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

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Biological: ABT-874; Drug: Placebo

• Registration Number: NCT00570986
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-10
• Study First Posted: 2007-12-11
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Disposition First Submitted: 2011-08-18
• Disposition First Submitted QC: 2011-08-18
• Disposition First Posted: 2011-08-23
• Status Verified: 2013-01
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1465

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ABT-874	Arm #2 is used for entire study. At week 12, arm is rerandomized.
3	ABT-874	Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized.
1	Placebo	Arm #1 is used for entire study. At week 12, arm is rerandomized.

Primary Outcome Measures

Name	Time	Method
PGA	Proportion of subjects maintaining a PGA 0/1 response at Week 52
PASI	Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12

Secondary Outcome Measures

Name	Time	Method
NAPSI	% change in NAPSI score at Week 12 vs placebo in subjects with nail psoriasis
PASI	Subjects who achieve PASI 90 and 100 at Week 12
DLQI	Change from Baseline in DLQI total score vs. placebo at Week 12
Safety parameters	Throughout study

Trial Locations

Locations (116)

Site Reference ID/Investigator# 6579; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 6697; 🇺🇸 Birmingham, Alabama, United States

Site Reference ID/Investigator# 7015; 🇺🇸 Huntsville, Alabama, United States

Site Reference ID/Investigator# 6728; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 6584; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 6696; 🇺🇸 Little Rock, Arkansas, United States

Site Reference ID/Investigator# 6591; 🇺🇸 Bakersfield, California, United States

Site Reference ID/Investigator# 6710; 🇺🇸 Fresno, California, United States

Site Reference ID/Investigator# 7885; 🇺🇸 Irvine, California, United States

Site Reference ID/Investigator# 6872; 🇺🇸 Los Angeles, California, United States

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