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

Phase 2

Completed

• Conditions: Psoriasis
• Interventions: Drug: 210 mg SC; Drug: 70 mg SC; Drug: 140 mg SC; Drug: 280 mg SC; Drug: Placebo

• Registration Number: NCT00975637
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Study Start: 2009-12
• Primary Completion: 2010-07
• Study Completion: 2010-09
• Disposition First Submitted: 2015-06-22
• Disposition First Submitted QC: 2015-06-22
• Disposition First Posted: 2015-07-15
• Results First Submitted: 2016-11-02
• Results First Submitted QC: 2016-11-02
• Results First Posted: 2016-12-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
210 mg SC	210 mg SC	210 mg SC
70 mg SC	70 mg SC	70 mg SC
140 mg SC	140 mg SC	140 mg SC
280 mg SC	280 mg SC	280 mg SC
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Change in Percent of Body Surface Area (BSA) Affected by Psoriasis	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 in percentage of BSA has occurred.