Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion criteria:

• Written Informed Consent must be obtained before any assessment is performed,

• Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.

• Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

Exclusion criteria

• Pregnant women or lactating women

• Forms of psoriasis other than chronic plaque -type

• Ongoing use of prohibited psoriasis treatments

• Ongoing use of other non-psoriasis prohibited treatments

• Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304

• Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy

• UV therapy or excessive exposure to sunlight