A multicenter double-blind randomized withdrawal extension study of subcutaneous Secukinumab in prefilled syringes to demonstrate long-term efficacy safety and tolerability up to 2 years in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with Secukinumab. CAIN457A2302E1
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- STATUS
- Not Recruiting
Summary
The purpose of this clinical research study is to find out if the drug Secukinumab (AIN457) is safe and has beneficial (helpful) effects when administered long-term in people who have chronic plaque-type psoriasis and completed the phase III study CAIN457A2302 with at least a partial response at week 52. The prefilled syringe (PFS) liquid formulation of Secukinumab will be used in this study. Although the option is available for subjects to self inject Secukinumab,our 2 subjects have chosen not to self administer study drug therefore it will be done by the study coordinator Study periods will include either a 3 or 4 study period dependent on subject classification at week 52 of core study: 1. Screening period 2. Treatment period 3. Follow-up period or 1. Screening period 2. Randomized withdraw 3. Treatment period 4. Follow-up period. Procedures and tests include Vital signs, Waist and hip measurements,physical exams, subject questionaires, electrocardiograms, blood and urine tests. Main Inclusion Criteria: Subjects who completed the full study treatment period (52 weeks) in the core studie (e.g., CAIN457A2302 ), and after randomization have been receiving secukinumab treatment during the maintenance phase of the core study,and show at least a partial response (PASI 50 or better) at Week 52 of the core study. Main Exclusion criteria: 1. A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject. 2.Ongoing use of prohibited psoriasis or non-psoriasis treatments. 3. Subjects not expected to benefit from participation in the extension study. 4.Pregnant or nursing (lactating) women.
Details
| Age | 1years - 99years |
|---|---|
| Clinical Study Identifier | 816637 |
| Last Modified on | 19 February 2024 |
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