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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Bausch Health Americas, Inc.
• Treatments: Antibodies, Monoclonal; Brodalumab

Criteria

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