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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02474082
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Secukinumab — BIOLOGICAL
    Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection
  • Fumaric acid — DRUG
    Fumaric acid initial therapy (tablet contains 30 mg dimethylfumarate, 67 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt) and Fumaric acid maintenance therapy (tablet contains 120 mg dimethylfumarate, 87 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt)

Study Details

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.

Key Dates

Start date
Apr 30, 2015
Status verified
Jun 2017
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016

Study Design

Enrollment
202 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Secukinumab
    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.
  • Active Comparator: Fumaric acid (initial and maintenance therapy)
    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.

Primary Outcome Measure

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24 [ Time Frame: Baseline, Week 24 ]

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