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NCT03406078 | Completed | Asthma

Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Sponsor:

AstraZeneca

Brief Summary:

Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Condition or disease

Asthma

Intervention/treatment

Tezepelumab

Placebo

Phase

Phase 3

Detailed Description:

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Study Type : Interventional
Estimated Enrollment : 150 participants
Masking: Triple
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE)
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : September 25, 2020
Arm Intervention/treatment

Experimental: Tezepelumab

Tezepelumab subcutaneous injection

Biological: Tezepelumab

Placebo Comparator: Placebo

Placebo subcutaneous injection

Other: Placebo
Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Subjects must have received a physician-prescribed medium- or high-dose ICS as per GINA guideline for at least 12 months
  • Subjects must have received physician prescribed LABA and high dose ICS (total daily dose >500μg fluticasone propionate dry powder formulation equivalent) for at least 3 months. The ICS and LABA can be parts of a combination product, or given by separate inhalers.
  • Additional maintenance asthma controller medications are allowed according to standard practice of care i.e., leukotriene receptor antagonists (LTRAs), theophylline, long-acting muscarinic antagonists (LAMAs), secondary ICS and cromones. The use of these medications must be documented for at least 3 months
  • Subjects must have received OCS for the treatment of asthma for at least 6 months prior to screening and on a stable dose of between ≥ 7.5 to ≤ 30mg (prednisone or prednisolone equivalent) daily or daily equivalent for at least 1 month. The OCS dose may be administered every other day (or different doses every other day); Average dose over two days = The daily dose.
  • Morning pre-bronchodilator (BD) FEV1 must be < 80% predicted normal
  • Subjects must have evidence of asthma as documented by post-BD (albuterol/salbutatomol) reversibility of FEV1 ≥12% and ≥200 mL (15-30 min after administration of 4 puffs of albuterol/salbutamol), documented either in the previous 12 months
  • Subjects must have a history of at least 1 asthma exacerbation event within 12 months
  • Minimum 10 days compliance with the morning and evening eDiary completion and OCS,ICS,LABA as well as other asthma controller medications as captured in the eDiary during the 14 days prior to randomization
  • Documented physician-diagnosed asthma for at least 12 months
Exclusion Criteria
  • Any clinically important pulmonary disease other than asthma (e.g. active lung infection, Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
  • 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 in the opinion of the Investigator and could
    • Affect the safety of the subject throughout the study Influence the findings of the study or the interpretation Impede the subject's ability to complete the entire duration of study
    • History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to visit 1.Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years
    • A helminth parasitic infection diagnosed within 6 months prior to screening that has not been treated with, or has failed to respond to, standard of care therapy.
    • Current smokers or subjects with smoking history ≥ 10 pack-years and subjects using vaping products, including electronic cigarettes. Former smokers with a smoking history of <10 pack years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to visit 1 to be eligible.
    • History of chronic alcohol or drug abuse within 12 months
    • Tuberculosis requiring treatment within the 12 months
    • History of any known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
    • Major surgery within 8 weeks prior to visit 1 or planned surgical procedures requiring general anaesthesia or in-subject status for >1 day during the conduct of the study.
    • Clinically significant asthma exacerbation, in the opinion of the Investigator, including those requiring use of systemic corticosteroids or increase in the maintenance dose of OCS within 30 days
Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

Location Details

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Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Research Site

Bakersfield, California, United States, 93301

Not yet recruiting

United States, Delaware

Research Site

Newark, Delaware, United States, 19713

Not yet recruiting

United States, Florida

Research Site

Kissimmee, Florida, United States, 34741

Not yet recruiting

United States, Florida

Research Site

Kissimmee, Florida, United States, 34746

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United States, Massachusetts

Research Site

Fall River, Massachusetts, United States, 02721

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United States, Michigan

Research Site

Ann Arbor, Michigan, United States, 48109

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United States, Missouri

Research Site

Saint Louis, Missouri, United States, 63141

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United States, New York

Research Site

Bronx, New York, United States, 10461

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United States, North Carolina

Research Site

Durham, North Carolina, United States, 27705

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United States, North Carolina

Research Site

Greenville, North Carolina, United States, 27834

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United States, Ohio

Research Site

Cincinnati, Ohio, United States, 45231

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United States, Ohio

Research Site

Cleveland, Ohio, United States, 44130

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United States, Ohio

Research Site

Toledo, Ohio, United States, 43617

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United States, Oklahoma

Research Site

Oklahoma City, Oklahoma, United States, 73109

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United States, Pennsylvania

Research Site

Altoona, Pennsylvania, United States, 16602

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United States, Pennsylvania

Research Site

Homestead, Pennsylvania, United States, 15120

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United States, Pennsylvania

Research Site

Philadelphia, Pennsylvania, United States, 19140

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United States, South Carolina

Research Site

Anderson, South Carolina, United States, 29621

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United States, South Carolina

Research Site

North Charleston, South Carolina, United States, 29406

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United States, Texas

Research Site

McKinney, Texas, United States, 75069

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United States, Texas

Research Site

San Antonio, Texas, United States, 78251

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Argentina,

Research Site

Buenos Aires, Argentina, C1414AIF

Not yet recruiting

Argentina,

Research Site

Ciudad de Buenos Aire, Argentina, C1425BEN

Not yet recruiting

Argentina,

Research Site

Córdoba, Argentina, X5003DCE

Not yet recruiting

Argentina,

Research Site

Mendoza, Argentina, 5500

Not yet recruiting

Argentina,

Research Site

Quilmes, Argentina, B1878FNR

Not yet recruiting

Argentina,

Research Site

San Fernando, Argentina, 1646

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Argentina,

Research Site

San Miguel de Tucuman, Argentina, T4000IAR

Not yet recruiting

Germany,

Research Site

Aschaffenburg, Germany, 63739

Not yet recruiting

Germany,

Research Site

Bamberg, Germany, 96049

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Germany,

Research Site

Berlin, Germany, 10367

Not yet recruiting

Germany,

Research Site

Berlin, Germany, 10717

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Germany,

Research Site

Berlin, Germany, 10969

Not yet recruiting

Germany,

Research Site

Hamburg, Germany, 22299

Not yet recruiting

Germany,

Research Site

Hannover, Germany, 30625

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Germany,

Research Site

Hannover, Germany, D-30173

Not yet recruiting

Germany,

Research Site

Koblenz, Germany, 56068

Not yet recruiting

Germany,

Research Site

Lübeck, Germany, 23552

Not yet recruiting

Germany,

Research Site

Mainz Am Rhein, Germany, 55131

Not yet recruiting

Germany,

Research Site

München, Germany, 81377

Not yet recruiting

Korea, Republic of,

Research Site

Daegu, Korea, Republic of, 42415

Not yet recruiting

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03082

Not yet recruiting

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03312

Not yet recruiting

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 03722

Not yet recruiting

Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 05505

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Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 06351

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Korea, Republic of,

Research Site

Seoul, Korea, Republic of, 06591

Not yet recruiting

Poland,

Research Site

Kraków, Poland, 31-559

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Poland,

Research Site

Wrocław, Poland, 53-301

Not yet recruiting

Poland,

Research Site

Łódź, Poland, 90-153

Not yet recruiting

Turkey,

Research Site

Adana, Turkey, 01330

Not yet recruiting

Turkey,

Research Site

Ankara, Turkey, 06230

Not yet recruiting

Turkey,

Research Site

Ankara, Turkey, 06280

Not yet recruiting

Turkey,

Research Site

Bursa, Turkey, 16059

Not yet recruiting

Turkey,

Research Site

Istanbul, Turkey, 34098

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Turkey,

Research Site

Manisa, Turkey, 45030

Not yet recruiting

Ukraine,

Research Site

Dnipro, Ukraine, 49007

Not yet recruiting

Ukraine,

Research Site

Kherson, Ukraine, 73000

Not yet recruiting

Ukraine,

Research Site

Lutsk, Ukraine, 4300

Not yet recruiting

Ukraine,

Research Site

Vinnytsia, Ukraine, 21029