Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Registration Number
- NCT01815723
- Lead Sponsor
- Forward-Pharma GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FP187 FP187 500 mg FP187 daily (250 mg twice daily) FP187 Fumaderm® placebo 500 mg FP187 daily (250 mg twice daily) Dimethyl fumarate Dimethyl fumarate 720 mg Fumaderm® daily (240 mg three times daily) Dimethyl fumarate FP187 placebo 720 mg Fumaderm® daily (240 mg three times daily) Placebo FP187 placebo Matching FP187 and Fumaderm® placebo Placebo Fumaderm® placebo Matching FP187 and Fumaderm® placebo
- Primary Outcome Measures
Name Time Method 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) after 20 weeks of treatment Achieving a score of clear or almost clear or a 2 step improvement on a 6-point scale as compared to baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Probity Medical Research
🇨🇦Waterloo, Ontario, Canada