Health Condition 1: null- Plaque-type Psoriasis
Conditions
Interventions
Intervention1: secukinumab 300mg: Each Subject will recieve secukinumab 150mg(2 injections per dose)s.c. injections both at randomization and at Week 4plus an i.v. infusion of
100 mL of normal saline
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Informed consent must be obtained before any assessment is performed, where a relevant and legal representative will also sign the informed study consent according to local laws and regulations. 2.Subject must be able to understand and communicate with the investigator and comply with the requirements of the study. 3.Subjects must be participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations. 4.A partial response is defined as having achieved PASI 50 not 75 response.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine test. 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment. 3. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis). 4.Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Ongoing use of other non-psoriasis prohibited treatments. 5.Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304 6. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of intravenous administration of secukinumab compared with subcutaneous administration secukinumab with respect to both PASI 75 and IGA 0 or 1 responseTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy of a higher dose of secukinumab than administered in CAIN457A2304 in achieving PASI 75 or IGA 0 or 1 response over time 2.Efficacy of secukinumab treatment regimens in subjects with respect to PASI 50/75/90/100 response and IGA 0 or 1 response overtime 3.Efficacy treatment regimens with secukinumab with respect to PASI score and IGA mod 2011 score over time. Timepoint: 1.Week 40 2.Week 40 3.Week 40 | — |
Countries
Austria, Canada, Czech Republic, India, Japan, Poland, Slovakia, Switzerland, Taiwan, United States of America, Viet Nam
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited
Outcome results
None listed