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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02449473 |
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Date of registration:
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18/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids
MESOS |
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Scientific title:
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A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Ph 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults With Asthma Inadequately Controlled on Inhaled Corticosteroid (MESOS) |
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Date of first enrolment:
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September 29, 2015 |
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Target sample size:
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79 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02449473 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Denmark
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United Kingdom
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Contacts
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Name:
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Christopher Brightling, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute for Lung Health, United Kingdom |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age 18 to 75 years
2. Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
3. Documented treatment with an asthma controller regimen requiring treatment with ICS
(minimum dose of = 250 ug fluticasone propionate via dry powder inhaler equivalents
total daily dose) alone or in combination = 6 months and that has been taken at a
stable dose for at least 1 month prior to enrolment (v1)
4. Additional maintenance asthma controller medications must be given at a stable dose
for at least 1 month prior to v1.
5. At enrolment (v1) the subject must have a predicted normal value (PNV) for the
pre-bronchodilator (BD) FEV1>50% and more than 1L.
6. Post-BD reversibility in FEV1 of =12% and =200 mL at enrolment (v1).
Exclusion Criteria:
1. History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or
other clinically significant lung disease other than asthma.
2. History of anaphylaxis following any biologic therapy.
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for >10 pack-years.
7. Previous receipt of tralokinumab
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Biological: Tralokinumab
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Other: Placebo
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Primary Outcome(s)
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Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils
[Time Frame: Baseline (Week 0) and Week 12]
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Secondary Outcome(s)
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Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations
[Time Frame: Baseline (Week 0) and Week 12]
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Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils
[Time Frame: Baseline (Week 0) and Week 12]
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Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils
[Time Frame: Baseline (Week 0) and Week 12]
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Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations
[Time Frame: Baseline (Week 0) and Week 12]
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Secondary ID(s)
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D2210C00014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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