Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
This study is enrolling participants by invitation only.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01101100
First received: April 1, 2010
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing of AMG 827 for up to 264 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: 264 weeks ] [ Designated as safety issue: Yes ]
- Change in laboratory parameters and vital signs [ Time Frame: 264 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: 264 weeks ] [ Designated as safety issue: No ]
- Percent improvement in Psoriasis Area and Severity Index (PASI) [ Time Frame: 264 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: 264 weeks ] [ Designated as safety issue: No ]
- Body surface area (BSA) involvement [ Time Frame: 264 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 155 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: I |
Drug: AMG 827
210 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
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: | July 12, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) United States: Food and Drug Administration Australia: Therapeutic Goods Administration Canada: Health Canada |
Keywords provided by Amgen:
|
Psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013