A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
STRATOS1
1 other identifier
interventional
1,207
15 countries
243
Brief Summary
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2014
Typical duration for phase_3
243 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedStudy Start
First participant enrolled
June 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2017
CompletedResults Posted
Study results publicly available
April 17, 2018
CompletedAugust 28, 2018
July 1, 2018
2.7 years
June 5, 2014
December 21, 2017
July 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualised Asthma Exacerbation Rate (AAER) up to Week 52
Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.
Baseline (Week 0) up to Week 52
Secondary Outcomes (17)
Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)
Baseline (Week 0) and Week 52
Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)
Baseline (Week 0) and Week 52
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score
Baseline (Week 0) and Week 52
Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score
Baseline (Week 0) and Week 52
AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52
Baseline (Week 0) up to Week 52
- +12 more secondary outcomes
Study Arms (4)
Tralokinumab Dose Regimen 1
EXPERIMENTALTralokinumab subcutaneous injection
Placebo Dose Regimen 1
PLACEBO COMPARATORPlacebo subcutaneous injection
Tralokinumab Dose Regimen 2
EXPERIMENTALTralokinumab subcutaneous injection
Placebo Dose Regimen 2
PLACEBO COMPARATORPlacebo subcutaneous injection
Interventions
Eligibility Criteria
You may qualify if:
- Age 12 -75
- Documented physician-diagnosed asthma.
- Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
- Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12 to 17 years of age) of their PNV.
- Post-BD reversibility of ≥12% and ≥200 mL in FEV1
- ACQ-6 score ≥1.5
You may not qualify if:
- Pulmonary disease other than asthma
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant or breastfeeding
- History of cancer
- Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
- Previous receipt of tralokinumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (243)
Research Site
Birmingham, Alabama, 35209, United States
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Phoenix, Arizona, 85018, United States
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Arcadia, California, 91007, United States
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Los Angeles, California, 90036, United States
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Los Angeles, California, 90048, United States
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Newport Beach, California, 92663, United States
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Poway, California, 92064, United States
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San Jose, California, 95117, United States
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Tustin, California, 92780, United States
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Wildomar, California, 92595, United States
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Colorado Springs, Colorado, 80907, United States
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Denver, Colorado, 80206, United States
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Denver, Colorado, 80246, United States
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New Haven, Connecticut, 06519, United States
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Clearwater, Florida, 33765, United States
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Coral Gables, Florida, 33134, United States
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Cutler Bay, Florida, 33189, United States
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Fort Lauderdale, Florida, 33308, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33013, United States
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Homestead, Florida, 33030, United States
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Homestead, Florida, 33130, United States
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Jacksonville, Florida, 32277, United States
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Kissimmee, Florida, 34741, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33134, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33145, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33166, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33174, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33176, United States
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Ormond Beach, Florida, 32174, United States
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Pembroke Pines, Florida, 33029, United States
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Winter Park, Florida, 32789, United States
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Albany, Georgia, 31707, United States
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Atlanta, Georgia, 30331, United States
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Lawrenceville, Georgia, 30046, United States
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Meridian, Idaho, 83642, United States
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Twin Falls, Idaho, 83301, United States
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Fort Wayne, Indiana, 46804, United States
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South Bend, Indiana, 46617, United States
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Bowling Green, Kentucky, 42101, United States
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Bangor, Maine, 04401, United States
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Brockton, Massachusetts, 2301, United States
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Ann Arbor, Michigan, 48106, United States
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Farmington Hills, Michigan, 48334, United States
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Flint, Michigan, 48504, United States
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Ypsilanti, Michigan, 48197, United States
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Chesterfield, Missouri, 63017, United States
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St Louis, Missouri, 63141, United States
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St Louis, Missouri, 63143, United States
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Missoula, Montana, 59808, United States
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Las Vegas, Nevada, 89123, United States
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Union, New Jersey, 07083, United States
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Brooklyn, New York, 11229, United States
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Asheville, North Carolina, 28801, United States
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Charlotte, North Carolina, 28277, United States
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Cornelius, North Carolina, 28031, United States
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Hickory, North Carolina, 28078, United States
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Shelby, North Carolina, 28150, United States
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Winston-Salem, North Carolina, 27104, United States
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Columbus, Ohio, 43235, United States
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Middleburg Heights, Ohio, 44130, United States
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Toledo, Ohio, 43617, United States
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Oklahoma City, Oklahoma, 73112, United States
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Oklahoma City, Oklahoma, 73131, United States
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Monroeville, Pennsylvania, 15146, United States
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Philadelphia, Pennsylvania, 19115, United States
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Scottdale, Pennsylvania, 15683, United States
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Uniontown, Pennsylvania, 15683, United States
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Johnston, Rhode Island, 02919, United States
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Providence, Rhode Island, 02908, United States
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Warwick, Rhode Island, 02886, United States
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Anderson, South Carolina, 29621, United States
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Greenville, South Carolina, 29607, United States
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Myrtle Beach, South Carolina, 29588, United States
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Spartanburg, South Carolina, 29303, United States
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Boerne, Texas, 78006, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75225, United States
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Fort Worth, Texas, 76104, United States
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Fort Worth, Texas, 76109, United States
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Houston, Texas, 77043, United States
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Houston, Texas, 77084, United States
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Houston, Texas, 77099, United States
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Lampasas, Texas, 76550, United States
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McKinney, Texas, 75069, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78218, United States
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San Antonio, Texas, 78258, United States
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Murray, Utah, 84107, United States
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Provo, Utah, 84604, United States
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Salt Lake City, Utah, 84102, United States
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South Burlington, Vermont, 05403, United States
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Arlington, Virginia, 22203, United States
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Richmond, Virginia, 23225, United States
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Richland, Washington, 99352, United States
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Tacoma, Washington, 98405, United States
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Buenos Aires, C1414AIF, Argentina
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CABA, C1425BEN, Argentina
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Cap. Fed, 1280, Argentina
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Ciudad Autonomade Buenos Aires, 1426, Argentina
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Concepción del Uruguay, 3260, Argentina
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Córdoba, X5003DCE, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500GIP, Argentina
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Quilmes, B1878FNR, Argentina
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Rosario, S2000DEJ, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Brussels (Anderlecht), 1070, Belgium
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Erpent, 5101, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Dupnitsa, 2600, Bulgaria
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Kozloduy, 3320, Bulgaria
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Pazardzhik, 4400, Bulgaria
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Pernik, 2307, Bulgaria
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Rousse, 7002, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1618, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Varna, 9000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vratsa, 3000, Bulgaria
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Yambol, 8600, Bulgaria
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Armenia, 630004, Colombia
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Bogotá, 110311, Colombia
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Bogotá, Colombia
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Cali, 76001000, Colombia
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Aschaffenburg, 63739, Germany
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Augsburg, 86150, Germany
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Bad Lippspringe, 33175, Germany
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Geesthacht, 21502, Germany
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Herford, 32049, Germany
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Landsberg, 86899, Germany
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Leipzig, 04357, Germany
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München-Pasing, 81241, Germany
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Reinfeld, 23858, Germany
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Rodgau-Dudenhofen, 63110, Germany
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Warendorf, 48231, Germany
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Balassagyarmat, 2660, Hungary
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Edelény, 3780, Hungary
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Farkasgyepü, 8582, Hungary
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Komárom, 2900, Hungary
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Létavértes, 4281, Hungary
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Miskolc, 3529, Hungary
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Pécs, 7626, Hungary
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Pécs, 7635, Hungary
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Százhalombatta, 2440, Hungary
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Cusco, CUSCO 01, Peru
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Lima, 41, Peru
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Lima, L27, Peru
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Lima, LIMA 1, Peru
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Lima, LIMA 21, Peru
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Lima, LIMA 29, Peru
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Lima, LIMA 32, Peru
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Lima, LIMA 33, Peru
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Lima, LIMA 41, Peru
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Będzin, 42-500, Poland
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Bydgoszcz, 85-079, Poland
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Chorzów, 41-500, Poland
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Gdansk, 80-405, Poland
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Gdansk, 80-546, Poland
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Grudziądz, 86-300, Poland
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Kielce, 25-734, Poland
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Krakow, 31-209, Poland
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Lodz, 90-153, Poland
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Lubin, 59-300, Poland
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Lublin, 20-363, Poland
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Lublin, 20-468, Poland
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Mrozy, 05-320, Poland
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Olsztyn, 10-357, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Oświęcim, 32-600, Poland
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Puławy, 24-100, Poland
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Racibórz, 47-400, Poland
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Skierniewice, 96-100, Poland
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Staszów, 28-200, Poland
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Warsaw, 01-138, Poland
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Wieluń, 98-300, Poland
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Wołomin, 05-200, Poland
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Wroclaw, 50-220, Poland
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Wroclaw, 51-162, Poland
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Zamość, 22-400, Poland
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Zgierz, 95-100, Poland
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Humenné, 066 01, Slovakia
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Kežmarok, 060 01, Slovakia
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Prešov, 08001, Slovakia
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Sabinov, Slovakia
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Topoľčany, 955 01, Slovakia
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Bucheon-si, 14584, South Korea
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Cheongju-si, 362-804, South Korea
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Daegu, 42415, South Korea
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Incheon, 21431, South Korea
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Incheon, 405-760, South Korea
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Jeju City, 63241, South Korea
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Seoul, 02559, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 08308, South Korea
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Seoul, 135-710, South Korea
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Seoul, 150-713, South Korea
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Suwon, 16499, South Korea
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Alicante, 03004, Spain
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Badalona, 08916, Spain
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Hospitalet de Llobregat(Barcel, 08907, Spain
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Santander, 39008, Spain
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Valencia, 46015, Spain
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Changhua, 500, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, 22056, Taiwan
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Taichung, 404, Taiwan
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Taipei, 100, Taiwan
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Taipei, 235, Taiwan
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Yilan, 260, Taiwan
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Chernivtsi, 58000, Ukraine
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Chernivtsi, 58001, Ukraine
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Ivano-Frankivsk, 76012, Ukraine
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Kharkiv, 61002, Ukraine
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Kharkiv, 61058, Ukraine
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Kharkiv, 61093, Ukraine
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Kyiv, 02125, Ukraine
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Lutsk, 43000, Ukraine
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Lviv, 79066, Ukraine
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Odesa, 65025, Ukraine
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Vinnytsia, 21001, Ukraine
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Zaporizhzhya, 69063, Ukraine
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Zaporizhzhya, 69065, Ukraine
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh, Vietnam
Related Publications (4)
Gottlow M, Svensson DJ, Lipkovich I, Huhn M, Bowen K, Wessman P, Colice G. Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma. BMC Pulm Med. 2019 Jul 17;19(1):129. doi: 10.1186/s12890-019-0889-4.
PMID: 31315668DERIVEDCarlsson M, Braddock M, Li Y, Wang J, Xu W, White N, Megally A, Hunter G, Colice G. Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma. Drug Saf. 2019 Jun;42(6):769-784. doi: 10.1007/s40264-018-00788-w.
PMID: 30649752DERIVEDPanettieri RA Jr, Sjobring U, Peterffy A, Wessman P, Bowen K, Piper E, Colice G, Brightling CE. Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials. Lancet Respir Med. 2018 Jul;6(7):511-525. doi: 10.1016/S2213-2600(18)30184-X. Epub 2018 May 20.
PMID: 29792288DERIVEDPanettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.
PMID: 29536781DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Reynold A Panettieri, M.D.
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2014
First Posted
June 12, 2014
Study Start
June 13, 2014
Primary Completion
February 28, 2017
Study Completion
July 18, 2017
Last Updated
August 28, 2018
Results First Posted
April 17, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share
This is commercially sensitive information.