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

Phase 3

Completed

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

• Registration Number: NCT00691964
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2011-09-09
• Disposition First Submitted QC: 2011-09-09
• Disposition First Posted: 2011-09-21
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-11
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ABT-874	-
B	etanercept	-
C	placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12	12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12	12 Weeks

Trial Locations

Locations (35)

Site Reference ID/Investigator# 8478; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 8462; 🇺🇸 Fresno, California, United States

Site Reference ID/Investigator# 8454; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator# 8476; 🇺🇸 Denver, Colorado, United States

Site Reference ID/Investigator# 9641; 🇺🇸 Miami, Florida, United States

Site Reference ID/Investigator# 8463; 🇺🇸 Alpharetta, Georgia, United States

Site Reference ID/Investigator# 8479; 🇺🇸 Arlington Heights, Illinois, United States

Site Reference ID/Investigator# 8527; 🇺🇸 Schaumburg, Illinois, United States

Site Reference ID/Investigator# 9001; 🇺🇸 Skokie, Illinois, United States

Site Reference ID/Investigator# 8466; 🇺🇸 West Dundee, Illinois, United States

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