Skip to main content
OpenTrials
Completed

NCT Number: NCT00570986

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

The purpose of this study is to determine the safety and efficacy of 2 doses of ABT-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 7314, Barrie, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is >= 18 years of age
  • Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis
  • Subject is judged to be in generally good health as determined by the principal investigator

Exclusion criteria

  • Subject has previous exposure to systemic 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 injectible corticosteroids
  • Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant

Treatment and study plan

Placebo

Drug

Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.

ABT-874

Biological

200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.

Primary outcomes

  1. PGA

    Time frame: Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12

  2. PASI

    Time frame: Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12

  3. PGA

    Time frame: Proportion of subjects maintaining a PGA 0/1 response at Week 52

Secondary outcomes

  1. DLQI

    Time frame: Change from Baseline in DLQI total score vs. placebo at Week 12

  2. NAPSI

    Time frame: % change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis

  3. PASI

    Time frame: Subjects who achieve PASI 90 and 100 at Week 12

  4. Safety parameters

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 11, 2007
Registry last updated
Feb 8, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.