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Completed

NCT Number: NCT00292396

Efficacy and Safety of ABT-874 in Subjects With Moderate to Severe Chronic Plaque Psoriasis

The purpose of the study is to assess the safety and efficacy of ABT-874 in the treatment of moderate to severe chronic plaque psoriasis.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 3361, Halifax, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
  • Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion criteria

  • Subject had previously received systemic or biologic anti-IL-12 therapy
  • Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
  • Subject is taking or requires oral or injectable corticosteroids
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant

Treatment and study plan

Anti IL-12 monoclonal antibody/ABT-874

Drug

Please see Arm Description for intervention description and details.

Placebo

Drug

12 doses

Primary outcomes

  1. Proportion of subjects with clinical response relative to Baseline PASI score

    Time frame: Week 12, Week 40 and Week 60

Secondary outcomes

  1. Quality of Life Surveys

    Time frame: Week 12, Week 48 and Week 60

  2. Clinical response indicators

    Time frame: Week 12, Week 48 and Week 60

  3. Safety parameters

    Time frame: Monthly through duration of study

  4. PGA Assessment

    Time frame: Week 12, Week 40 and Week 60

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Subcutaneous Injections of ABT-874 vs. Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Feb 16, 2006
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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