A 24-week, randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm® in adults with moderate to severe plaque psoriasis - PRIME

ovartis Pharma GmbH0 sites200 target enrollmentStarted: February 6, 2015Last updated: October 10, 2016

Overview

No summary available.

•1\. Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator, and must give a written, signed and dated informed consent before any study related activity is performed.
•2\. Men or women must be at least 18 years of age at the time of screening
•3\. Chronic plaque\-type psoriasis diagnosed for at least 6 months before randomization
•4\. Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:
•\- PASI score of \>10
•\- Affected body surface area (BSA) \> 10%
•\- DLQI \>10
•5\. Patients for whom topical psoriasis treatment alone is no longer sufficient. Inadequate response, intolerance or contraindication to topical psoriasis treatment must have been documented in the patient’s medical history or reported by the patient or determined by the investigator at screening.
•6\. Patients for whom Fumaderm® is expected to be the patient\-individually optimized standard therapy under consideration of Fumaderm®, Ciclosporin, Methotrexate or phototherapy (Balneophototherapy, oral PUVA, NB\-UVB) as per investigator’s discretion.
•Are the trial subjects under 18? no

•1\. Forms of psoriasis other than plaque psoriasis
•2\. Drug\-induced psoriasis
•3\. Previous exposure to biologic drugs directly targeting IL\-17A or IL\-17RA, or prior treatmt. with Fumaderm® or other fumaric acid derivatives
•4\. Previous systemic treatmt. of plaque psoriasis or known contraindication for systemic therapy at baseline
•5\. Ongoing use of other prohibited psoriasis \+ non\-psoriasis treatmt. Washout periods detailed in the prot. have to be adhered to. All other previous non\-psoriasis concomitant treatmt. must be on a stable dose at least 4 wks. before randomization
•6\. Plans for admin. of live vaccines during the study period
•7\. Use of any other investigational drugs within 4 wks. of study drug initiation or within a period of 5 half\-lives of the investigational treatmt., whichever is longer
•8\. Known hypersensitivity to secukinumab and/or other components of secukinumab, i.e. sucrose, L\-histidine, L\-histidine hydrochloride monohydrate, polysorbate 80, L\-methionine
•9\. Pats. with latex hypersensitivity
•10\. Known hypersensitivity to fumaric acid derivatives, or other components of Fumaderm® INITIAL/Fumaderm®

Sponsor

ovartis Pharma GmbH