Investigate Effect of Secukinumab on the PK of Midazolam in Patients With Mod to Sev Plaque Psoriasis

• Status: Completed
• Trial end date: 2016-12-20
• Target enrollment: 0
• Participant gender: All

Summary

To determine whether secukinumab can alter the activity of cytochrome P450 (CYP) 3A4 using midazolam as probe substrate in patients with moderate-to-severe plaque psoriasis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Moderate to severe plaque psoriasis as defined at baseline by: PASI score of 12 or greater and IGA mod 2011 score of 3 or greater (based on a scale of 0 - 4) and Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.

• Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy

• Men or women at least 18 years of age or older at time of screening.

Exclusion Criteria:

• Forms of psoriasis other than chronic plaque-type

• Pregnant or nursing (lactating) women,

• History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection.

• Subjects with known history of hypersensitivity to midazolam