stable moderate to severe plaque psoriasis (PASI above 10) for at least 6 months prior to study MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: FP 187
Product Code: FP 187
Pharmaceutical Form: Coated tablet
INN or Proposed INN: dimethyl fumarate
CAS Number: 624-49-7
Current Sponsor code: FP 187
Concentration unit: mg milligram(s
Sponsors
Forward Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be entered into this trial only if they meet all of the following criteria: • Patients of either sex at least 18 years of age • A clinical diagnosis of plaque psoriasis defined as skin areas with erythema, induration and scaling, with a body surface area score of no less than 10% and in total to be scoring at least 10 on the PASI scale. • The psoriasis disease have been stable for at least 6 months at randomisation • Signed and dated informed consent, • Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be enrolled if they meet any of the following criteria: • Female patients who are pregnant or breast-feeding or planning to become pregnant up to 7 months from treatment start as well as male patients planning pregnancy with their partner up to 7 months from treatment start or practise unprotected sexual relationship up to 7 months from treatment start. • Known allergy to any of the constituents of the product being tested, • Pustular forms of psoriasis, erythrodermic or guttate psoriasis • Known immunosuppressive diseases (e.g., AIDS/HIV) • Presence of another serious or progressive disease which, according to the Investigator may interfere with treatment outcome, • Active skin disease such as atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome, • Use of topical medical treatment or UVB treatment during the 2 weeks preceding the baseline visit (Day -5), • Use of systemic anti-psoriatic treatment preceding the baseline visit (Day -5): .1 Methotrexate, cyclosporine, steroids or PUVA treatment within 4 weeks, .2 Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within 12 weeks .3 Acitretin within 6 months • Treatment with Fumaderm® or other DMF containing products during past 24 weeks prior to baseline visit (Day -5) • Discontinuation of previous treatment with Fumaderm® or other DMF containing products due to lack of efficacy or side effects • Has within the past 4 weeks prior to baseline visit been treated with drugs influencing the course of the psoriasis such as antimalarial drugs or lithium • Has a relevant clinical history of stomach or intestinal problems (eg gastritis or peptic ulcer within the last 10 years ) • Has liver enzyme measures (AST, ALT,gamma-GT) higher than 2 x UNL • Has an estimated Creatinine Clearance (Cockcroft-Gault): 750/µl) or lymphopenia (count < 1.02/nl). • Has protein in the urine test at screening or baseline visit • Participation in another clinical trial during the last month preceding the baseline visit (Day -5) or participation in a trial with treatment of biologicals within 6 months prior to baseline visit. • Patients who are involved in the organization of the clinical investigation or are in any way dependant on the investigator or sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are to compare and describe the efficacy and safety of different dose levels/regimens of FP187 compared to placebo with regards to: At V6 (week 4), V7 (w 8), V8 (w12), V9 (w16), V12 (w26), V13 (w32), V14 (w40) and V15 (w48): – Proportion of responders achieving PASI 75, At V6 (w4), V7 (w8), V8 (w12), V9 (w16), V10 (w20), V12 (w26), V13 (w32), V14 (w 40) and V15 (w48): – Proportion of responders achieving PASI 50 and PASI 90 – Proportion of responders on the static Physician's Global Assessment score (sPGA) and the actual scores – Patient global assessment score, – Patient QoL score (DLQI), – Patient assessed pruritus, – Exploratory analysis of a possible effect of FP187 on cholesterol and triglycerides – Overall safety and tolerability – To perform a full exploratory analysis as above on the data generated in the subset of patients who has continued with the extended treatment for up to 48 w. and the post treatment follow up. ;Primary end point(s): Proportion of responders, defined as patients achieving PASI 75 (reduction in PASI of at least 75% from baseline) at Visit 10 (Week 20).;Main Objective: To compare the efficacy of two different BID doses and one TID dose of FP187 to placebo after 20 weeks of treatment on proportion of patients achieving PASI 75. | — |
Countries
Germany
Outcome results
None listed