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NCT02161757 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Uncontrolled Asthma, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
1,207
Enrollment target
20
Study locations

NCT02161757: Completed Phase 3 study of Uncontrolled Asthma, sponsored by AstraZeneca.

NCT02161757 is a Phase 3 study of Uncontrolled Asthma that has completed, run by AstraZeneca. The registered enrollment target is 1,207 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02161757, a Phase 3 study of Uncontrolled Asthma, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
1,207 participants
Enrollment target
20
Study locations

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

Primary Outcome

Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined

Conditions Studied

Uncontrolled Asthma

Interventions

  • OTHER Placebo
  • BIOLOGICAL Tralokinumab

Study Locations (20)

California

  • Research Site - Arcadia
  • Research Site - Los Angeles
  • Research Site - Los Angeles
  • Research Site - Newport Beach
  • Research Site - Poway
  • Research Site - San Jose
  • Research Site - Tustin
  • Research Site - Wildomar

Florida

  • Research Site - Clearwater
  • Research Site - Coral Gables
  • Research Site - Cutler Bay
  • Research Site - Fort Lauderdale
  • Research Site - Hialeah
  • Research Site - Hialeah

Colorado

  • Research Site - Colorado Springs
  • Research Site - Denver
  • Research Site - Denver

Alabama

  • Research Site - Birmingham

Arizona

  • Research Site - Phoenix

Connecticut

  • Research Site - New Haven

Trial Details

FieldValue
Enrollment Target 1,207 participants
Start Date 2014-06-13
Est. Completion 2017-07-18
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT02161757 record still lists

NCT02161757 is an interventional study that assigns participants to a tested intervention. Its 1,207 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher).

The record links to 1 condition, with Uncontrolled Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02161757 names 20 study sites across 6 states, led by California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT02161757 about?

NCT02161757 is a clinical study titled "A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma". 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

What is the current status of trial NCT02161757?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,207 participants. The study started on 2014-06-13. Estimated completion is 2017-07-18.

What conditions does trial NCT02161757 study?

This clinical trial studies the following conditions: Uncontrolled Asthma.

What interventions are being tested in trial NCT02161757?

The interventions under investigation include: Placebo (OTHER), Tralokinumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02161757?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02161757 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT02161757's enrollment target sits among peer trials

1,207 218th of 2000 higher than 1,782 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02161757, the US trial registry maintained by the National Library of Medicine. NCT02161757 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.