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Completed

NCT Number: NCT00710580

Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque psoriasis

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Key information

Conditions

Moderate to Severe Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 10605, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Psoriasis for 6 MO
  • BSA 10%
  • PASI 12 or above
  • PGA 3 or above

Exclusion criteria

  • Previous exposure to either etanercept or ABT-874

Treatment and study plan

ABT-874

Biological

SQ injection 200 mg Weeks 0 and 4; 100 mg Week 8

etanercept

Biological

SQ injection 50 mg BIW

Placebo

Drug

SQ placebo injections for ABT-874 and etanercept

Primary outcomes

  1. Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12

    Time frame: 12 Weeks

  2. Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12

    Time frame: 12 Weeks

Secondary outcomes

  1. Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

  • Paragon Biomedical

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2008
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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