Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis. (PRIME)

Novartis

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Biological: Secukinumab; Drug: Fumaric acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02474082

CAIN457ADE06

Details and patient eligibility

About

This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24.

Enrollment: 202 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Men or women must be at least 18 years of age at the time of screening
• Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization 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
• Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.

Exclusion Criteria (abbreviated):

• Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline
• Ongoing use of other prohibited psoriasis and non-psoriasis treatment.
• Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations
• Patients with severe liver diseases
• Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers
• Patients with severe kidney diseases or serum creatinine above 1 x ULN
• Patients with known hematological disease or lab abnormalities
• Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups

Secukinumab

Experimental group

Description:

Patients in treatment arm A will receive a dose of 300 mg secukinumab administered as 2 subcutaneous injections of 150 mg in a SensoReady pen (i.e. 2 x 150 mg) at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20.

Treatment:

Biological: Secukinumab

Fumaric acid (initial and maintenance therapy)

Active Comparator group

Description:

Participants were daily self-administered with fumaric acid derivatives initial and maintenance therapy in dosetitrated scheme as per protocol. Dose was up-titrated weekly (1 tablet/day) until objective was achieved or until tapering was required or until the maximum dose of 2 tablets each at morning, noon and evening was reached, whichever occurred earlier.

Treatment:

Drug: Fumaric acid