Status:
COMPLETED
Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent Asthma.
Detailed Description
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 300 mg dose of tralokinumab administered subcutaneously every 2 wee...
Eligibility Criteria
Inclusion
- 1\) Age 12-75 2) Documented physician-diagnosed asthma. 3) Documented treatment with ICS at a total daily dose corresponding to ≥500µg fluticasone propionate dry powder formulation and a LABA. 4) Subjects must have received OCS for the treatment of asthma for 6 months prior to Visit 1 and on a stable OCS dose between ≥7.5 to ≤30mg daily or daily equivalent for at least one month prior to enrolment (Visit 1) . 5) Pre-BD FEV1 value \<80% (\<90% for patients 12-17 yrs of age) of their PNV. 6) Post-BD reversibility of ≥12% in FEV1.
Exclusion
- 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.
Key Trial Info
Start Date :
February 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2017
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT02281357
Start Date
February 19 2015
End Date
September 7 2017
Last Update
March 15 2019
Active Locations (51)
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1
Research Site
New Haven, Connecticut, United States, 06520
2
Research Site
Clearwater, Florida, United States, 33765
3
Research Site
St Louis, Missouri, United States, 63141
4
Research Site
Rochester, New York, United States, 14618