Asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Tralokinumab
Product Code: CAT-354
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tralokinumab
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 12; 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. | — |
Countries
Canada, Denmark, United Kingdom
Contacts
Public ContactEva Augurell
AstraZeneca AB
Outcome results
None listed