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

July 17, 2019 updated by: Bausch Health Americas, Inc.

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

181

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Research Site
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Research Site
      • Prahran, Victoria, Australia, 3181
        • Research Site
  • Canada
      • Quebec, Canada, G1V 4X7
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1V6
        • Research Site
      • London, Ontario, Canada, N6A 3H7
        • Research Site
      • Markham, Ontario, Canada, L3P 1A8
        • Research Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Research Site
      • Windsor, Ontario, Canada, N8W 1E6
        • Research Site
  • Denmark
      • Aarhus, Denmark, 8000
        • Research Site
      • Hellerup, Denmark, 2900
        • Research Site
  • France
      • Besançon, France, 25030
        • Research Site
      • Nice, France, 06200
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
  • United States
    • Georgia
      • Newnan, Georgia, United States, 30263
        • Research Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Research Site
      • Webster, Texas, United States, 77598
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AMG 827
Drug: AMG 827
210 mg SC or 140 mg SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
264 weeks
Percent Change in Psoriasis Area and Severity Index (PASI)
Time Frame: 264 weeks
Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
264 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (ESTIMATE)

April 9, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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