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. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2015-000857-19-GB |
Date of registration:
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13/05/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 2 study to evaluate the effect of Tralokinumab in adults with asthma inadequately controlled on inhaled corticosteroid.
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Scientific title:
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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 (MESOS) - MESOS |
Date of first enrolment:
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06/08/2015 |
Target sample size:
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80 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000857-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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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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Eva Augurell
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Address:
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85 Karlebyhus, Astraallén
SE-151 85
Sodertalje
Sweden |
Telephone:
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Email:
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information.centre@astrazeneca.com |
Affiliation:
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AstraZeneca AB |
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Name:
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Eva Augurell
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Address:
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85 Karlebyhus, Astraallén
SE-151 85
Sodertalje
Sweden |
Telephone:
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Email:
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information.centre@astrazeneca.com |
Affiliation:
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AstraZeneca AB |
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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 morning pre-bronchodilator (BD) FEV1>50% and more than 1L. 6. Post-BD reversibility in FEV1 of =12% and =200 mL at enrolment (v1). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 76 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
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:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Asthma
MedDRA version: 18.1
Level: PT
Classification code 10003553
Term: Asthma
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Product Name: Tralokinumab Product Code: CAT-354 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Tralokinumab CAS Number: 1044515-88-9 Current Sponsor code: CAT-354 Other descriptive name: Tralokinumab Concentration unit: mg/l milligram(s)/litre Concentration type: equal Concentration number: 150-150 Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To evaluate the effect of tralokinumab on blood eosinophil levels in adult subjects with asthma inadeuately controlled with ICS. To evaluate the effect of tralokinumab on activation of eosinophils in adult subjects with asthma inadequately controlled with ICS.
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Primary end point(s): The change, expressed as a ratio, in number of airway submucosal eosinophils per mm2 determined by microscopic evaluation of bronchoscopic biopsies from baseline up to week 12.
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Main Objective: To evaluate the effect of tralokinumab on eosinophilic airway infiltration in adult subjects with asthma inadequately controlled with ICS.
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Timepoint(s) of evaluation of this end point: Week 12
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Secondary Outcome(s)
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Secondary end point(s): 1. The change, expressed as a ratio, in number of blood eosinophils from baseline up to week 12. 2. The change, expressed as a ratio, in the number of differential sputum eosinophils from baseline up to week 12. 3. The change,expressed as a ratio, in blood and sputum free eosinophil cationic protein (ECP) concentrations from baseline up to week 12.
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Timepoint(s) of evaluation of this end point: 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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AstraZeneca AB
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Ethics review
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Status: Approved
Approval date:
Contact:
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