Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids (MESOS)
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ClinicalTrials.gov Identifier: NCT02449473 |
Recruitment Status :
Completed
First Posted : May 20, 2015
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Biological: Tralokinumab Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | September 29, 2015 |
Actual Primary Completion Date : | June 21, 2017 |
Actual Study Completion Date : | June 21, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Tralokinumab Dose Regimen
Tralokinumab Subcutaneous Injection
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Biological: Tralokinumab
Subcutaneous Injection |
Placebo Comparator: Placebo Dose Regimen
Placebo Subcutaneous Injection
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Other: Placebo
Subcutaneous Injection |
- Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils [ Time Frame: Baseline (Week 0) and Week 12 ]The number of airway submucosal eosinophils per millimetre squared (mm^2) was determined by microscopic evaluation of bronchoscopic biopsies. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of airway submucosal eosinophils is presented as geometric mean ± standard deviation (SD) of log values.
- Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils [ Time Frame: Baseline (Week 0) and Week 12 ]The blood eosinophil count was obtained from the total and differential white blood cell counts. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of blood eosinophils is presented as geometric mean ± SD of log values.
- Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils [ Time Frame: Baseline (Week 0) and Week 12 ]Sputum induction was performed to obtain satisfactory samples of sputum originating from the airways. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of eosinophils in induced sputum is presented as geometric mean ± SD of log values.
- 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 ]ECP concentrations were determined to assess evidence of activation of eosinophils in blood. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in blood free ECP concentrations is presented as geometric mean ± SD of log values.
- Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations [ Time Frame: Baseline (Week 0) and Week 12 ]ECP concentrations were determined to assess evidence of activation of eosinophils in sputum. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in sputum free ECP concentrations is presented as geometric mean ± SD of log values.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 to 75 years
- Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
- 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)
- Additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
- At enrolment (v1) the subject must have a predicted normal value (PNV) for the pre-bronchodilator (BD) FEV1>50% and more than 1L.
- Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).
Exclusion Criteria:
- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449473
Canada, British Columbia | |
Research Site | |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Canada, Quebec | |
Research Site | |
Montreal, Quebec, Canada, H4A 3J1 | |
Canada | |
Research Site | |
Quebec, Canada, G1V 4G5 | |
Denmark | |
Research Site | |
Hvidovre, Denmark, 2650 | |
Research Site | |
København NV, Denmark, 2400 | |
Research Site | |
Odense C, Denmark, 5000 | |
Research Site | |
Ålborg, Denmark, 9000 | |
Research Site | |
Århus C, Denmark, 8000 | |
United Kingdom | |
Research Site | |
Belfast, United Kingdom, BT12 6BA | |
Research Site | |
Glasgow, United Kingdom, G12 OYN | |
Research Site | |
Leicester, United Kingdom, LE3 9QP | |
Research Site | |
London, United Kingdom | |
Research Site | |
Manchester, United Kingdom, M23 9QZ | |
Research Site | |
Nottingham, United Kingdom, NG5 1PB | |
Research Site | |
Southampton, United Kingdom, SO16 6YD |
Principal Investigator: | Christopher Brightling, MD | Institute for Lung Health, United Kingdom |
Documents provided by AstraZeneca:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT02449473 |
Other Study ID Numbers: |
D2210C00014 |
First Posted: | May 20, 2015 Key Record Dates |
Results First Posted: | January 8, 2019 |
Last Update Posted: | January 8, 2019 |
Last Verified: | January 2019 |
Asthma Reactive Airways Respiratory Tract Disease Obstructive Tract Disease Lung Diseases |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |