A study to compare the efficacy of a new developed product, FP187, to a marketed product, to each other but also to placebo, in patients with moderate to severe plaque psoriasis. The patients will be assigned to one of the three treatment arms by chance,and neither the investigator nor the patient will know the assigned group.
- Conditions
- Moderate to severe plaque psoriasisMedDRA version: 16.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2012-005685-35-DE
- Lead Sponsor
- Forward Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
? Patients of either sex at least 18 years of age
? Patients with a clinical diagnosis of stable moderate to severe plaque psoriasis (PASI value above 10) for at least 6 months prior to trial start will be eligible for randomization for the trial.
? Patients with a clinical diagnosis of plaque psoriasis defined as skin areas with erythema, induration and scaling, with an affected body surface area (BSA)>10% and in total to be scoring > 10 on the PASI scale and on the sPGA score at least as moderate (=3 at the 6-point scale), defined as:
-Systemic treatment naive patients who cannot be controlled in their disease symptoms with a topical treatment and are candidates for systemic treatment; or
- Patients who have failed under treatment with other first or second line systemic treatments.
? Signed and dated informed consent,
? 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:
– Systemic contraceptive (oral, implant, injection),
– Intrauterine device (IUD) inserted for at least one month prior to trial entrance
? Willingness and ability to comply with the trial procedures.
? Besides psoriasis, patient is 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 160/95] pulse rate [between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (haematology, 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.
? Patients have to have a DLQI>10
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 744
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56
? Female patients who are pregnant or breast-feeding or planning to become pregnant during the entire trial period as well as male patients planning pregnancy with their partner during the entire trial period or practice unprotected sexual relationship during the entire trial period.
? Male patients planning pregnancy with their partner during the entire trial period, or practicing unprotected sexual relationship during the entire trial period.
? Known allergy to any of the constituents of the products being tested,
? Pustular forms of psoriasis, erythrodermic or guttate psoriasis,
? Known immunosuppressive diseases (e.g., AIDS/HIV),
? Presence of another serious or progressive disease including skin malignancies, which, according to the Investigator may interfere with treatment outcome,
? Active skin disease such as atopic dermatitis, rosacea, lupus erythematous, 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 Visit 3
? Use of systemic anti-psoriatic treatment preceding Visit 3:
– Methotrexate, cyclosporine, steroids or PUVA treatment within 4 weeks,
– Biological treatment (efalizumab, adalimumab, infliximab, etanercept) within 12 weeks, or Stelara within 20 weeks
– Acitretin within 6 months,
-– Not named drugs should have a wash-out of 5 times their half-life
? Treatment with Fumaderm® or other DMF containing products during the past 12 weeks prior to Visit 3,
? Has within the past 4 weeks prior to Visit 3 been treated with drugs influencing the course of the psoriasis such as antimalarial drugs, or lithium,
? Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within the last 3 month, also if currently kidney functions are normal.
? Has on-going stomach or intestinal problems (e.g. gastritis or peptic ulcer),
? Has liver enzyme results (AST, ALT,) > 2 x upper normal limit (ULN) or gamma-GT results > 2.5 x ULN
? Has an estimated Creatinine Clearance (Cockcroft-Gault): < 60 ml/min,
? Has leucopenia (leukocyte count < 3.5x109/l) or eosinophilia (count > 750/µl) or lymphocytopenia (count < 1.02 x109/l),
? Has protein in the urine stick test at Visit 1 and at Visit 2, and confirmed in a subsequent complete urine analysis
? Participation in another clinical trial during the last two months preceding Visit 3 or participation in a trial with treatment with biologicals within 6 months prior to Visit 3,
? Patients who are involved in the organisation of the clinical investigation or are in any way dependent on the Investigator or sponsor
? Patients in whom Fumaderm® is contraindicated.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method