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

Novartis Pharmaceuticals202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

202

Conditions

Psoriasis

Interventions

Fumaric acidDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (32)

Novartis Investigative Site

Bad Bentheim, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Outcomes

Primary Outcomes

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24

PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved \>=75% improvement (reduction) in PASI score compared to baseline.

Time frame: Baseline, Week 24

Secondary Outcomes

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24

PASI score is an average degree of severity of signs in head \[H\], trunk \[T\], upper limbs \[U\] and lower limbs \[L\], assessed separately for erythema \[E\], thickening (plaque elevation, induration) \[I\], and scaling (desquamation) \[D\]. Area \[A\] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 50 responders were participants who achieved \>=50% improvement (reduction) in PASI score compared to baseline.