A Safety and Efficacy Study of Tralokinumab in Adults With Asthma
A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma
2 other identifiers
interventional
689
15 countries
89
Brief Summary
The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Aug 2011
Typical duration for phase_2 asthma
89 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
July 21, 2011
CompletedFirst Posted
Study publicly available on registry
July 27, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedResults Posted
Study results publicly available
March 6, 2017
CompletedApril 4, 2017
March 1, 2017
1.8 years
July 21, 2011
May 31, 2016
March 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual Asthma Exacerbation Rate (AER)
Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids (OCS) is administered (10 days after administration of an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.
Week 1 up to Week 53
Secondary Outcomes (42)
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53
Baseline and Week 53
Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53
Baseline and Week 53
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53
Baseline and Week 53
Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53
Baseline and Week 53
Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53
Baseline and Week 53
- +37 more secondary outcomes
Study Arms (4)
Placebo, Q2W - Cohort 1
PLACEBO COMPARATORParticipants 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
EXPERIMENTALParticipants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Placebo, Q2/4W - Cohort 2
PLACEBO COMPARATORParticipants 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.
Tralokinumab 300 mg, Q2/4W - Cohort 2
EXPERIMENTALParticipants 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.
Interventions
Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.
Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
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.
Eligibility Criteria
You may qualify if:
- Age 18-75 years
- 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
You may not qualify if:
- Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (89)
Research Site
Rancho Mirage, California, United States
Research Site
Centennial, Colorado, United States
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New Haven, Connecticut, United States
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Cocoa, Florida, United States
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Miami, Florida, United States
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Winter Park, Florida, United States
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Albany, Georgia, United States
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Fargo, North Dakota, United States
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Philadelphia, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Killeen, Texas, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Monte Grande, Argentina
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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
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Quillota, Chile
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Santiago, Chile
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Valparaíso, Chile
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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
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Fujisawa-shi, Japan
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Fukuoka, Japan
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Habikino-shi, Japan
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Hiroshima, Japan
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Itabashi-ku, Japan
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Kagoshima, Japan
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Kahoku-gun, Japan
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Kishiwada-shi, Japan
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Kobe, Japan
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Kyoto, Japan
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Maebashi, Japan
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Morioka, Japan
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Naka-gun, Japan
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Sagamihara-shi, Japan
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Sakaide-shi, Japan
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Sapporo, Japan
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Sumida-ku, Japan
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Takatsuki-shi, Japan
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Tomakomai-shi, Japan
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Wakayama, Japan
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Yokohama, Japan
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Culiacán, Mexico
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Guadalajara, Mexico
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México, Mexico
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Morelia, Mexico
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Querétaro City, Mexico
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Tampico, Mexico
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Villahermosa, Mexico
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Iloilo City, Philippines
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Lipa City, Philippines
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Quezon City, Philippines
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Lodz, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Moscow, Russia
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Novosibirsk, Russia
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Saint Petersburg, Russia
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Vladikavkaz, Russia
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Yekaterinburg, Russia
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Bucheon-si, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Barcelona, Spain
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Madrid, Spain
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Pamplona, Spain
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Sagunto(Valencia), Spain
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Santander, Spain
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Leicester, United Kingdom
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Manchester, United Kingdom
Related Publications (2)
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.
PMID: 26231288BACKGROUNDBaverel 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.
PMID: 28758192DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Meena Jain, MB BChir, Director, Clinical Development,
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
Edward Piper, MBBS
Sponsor GmbH
- PRINCIPAL INVESTIGATOR
Christopher Brightling
Institute for Lung Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2011
First Posted
July 27, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2013
Study Completion
February 1, 2014
Last Updated
April 4, 2017
Results First Posted
March 6, 2017
Record last verified: 2017-03