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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Placebo
* Biological: ABT-874
* Biological: ABT-874


Participation Criteria
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Eligibility Criteria
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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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Arm #1 is used for entire study. At week 12, arm is rerandomized. | Drug: Placebo<br>* Two injections at weeks 0 and 4. One injection at week 8. At week 12, arm is rerandomized to placebo every 4 weeks.<br>|
| Active Comparator: 2<br>Arm #2 is used for entire study. At week 12, arm is rerandomized. | Biological: ABT-874<br>* 200mg at week 0 and week 4. 100mg at week 8. On week 12, arm is rerandomized to 100mg every 4 weeks.<br>|
| Active Comparator: 3<br>Arm #3 is not used for weeks 0-11. At week 12, arm is rerandomized. | Biological: ABT-874<br>* 100mg every 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PGA |  | Proportion of subjects achieving a PGA 0/1 (Clear or minimal) at Week 12 | 
| PASI |  | Subjects achieving a PASI 75 response defined as a 75% reduction in the PASI score from baseline at Week 12 | 
| PGA |  | Proportion of subjects maintaining a PGA 0/1 response at Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLQI |  | Change from Baseline in DLQI total score vs. placebo at Week 12 | 
| 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 | 
| Safety parameters |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque Psoriasis