Phase 3 Study to Evaluate the Efficacy & Safety of Tralokinumab in Adults & Adolescents With OCS Dependent Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02281357

Run by

AstraZeneca

People needed

140

Starts

2015-02-19

Expected to finish

2017-09-07

Last updated by the study team

2019-03-15

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Clearwater, Florida, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Rochester, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Monroeville, Pennsylvania, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Anderson, South Carolina, United States
• Research Site — Spartanburg, South Carolina, United States
• Research Site — Boerne, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Tyler, Texas, United States
• Research Site — Richmond, Virginia, United States
• Research Site — Brussels (Anderlecht), Belgium
• Research Site — Ghent, Belgium
• Research Site — Hasselt, Belgium
• Research Site — Leuven, Belgium
• Research Site — Woluwé-St-Lambert, Belgium
• Research Site — Grenoble, France
• Research Site — Lille, France
• Research Site — Lyon, France
• Research Site — Nantes, France
• Research Site — Pessac, France
• Research Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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