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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: Anti IL-12 monoclonal antibody/ABT-874; Drug: placebo

• Registration Number: NCT00292396
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-16
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Disposition First Submitted: 2011-08-22
• Disposition First Submitted QC: 2011-08-22
• Disposition First Posted: 2011-08-25
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-10
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anti IL-12 monoclonal antibody/ABT-874	Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks
2	Anti IL-12 monoclonal antibody/ABT-874	Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks
3	Anti IL-12 monoclonal antibody/ABT-874	Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks
4	Anti IL-12 monoclonal antibody/ABT-874	Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks
5	Anti IL-12 monoclonal antibody/ABT-874	Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks
6	placebo	placebo, 12 doses

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with clinical response relative to Baseline PASI score	Week 12, Week 40 and Week 60

Secondary Outcome Measures

Name	Time	Method
Quality of Life Surveys	Week 12, Week 48 and Week 60
Clinical response indicators	Week 12, Week 48 and Week 60
Safety parameters	Monthly through duration of study
PGA Assessment	Week 12, Week 40 and Week 60

Trial Locations

Locations (24)

Site Reference ID/Investigator# 990; 🇺🇸 Boston, Massachusetts, United States

Site Reference ID/Investigator# 994; 🇺🇸 Nashville, Tennessee, United States

Site Reference ID/Investigator# 3347; 🇺🇸 Alpharetta, Georgia, United States

Site Reference ID/Investigator# 3349; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 3346; 🇺🇸 Johnston, Rhode Island, United States

Site Reference ID/Investigator# 796; 🇺🇸 Houston, Texas, United States

Site Reference ID/Investigator# 987; 🇨🇦 London, Canada

Site Reference ID/Investigator# 3364; 🇨🇦 Montreal, Canada

Site Reference ID/Investigator# 2081; 🇺🇸 Salt Lake City, Utah, United States

Site Reference ID/Investigator# 992; 🇺🇸 Cincinnati, Ohio, United States

Site Reference ID/Investigator# 989; 🇺🇸 Seattle, Washington, United States

Site Reference ID/Investigator# 3348; 🇺🇸 Skokie, Illinois, United States

Site Reference ID/Investigator# 3350; 🇺🇸 Dallas, Texas, United States

Site Reference ID/Investigator# 3361; 🇨🇦 Halifax, Canada

Site Reference ID/Investigator# 985; 🇨🇦 Laval, Canada

Site Reference ID/Investigator# 795; 🇨🇦 Waterloo, Canada

Site Reference ID/Investigator# 993; 🇺🇸 Indianapolis, Indiana, United States

Site Reference ID/Investigator# 3366; 🇺🇸 Norfolk, Virginia, United States

Site Reference ID/Investigator# 794; 🇨🇦 North Bay, Canada

Site Reference ID/Investigator# 991; 🇺🇸 Lake Oswego, Oregon, United States

Site Reference ID/Investigator# 3360; 🇨🇦 Windsor, Canada

Site Reference ID/Investigator# 3367; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 3351; 🇺🇸 San Diego, California, United States

Site Reference ID/Investigator# 988; 🇨🇦 Quebec City, Canada