Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids
MESOS
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)
1 other identifier
interventional
79
3 countries
15
Brief Summary
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Sep 2015
Typical duration for phase_2 asthma
15 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
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedStudy Start
First participant enrolled
September 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2017
CompletedResults Posted
Study results publicly available
January 8, 2019
CompletedJanuary 8, 2019
January 1, 2019
1.7 years
May 18, 2015
May 23, 2018
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils
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.
Baseline (Week 0) and Week 12
Secondary Outcomes (4)
Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils
Baseline (Week 0) and Week 12
Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils
Baseline (Week 0) and Week 12
Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations
Baseline (Week 0) and Week 12
Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations
Baseline (Week 0) and Week 12
Study Arms (2)
Tralokinumab Dose Regimen
EXPERIMENTALTralokinumab Subcutaneous Injection
Placebo Dose Regimen
PLACEBO COMPARATORPlacebo Subcutaneous Injection
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Vancouver, British Columbia, V5Z 1M9, Canada
Research Site
Montreal, Quebec, H4A 3J1, Canada
Research Site
Québec, Quebec, G1V 4G5, Canada
Research Site
Aalborg, 9000, Denmark
Research Site
Århus C, 8000, Denmark
Research Site
Hvidovre, 2650, Denmark
Research Site
København NV, 2400, Denmark
Research Site
Odense C, 5000, Denmark
Research Site
Belfast, BT12 6BA, United Kingdom
Research Site
Glasgow, G12 OYN, United Kingdom
Research Site
Leicester, LE3 9QP, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, M23 9QZ, United Kingdom
Research Site
Nottingham, NG5 1PB, United Kingdom
Research Site
Southampton, SO16 6YD, United Kingdom
Related Publications (3)
Diver S, Sridhar S, Khalfaoui LC, Russell RJ, Emson C, Griffiths JM, de Los Reyes M, Yin D, Colice G, Brightling CE. Feno differentiates epithelial gene expression clusters: Exploratory analysis from the MESOS randomized controlled trial. J Allergy Clin Immunol. 2022 Oct;150(4):830-840. doi: 10.1016/j.jaci.2022.04.024. Epub 2022 May 7.
PMID: 35537502DERIVEDRussell RJ, Chachi L, FitzGerald JM, Backer V, Olivenstein R, Titlestad IL, Ulrik CS, Harrison T, Singh D, Chaudhuri R, Leaker B, McGarvey L, Siddiqui S, Wang M, Braddock M, Nordenmark LH, Cohen D, Parikh H, Colice G, Brightling CE; MESOS study investigators. Effect of tralokinumab, an interleukin-13 neutralising monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomised, placebo-controlled phase 2 trial. Lancet Respir Med. 2018 Jul;6(7):499-510. doi: 10.1016/S2213-2600(18)30201-7. Epub 2018 May 21.
PMID: 29793857DERIVEDPanettieri 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The results for differential sputum eosinophils and sputum free ECP levels should be viewed cautiously due to the small sample size and wide variability in results for sputum analyses.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Brightling, MD
Institute for Lung Health, United Kingdom
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
May 18, 2015
First Posted
May 20, 2015
Study Start
September 29, 2015
Primary Completion
June 21, 2017
Study Completion
June 21, 2017
Last Updated
January 8, 2019
Results First Posted
January 8, 2019
Record last verified: 2019-01