Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids

Asthma Clinical Trial

— MESOS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449473
• Other study ID #: D2210C00014
• Status: Completed
• Phase: Phase 2
• Start date: September 29, 2015
• Est. completion date: June 21, 2017

Study information

• Verified date: January 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a multicentre, randomized, double-blind, parallel group, placebo-controlled, phase 2 study to designed evaluate the effect of a 300 mg dose of tralokinumab administered subcutaneously every 2 weeks on airway inflammation in adults with asthma inadequately controlled on inhaled corticosteroids (ICS) with or without other controllers. Approximately 80 subjects will be randomized. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 12 week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 21, 2017
• Est. primary completion date: June 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Tralokinumab
Subcutaneous Injection

Other:
• Placebo
Subcutaneous Injection

Locations

Country	Name	City	State
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Vancouver	British Columbia
Denmark	Research Site	Ålborg
Denmark	Research Site	Århus C
Denmark	Research Site	Hvidovre
Denmark	Research Site	København NV
Denmark	Research Site	Odense C
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Denmark,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils	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.	Baseline (Week 0) and Week 12
Secondary	Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils	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.	Baseline (Week 0) and Week 12
Secondary	Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations	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.	Baseline (Week 0) and Week 12
Secondary	Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations	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.	Baseline (Week 0) and Week 12

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