Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.

Official Title
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A Randomised, Double Blind, Double Dummy, Active Comparator and Placebo Controlled Confirmative Non-inferiority Trial of FP187 Compared to Fumaderm® in Moderate to Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: FP187
* Drug: Dimethyl fumarate
* Drug: FP187 placebo
* Drug: Fumaderm® placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; clinical diagnosis of stable moderate to severe plaque psoriasis for at least 6 months; clinical diagnosis of plaque psoriasis with an affected body surface area of no less than 10% and least 10 on the PASI scale and on the sPGA score at least as moderate; Besides psoriasis, patient is in good general health Patients with a DLQI score of at least 10 Exclusion Criteria: Pustular forms of psoriasis, erythrodermic or guttate psoriasis; Known immunosuppressive diseases; Presence of another serious or progressive disease including skin malignancies; Active skin disease; Use of topical medical treatment or UVB treatment during the 2 weeks preceding randomization; Use of systemic anti-psoriatic treatment preceding randomization: methotrexate, cyclosporine, steroids or PUVA (psoralen + UVA treatment) treatment within 4 weeks; biological treatment within 12 weeks; Stelara within 20 weeks; acitretin within 6 months; Treatment with Fumaderm® or other Dimethyl Fumarate containing products within 12 weeks prior randomization; Treatment with drugs influencing the course of psoriasis (e.g., antimalarial drugs, lithium) within 4 weeks prior to randomization; Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within 3 months prior to randomization; On-going stomach or intestinal problems; Aspartate transaminase (AST), Alanine transaminase (ALT) > 2 x upper normal limit (ULN), or Gamma-glutamyltransferase (γ-GT) > 2.5 x ULN; Creatinine Clearance < 60 ml/min; Leucopenia, eosinophilia or lymphopenia; Protein in the urine test;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FP187<br>500 mg FP187 daily (250 mg twice daily) | Drug: FP187<br>* 500 mg FP187 daily, two tablets of 125 mg twice daily, from 125 mg daily up-titrated to full dose over a 4-week phase, total treatment phase of 20 weeks<br>Drug: Fumaderm® placebo<br>* Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm<br>|
| Active Comparator: Dimethyl fumarate<br>720 mg Fumaderm® daily (240 mg three times daily) | Drug: Dimethyl fumarate<br>* 720 mg Fumaderm® daily, two tablets of 120 mg three times daily, from 30 mg daily up-titrated to full dose over a 9-week phase, total treatment phase of 20 weeks<br>* Other names: Fumaderm®;Drug: FP187 placebo<br>* FP187 matching placebo tablets in the same regimen as for FP187 arm<br>|
| Placebo Comparator: Placebo<br>Matching FP187 and Fumaderm® placebo | Drug: FP187 placebo<br>* FP187 matching placebo tablets in the same regimen as for FP187 arm<br>Drug: Fumaderm® placebo<br>* Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving a 75% reduction in their Psoriasis Area and Severity Index (PASI75) score from baseline |  | after 20 weeks of treatment | 
| Responder rate of Static Physician's Global Assessment (sPGA) | Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline. | after 20 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, Dimethyl fumarate, Fumaderm®