Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Study Overview
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Brief Summary
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The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.

Detailed Description
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The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: 70 mg SC
* Drug: 210 mg SC
* Drug: 140 mg SC
* Drug: 280 mg SC
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has had stable moderate to severe plaque psoriasis for at least 6 months Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator. Subject has involved BSA ≥ 10% and PASI ≥ 12 at screening and at baseline. Exclusion Criteria: Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication-exacerbated psoriasis. Evidence of skin conditions at the time of the screening visit (eg, eczema, guttate psoriasis) that would interfere with evaluations of the effect of IP on psoriasis. Subject has any active CTCAE grade 2 or higher infection Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol. Subject has used the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids Subject has used the following therapies within 28 days of the first dose: Class I or II topical steroids, UVA therapy (with or without psoralen), or systemic psoriasis therapies Subject has used the following therapies within 3 months of the first dose: adalimumab, alefacept, etanercept, infliximab, certolizumab, or live vaccines Subject has used an anti-IL12/IL23 inhibitor within 6 months of the first dose Subject has previously used an anti-IL17 biologic therapy, efalizumab, or rituximab

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: 140 mg SC<br>140 mg SC | Drug: 140 mg SC<br>* 140 mg SC<br>* Other names: AMG 827;|
| Experimental: 70 mg SC<br>70 mg SC | Drug: 70 mg SC<br>* 70 mg SC<br>* Other names: AMG 827;|
| Experimental: 280 mg SC<br>280 mg SC | Drug: 280 mg SC<br>* 280 mg SC<br>* Other names: AMG 827;|
| Placebo Comparator: 210 mg SC<br>210 mg SC | Drug: 210 mg SC<br>* 210 mg SC<br>* Other names: AMG 827;|
| Experimental: Placebo<br>Placebo | Drug: Placebo<br>* Placebo SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 | At screening a subject would need to have a PASI score of equal to or greater than 12, so at week 12 they were assessed to see percentage of change from there baseline PASI score. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent of Body Surface Area (BSA) Affected by Psoriasis | To evaluate the efficacy of AMG 827 as measured by the following: Body surface area (BSA) involvement at weeks 12. At the baseline of the study the subject would need to have at least a 10% BSA; at week 12 they were again assessed to see what change in percentage of BSA has occurred. | Baseline and Week 12 |