Clinical trial NCT01230138 (phase 2, status: completed)
Conditions: plaque psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: placebo, fp187, fp187, fp187, fp187
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H]\C(=C(\[H])C(=O)OC)C(=O)OC, [H]\C(=C(\[H])C(=O)OC)C(=O)OC, [H]\C(=C(\[H])C(=O)OC)C(=O)OC, [H]\C(=C(\[H])C(=O)OC)C(=O)OC
Eligibility criteria:

        Inclusion 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 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 randomization

          -  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:

               -  Systemic contraceptive (oral, implant, injection),

               -  Intrauterine 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 and
             clinical laboratory parameters (hematology, biochemistry and urinalysis).

        Exclusion 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 plan-ning 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 - Use of systemic anti-psoriatic
             treatment preceding the baseline visit Methotrexate, cyclosporine, steroids or PUVA
             treatment within x weeks; Biological treatment (efalizumab, adalimumab, infliximab,
             etanercept) within xx weeks; Acitretin within x months; Treatment with Fumaderm® or
             other DMF containing products during past xx weeks prior to baseline visit;
             Discontinuation of previous treatment with Fumaderm® or other DMF containing products
             due to lack of efficacy or side effects;

          -  Has within the past x weeks prior to baseline visit been treated with drugs
             influencing the course of the psoriasis such as antimalarial drugs, beta-blockers 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 2x UNL)

          -  Has an estimated Creatinine Clearance: < xx ml/min

          -  Has leucopenia (leukocyte count < x/mm3) or eosinophilia (count >x/µl) or lymphopenia
             (count < x/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 or participation in a trial with treatment of biologicals within x months prior
             to baseline visit

          -  Patients who are involved in the organisation of the clinical investigation or are in
             any way dependant on the investigator or sponsor