Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

• Status: Completed
• Trial end date: 2018-07-09
• Target enrollment: 0
• Participant gender: All

Summary

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

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

Details

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

Criteria

Inclusion Criteria:

• Subjects must give a written, signed and dated informed consent

• Chronic plaque-type psoriasis present for at least 6 months before randomization

• Moderate to severe plaque psoriasis as defined at randomization by:

• PASI score of ≥12 and

• Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and

• IGA mod 2011 ≥3 (based on a scale of 0-4)

• Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:

• Topical treatment (including topical corticosteroids) and/or

• Phototherapy and/or

• Previous systemic therapy

Exclusion Criteria:

• Forms of psoriasis other than plaque psoriasis

• Drug-induced psoriasis

• Ongoing use of prohibited treatments

• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23

• Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation

• Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply