A Phase 3 study to evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with asthma that is not controlled.
- Conditions
- AsthmaMedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-005615-27-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 837
1. Age 12 -75 years
2. Documented physician-diagnosed asthma at least 12 months prior to enrollment.
3. Documented treatment with ICS at a total daily dose corresponding to =500µg fluticasone
propionate dry powder formulation equivalents and a LABA for at least 3 months.
4. Morning pre-BD FEV1 value of =40 and <80% value (<90% for patients 12 to 17 years of
age) of their PNV
5. Post-BD reversibility of =12% and =200 mL in FEV1
6. ACQ-6 score =1.5
7. At least 2 documented asthma exacerbations in the 12 months prior to the date of informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 77
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 653
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Clinically important pulmonary 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method