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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01101100
First received: April 1, 2010
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: AMG 827
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 362 weeks ] [ Designated as safety issue: Yes ]
  • Change in laboratory parameters and vital signs [ Time Frame: 360 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) [ Time Frame: 360 weeks ] [ Designated as safety issue: No ]
  • Percent improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 360 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects with a 50% improvement in PASI (PASI 50), PASI 75, PASI 90, and PASI 100 [ Time Frame: 360 weeks ] [ Designated as safety issue: No ]
  • Body surface area (BSA) involvement [ Time Frame: 360 weeks ] [ Designated as safety issue: No ]

Enrollment: 181
Study Start Date: April 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AMG 827
210 mg SC or 140 mg SC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101100

Locations
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
St. 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
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01101100     History of Changes
Other Study ID Numbers: 20090403
Study First Received: April 1, 2010
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Australia: Therapeutic Goods Administration
Canada: Health Canada

Keywords provided by Amgen:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 23, 2014