Psoriasis Clinical Trial
Official title:
A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis
| NCT number | NCT01101100 |
| Other study ID # | 20090403 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | April 2010 |
| Est. completion date | September 2015 |
| Verified date | July 2019 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.
| Status | Terminated |
| Enrollment | 181 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | Adelaide | South Australia |
| Australia | Research Site | Kogarah | New South Wales |
| Australia | Research Site | Parkville | Victoria |
| Australia | Research Site | Prahran | Victoria |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Markham | Ontario |
| Canada | Research Site | Quebec | |
| Canada | Research Site | Waterloo | Ontario |
| Canada | Research Site | Windsor | Ontario |
| Denmark | Research Site | Aarhus | |
| Denmark | Research Site | Hellerup | |
| France | Research Site | Besançon | |
| France | Research Site | Nice | |
| France | Research Site | Toulouse Cedex 9 | |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Newnan | Georgia |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Skokie | Illinois |
| United States | Research Site | Webster | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States, Australia, Canada, Denmark, France,
Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) | Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1) | 264 weeks | |
| Primary | Percent Change in Psoriasis Area and Severity Index (PASI) | Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement. | 264 weeks |
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