Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis

Phase 2TerminatedNCT01101100

Bausch Health Americas, Inc.181 enrolled

Overview

This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 362 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

181

Conditions

Psoriasis

Interventions

AMG 827DRUG

210 mg SC or 140 mg SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject was randomized into Study 20090062 and completed the week 16 evaluation. Exclusion Criteria: * Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was considered possibly related to IP. * Subject experienced an adverse event in Study 20090062 that, in the opinion of the investigator, could cause extension of treatment to be detrimental to the subject.

Locations (21)

Research Site

Newnan, Georgia, United States

Research Site

Skokie, Illinois, United States

Outcomes

Primary Outcomes

Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)

Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)

Time frame: 264 weeks

Percent Change in Psoriasis Area and Severity Index (PASI)

Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.

Time frame: 264 weeks

Data from ClinicalTrials.gov

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