Study to assess the Safety, Tolerability, and Long term Efficacy of Secukinumab drug in patients with Moderate to severe Chronic plaque-type Poriasis.

Phase 3

Completed

Brief Summary: Purpose of the Study:

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

FPFV for India: 27-Apr-2012

Enrollment Target for India: 50

Recruitment & Eligibility

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

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.
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.
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.

Primary Outcome Measures

Name	Time	Method
Efficacy of intravenous administration of secukinumab compared with subcutaneous administration secukinumab with respect to both PASI 75 and IGA 0 or 1 response	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Locations (8): A J Institute of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
Dr. Vikrant Saoji Skin Clinic
🇮🇳
Nagpur, MAHARASHTRA, India
Grant Medical college and JJ Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
M.S. Ramaiah Memorial Hospital
🇮🇳
Bangalore, KARNATAKA, India
Owaisi Hospital and research centre
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Radiance skin clinic
🇮🇳
Nagpur, MAHARASHTRA, India
Shree Hospital & critical care,
🇮🇳
Nagpur, MAHARASHTRA, India
Skin Clinic
🇮🇳
Nashik, MAHARASHTRA, India
A J Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Narendra Shetty
Principal investigator
919945613123
drnarendrashetty@yahoo.com