Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
- Registration Number
- NCT01101100
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 181
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMG 827 AMG 827 AMG 827
- Primary Outcome Measures
Name Time Method Percent Change in Psoriasis Area and Severity Index (PASI) 264 weeks Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1) 264 weeks Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇫🇷Toulouse Cedex 9, France