Status:
COMPLETED
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Uncontrolled Asthma
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequate...
Detailed Description
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma o...
Eligibility Criteria
Inclusion
- Age 12 -75
- Documented physician-diagnosed asthma.
- Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
- Morning pre-BD FEV1 value of ≥40 and \<80% value (\<90% for patients 12 to 17 years of age) of their PNV.
- Post-BD reversibility of ≥12% and ≥200 mL in FEV1
- ACQ-6 score ≥1.5
Exclusion
- Pulmonary disease other than asthma
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant or breastfeeding
- History of cancer
- Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
- Previous receipt of tralokinumab
Key Trial Info
Start Date :
October 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2017
Estimated Enrollment :
856 Patients enrolled
Trial Details
Trial ID
NCT02194699
Start Date
October 30 2014
End Date
September 21 2017
Last Update
May 15 2018
Active Locations (234)
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1
Research Site
Birmingham, Alabama, United States, 35294
2
Research Site
Hoover, Alabama, United States, 35244
3
Research Site
Huntsville, Alabama, United States, 35803
4
Research Site
Scottsdale, Arizona, United States, 85251