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OpenTrials
Completed

NCT Number: NCT00626002

Open Label Continuation Study in Moderate to Severe Psoriasis

The purpose of this study is to evaluate long term safety, efficacy and tolerability of ABT-874 in adults with moderate to severe 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# 16845, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having participated in a preceding ABT-874 clinical trial for ABT-874
  • Subject has a clinical diagnosis of moderate to severe plaque psoriasis

Exclusion criteria

  • Subjects who prematurely discontinued in any preceding psoriasis study with ABT-874 other than protocol-required discontinuation

Treatment and study plan

ABT-874

Drug

100mg ABT-874 administered SQ every 4 wks for approximately 204 weeks

Other names: briakinumab

Primary outcomes

  1. Proportion of subjects achieving PGA "clear" (0) or "minimal" (1) scores by visit.

    Time frame: Visit (12 weeks)

  2. Proportion of subjects achieving a > PASI 50 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.

    Time frame: Visit (12 weeks)

  3. Proportion of subjects achieving a > PASI 75 clinical response that is defined as a reduction on PASI scores by at least 50% relative to Baseline, by visit.

    Time frame: Visit (12 weeks)

  4. AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study

    Time frame: Visit (12 weeks)

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Phase 3, Multi-center, Open-label Continuation Study in Moderate to Severe Plaque Psoriasis in Subjects Who Completed a Preceding Psoriasis Study With ABT-874

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 29, 2008
Registry last updated
Jan 30, 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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