Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Fumaric acid
Intervention description: Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection; 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)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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)