A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
NCT ID: NCT01402986
Last Updated: 2017-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
689 participants
INTERVENTIONAL
2011-08-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo, Q2W - Cohort 1
Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Placebo Q2W
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Tralokinumab 300 mg, Q2W - Cohort 1
Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Tralokinumab 300 mg, Q2W
Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.
Placebo, Q2/4W - Cohort 2
Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Placebo, Q2/4W
Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
Tralokinumab 300 mg, Q2/4W - Cohort 2
Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
Tralokinumab 300 mg, Q2/4W
Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
Interventions
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Placebo Q2W
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Tralokinumab 300 mg, Q2W
Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.
Placebo, Q2/4W
Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
Tralokinumab 300 mg, Q2/4W
Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 16-40 kilogram per square meter (kg/m\^2) at Visit 1
* Uncontrolled severe asthma
* A chest x-ray with no abnormality
* Females of childbearing potential who are sexually active with a non-sterilized male partner must use highly effective contraception from Day 1
* Non-sterilized males or sterilized males who are less than or equal to (=\<) 1 year post-vasectomy who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception
Exclusion Criteria
* Pregnant or breastfeeding women
* Any other respiratory disease
* Previously taken tralokinumab (the study drug)
* Current smoker or a history of smoking which would be more than 1 pack per day for 10 years
* Known immune deficiency
* History of cancer
* Hepatitis B, C or Human Immuno-deficiency Virus (HIV)
* Any disease which may cause complications whilst taking the study drug.
18 Years
75 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Piper, MBBS
Role: STUDY_DIRECTOR
Sponsor GmbH
Christopher Brightling
Role: PRINCIPAL_INVESTIGATOR
Institute for Lung Health
Locations
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Research Site
Rancho Mirage, California, United States
Research Site
Centennial, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Cocoa, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Albany, Georgia, United States
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Fargo, North Dakota, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Upland, Pennsylvania, United States
Research Site
Killeen, Texas, United States
Research Site
Buenos Aires, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
Research Site
Monte Grande, , Argentina
Research Site
Ranelagh, , Argentina
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Rosario, , Argentina
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Calgary, Alberta, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
Research Site
Quillota, , Chile
Research Site
Santiago, , Chile
Research Site
Valparaíso, , Chile
Research Site
Viña del Mar, , Chile
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Jindřichův Hradec, , Czechia
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Pilsen, , Czechia
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Rokycany, , Czechia
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Perpignan, , France
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Pessac, , France
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Strasbourg, , France
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Berlin, , Germany
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Frankfurt, , Germany
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Lübeck, , Germany
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Mainz, , Germany
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Chūōku, , Japan
Research Site
Fujisawa-shi, , Japan
Research Site
Fukuoka, , Japan
Research Site
Habikino-shi, , Japan
Research Site
Hiroshima, , Japan
Research Site
Itabashi-ku, , Japan
Research Site
Kagoshima, , Japan
Research Site
Kahoku-gun, , Japan
Research Site
Kishiwada-shi, , Japan
Research Site
Kobe, , Japan
Research Site
Kyoto, , Japan
Research Site
Maebashi, , Japan
Research Site
Morioka, , Japan
Research Site
Naka-gun, , Japan
Research Site
Sagamihara-shi, , Japan
Research Site
Sakaide-shi, , Japan
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Sapporo, , Japan
Research Site
Sumida-ku, , Japan
Research Site
Takatsuki-shi, , Japan
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Tomakomai-shi, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
Research Site
Culiacán, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
Research Site
Morelia, , Mexico
Research Site
Querétaro City, , Mexico
Research Site
Tampico, , Mexico
Research Site
Villahermosa, , Mexico
Research Site
Iloilo City, , Philippines
Research Site
Lipa City, , Philippines
Research Site
Quezon City, , Philippines
Research Site
Lodz, , Poland
Research Site
Wroclaw, , Poland
Research Site
Zabrze, , Poland
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Vladikavkaz, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Bucheon-si, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Pamplona, , Spain
Research Site
Sagunto(Valencia), , Spain
Research Site
Santander, , Spain
Research Site
Leicester, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
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References
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Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015 Sep;3(9):692-701. doi: 10.1016/S2213-2600(15)00197-6. Epub 2015 Jul 28.
Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.
Related Links
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CD-RI-CAT-354-1049 Redacted Protocol
Other Identifiers
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2011-001360-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CD-RI-CAT-354-1049
Identifier Type: -
Identifier Source: org_study_id
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