States

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    San Diego, California 92120
    United States

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    Upland, California 91786
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    Westminster, California 92683
    United States

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    Denver, Colorado 80206
    United States

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    New Haven, Connecticut 06510
    United States

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    Altamonte Springs, Florida 32701
    United States

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    Brandon, Florida 33511
    United States

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    Daytona Beach, Florida 32117
    United States

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    Fort Lauderdale, Florida 33308
    United States

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    Loxahatchee Groves, Florida 33470
    United States

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    Orlando, Florida 32819
    United States

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    Panama City, Florida 32405
    United States

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    Saint Petersburg, Florida 33707
    United States

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    Tampa, Florida 33607
    United States

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    Winter Park, Florida 32789-4681
    United States

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    Calhoun, Georgia 30701
    United States

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    Evanston, Illinois 60201
    United States

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    O'Fallon, Illinois 62269
    United States

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    Michigan City, Indiana 46360
    United States

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    Louisville, Kentucky 40202
    United States

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    Zachary, Louisiana 70791
    United States

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    Baltimore, Maryland 21224
    United States

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    Buckley, Michigan 49620
    United States

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    Edina, Minnesota 55435
    United States

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    Omaha, Nebraska 68198-5885
    United States

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    Albuquerque, New Mexico 87108
    United States

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    Buffalo, New York 14215
    United States

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    Charlotte, North Carolina 28277
    United States

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    Mooresville, North Carolina 28117
    United States

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    New Bern, North Carolina 28562
    United States

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    Cincinnati, Ohio 45231
    United States

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    Columbus, Ohio 43215
    United States

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  • Research Site

    Marion, Ohio 43302
    United States

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    Edmond, Oklahoma 73034
    United States

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    Medford, Oregon 97504
    United States

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    Philadelphia, Pennsylvania 19140
    United States

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    Pittsburgh, Pennsylvania 15213
    United States

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    Charleston, South Carolina 29407
    United States

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    Mount Pleasant, South Carolina 29464
    United States

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    Rock Hill, South Carolina 29732
    United States

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    Rapid City, South Dakota 57702
    United States

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    Boerne, Texas 78006
    United States

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    McKinney, Texas 75069
    United States

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  • Research Site

    Tomball, Texas 77375
    United States

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    Abingdon, Virginia 24210
    United States

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    Charlottesville, Virginia 22908
    United States

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  • Research Site

    Everett, Washington 98208
    United States

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  • Research Site

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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