Palmoplantar Pustular Psoriasis Efficacy and Safety wIth Secukinumab

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 237
• Participant gender: Both

Summary

Was to demonstrate superiority of secukinumab compared to placebo in patients with moderate to severe chronic palmoplantar pustular psoriasis with respect to the palmoplantar pustulosis Psoriasis Area and Severity Index 75 response rate

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal
• Last Updated: 2016-09-23

Criteria

Inclusion Criteria:

• Palmoplantar pustular psoriasis for at least 6 months before Randomization

• Moderate to severe palmoplantar pustular psoriasis as defined at

Baseline by:

• ppPASI score of ≥ 12 and

• DLQI ≥ 10

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

• Topical treatment, and/or

• Phototherapy, and/or

• Previous systemic therapy

Exclusion Criteria:

• Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g., erythrodermic, guttate, or generalized pustular psoriasis)

• Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis

• Patients not willing to limit UV light exposure (e.g. sunbathing and/or the use of tanning devices) during the course of the study

• Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to

• Previous exposure to any biologic drug directly targeting IL-17 or IL-17 Receptor (e.g., secukinumab, ixekizumab, or brodalumab)

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment

• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy

• Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer

Other protocol-defined inclusion/exclusion criteria may apply.