A randomised, double blind, placebo controlled efficacy and safety trial of different doses/dose regimens of FP187 compared to placebo in moderate to severe plaque psoriasis.

• Conditions: stable moderate to severe plaque psoriasis (PASI above 10) for at least 6 months prior to study; MedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2010-020168-39-DE
• Lead Sponsor: Forward Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-09
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <1%) medically accepted contraceptive method during the trial as well as one month after trial is finished such as:
oSystemic contraceptive (oral, implant, injection),
oIntrauterine device (IUD) inserted for at least one month prior to study entrance.
•Willingness and ability to comply with the trial procedures.
•Patient is beside the psoriasis disease in good general health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure [upper limit 145/90] pulse rate [between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (hematology, biochemistry and urinalysis). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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):
.1Methotrexate, cyclosporine, steroids or PUVA treatment within 4 weeks,
.2Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within 12 weeks
.3Acitretin 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): < 60 ml/min
•Has leucopenia (leukocyte count < 3500/mm3) or eosinophilia (count > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified