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

Bausch Health

Status and phase: Terminated; Phase 2

Conditions: Psoriasis

Treatments: Drug: AMG 827

Study type: Interventional

Funder types: Industry

Identifiers

NCT01101100

20090403

Details and patient eligibility

About

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

Full description

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

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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181 participants in 1 patient group

AMG 827

Experimental group

Description:

AMG 827

Treatment:

Drug: AMG 827