A Multi-center, Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety for 16 Weeks in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A
- Conditions
- Plaque Psoriasis
- Registration Number
- JPRN-jRCT1080222997
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Plaque psoriasis diagnosed for at least 6 months before baseline
-Treated with cyclosporine A for at least 12 weeks prior to baseline
-Currently treated with cyclosporine A at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by:
-PASI score of 10 or greater and
-IGA mod 2011 score of 2 or greater (based on a scale of 0 to 4)
-Forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis).
-Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium).
-Patients who have to discontinue cyclosporine A treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 micromol/L [2.0 mg/dL]) and hypertension at screening.
Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method