A Phase 2 study to evaluate the effect of Tralokinumab in adults with asthma inadequately controlled on inhaled corticosteroid.

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2015-000857-19-DK
• Date of registration: 12/10/2015
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A Phase 2 study to evaluate the effect of Tralokinumab in adults with asthma inadequately controlled on inhaled corticosteroid.
• Scientific title: 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: 20/11/2015
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000857-19
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Denmark, United Kingdom

Contacts

• Name: Eva Augurell
• Affiliation: AstraZeneca AB

• Name: Eva Augurell
• Affiliation: AstraZeneca AB

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

Main Objective: To evaluate the effect of tralokinumab on eosinophilic airway infiltration in adult subjects with asthma inadequately controlled with ICS.

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.

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

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 eosinophil cationic protein (ECP) concentrations from baseline up to week 12.

Timepoint(s) of evaluation of this end point: Week 12

Secondary ID(s)

2015-000857-19-GB

D2210C00014

Source(s) of Monetary Support

AstraZeneca AB