Plaque Psoriasis
Conditions
Keywords
Psoriasis, Dimethyl fumarate, Fumaderm®
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.
Interventions
DRUGFP187
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
DRUGDimethyl fumarate
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
DRUGFP187 placebo
FP187 matching placebo tablets in the same regimen as for FP187 arm
DRUGFumaderm® placebo
Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm
Sponsors
Forward-Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed