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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Anti IL-12 monoclonal antibody/ABT-874
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anti IL-12 monoclonal antibody/ABT-874, up to 12 weeks, 200 mg every week for 12 weeks | Drug: Anti IL-12 monoclonal antibody/ABT-874<br>* Please see Arm Description for intervention description and details.<br>|
| Active Comparator: 2<br>Anti IL-12 monoclonal antibody/ABT-874, 200 mg QOW for 12 weeks | Drug: Anti IL-12 monoclonal antibody/ABT-874<br>* Please see Arm Description for intervention description and details.<br>|
| Active Comparator: 3<br>Anti IL-12 monoclonal antibody/ABT-874, 100 mg QOW in 12 weeks | Drug: Anti IL-12 monoclonal antibody/ABT-874<br>* Please see Arm Description for intervention description and details.<br>|
| Active Comparator: 4<br>Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 4 doses in 12 weeks | Drug: Anti IL-12 monoclonal antibody/ABT-874<br>* Please see Arm Description for intervention description and details.<br>|
| Active Comparator: 5<br>Anti IL-12 monoclonal antibody/ABT-874, 200 mg times 1 dose in 12 weeks | Drug: Anti IL-12 monoclonal antibody/ABT-874<br>* Please see Arm Description for intervention description and details.<br>|
| Placebo Comparator: 6<br>placebo, 12 doses | Drug: placebo<br>* 12 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with clinical response relative to Baseline PASI score |  | Week 12, Week 40 and Week 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |