A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Uncontrolled Asthma

In brief

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 Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

Key facts

Study ID

NCT02194699

Run by

AstraZeneca

People needed

856

Starts

2014-10-30

Expected to finish

2017-09-21

Last updated by the study team

2018-05-15

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Hoover, Alabama, United States
• Research Site — Huntsville, Alabama, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Bakersfield, California, United States
• Research Site — Buena Park, California, United States
• Research Site — Encinitas, California, United States
• Research Site — Lakewood, California, United States
• Research Site — Lomita, California, United States
• Research Site — Northridge, California, United States
• Research Site — Palmdale, California, United States
• Research Site — Roseville, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Ventura, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Centennial, Colorado, United States
• Research Site — Celebration, Florida, United States
• Research Site — DeLand, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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