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

NCT02161757

Run by

AstraZeneca

People needed

1207

Starts

2014-06-13

Expected to finish

2017-07-18

Last updated by the study team

2018-08-28

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 — Phoenix, Arizona, United States
• Research Site — Arcadia, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Poway, California, United States
• Research Site — San Jose, California, United States
• Research Site — Tustin, California, United States
• Research Site — Wildomar, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Coral Gables, Florida, United States
• Research Site — Cutler Bay, Florida, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Homestead, Florida, United States
• Research Site — Homestead, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Kissimmee, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.