Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
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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.
To Establish a 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 and to Identify an Appropriate Dose Regimen for Future Trials [ Time Frame: Baseline and 12 weeks ]
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.
Secondary Outcome Measures
Percent of Body Surface Area (BSA) Affected by Psoriasis [ Time Frame: Baseline and Week 12 ]
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 ion percentage of BSA has occurred.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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