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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01101100
Recruitment Status : Terminated (Sponsor Decision)
First Posted : April 9, 2010
Results First Posted : July 18, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: AMG 827 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis
Study Start Date : April 2010
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: AMG 827
AMG 827
Drug: AMG 827
210 mg SC or 140 mg SC




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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101100


Locations
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United States, Georgia
Research Site
Newnan, Georgia, United States, 30263
United States, Illinois
Research Site
Skokie, Illinois, United States, 60077
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63117
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87106
United States, Texas
Research Site
Dallas, Texas, United States, 75246
Research Site
Webster, Texas, United States, 77598
Australia, New South Wales
Research Site
Kogarah, New South Wales, Australia, 2217
Australia, South Australia
Research Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Research Site
Parkville, Victoria, Australia, 3050
Research Site
Prahran, Victoria, Australia, 3181
Canada, Ontario
Research Site
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
Canada
Research Site
Quebec, Canada, G1V 4X7
Denmark
Research Site
Aarhus, Denmark, 8000
Research Site
Hellerup, Denmark, 2900
France
Research Site
Besançon, France, 25030
Research Site
Nice, France, 06200
Research Site
Toulouse Cedex 9, France, 31059
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: MD Amgen

Additional Information:
Publications:
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01101100     History of Changes
Other Study ID Numbers: 20090403
First Posted: April 9, 2010    Key Record Dates
Results First Posted: July 18, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Bausch Health Americas, Inc.:
Psoriasis

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Brodalumab
Dermatologic Agents