Clinical trial NCT00428974 (phase 2, status: completed)
Conditions: plaque psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: cf101 1mg, cf101 2mg, cf101 4mg, placebo
SMILES: CNC(=O)[C@H]1O[C@H]([C@H](O)[C@@H]1O)N1C=NC2=C(NCC3=CC(I)=CC=C3)N=CN=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 70 years of age, inclusive;

          -  Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area
             involvement ≥10%, as judged by the Investigator;

          -  Duration of psoriasis of at least 6 months;

          -  PASI score ≥10;

          -  Body weight ≤100 kg;

          -  Candidate for systemic treatment or phototherapy for psoriasis;

          -  ECG is normal or shows abnormalities which, in the judgment of the Investigator, are
             not clinically significant;

          -  Females of child-bearing potential must have a negative serum pregnancy test at
             screening;

          -  Females of child-bearing potential must be willing to use 2 methods of contraception
             deemed adequate by the Investigator (for example oral contraceptive pills plus a
             barrier method) to be eligible for, and continue participation in, the study;

          -  Ability to complete the study in compliance with the protocol; and

          -  Ability to understand and provide written informed consent.

        Exclusion Criteria:

          -  Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis;

          -  Treatment with systemic retinoids, corticosteroids, or immunosuppressants (e.g.,
             methotrexate, cyclosporine) within 6 weeks of the Baseline visit;

          -  Treatment with high potency topical corticosteroids (Class I-III), keratolytics, or
             coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the
             Baseline visit;

          -  Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated
             need for either of these therapies during the study period;

          -  Treatment with a biological agent (including etanercept, adalimumab, efalizumab,
             infliximab, or alefacept) within a period of time equal to 5 times its circulating
             half-life, or 30 days, whichever is longer, prior to the Baseline visit;

          -  History of poor clinical response to methotrexate after an adequate regimen and
             duration of treatment;

          -  Treatment with systemic nonsteroidal anti-inflammatory drugs, beta-blockers, lithium,
             hydroxychloroquine, chloroquine, or systemic terbinafine within 2 weeks of the
             Baseline visit, or anticipated need for such drugs during the study period;

          -  Presence or history of uncontrolled asthma;

          -  Presence or history of uncontrolled arterial hypertension or symptomatic hypotension;

          -  Significant cardiac arrhythmia or conduction block, congestive heart failure (New York
             Heart Association Class 3-4), or any other evidence of clinically significant heart
             disease or clinically significant findings on screening electrocardiogram;

          -  Hemoglobin level <9.0 gm/L;

          -  Platelet count <125,000/mm^3;

          -  White blood cell count <3500/mm^3;

          -  Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal;

          -  Liver aminotransferase levels greater than 2 times the laboratory's upper limit of
             normal;

          -  Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the
             Investigator;

          -  History of malignancy within the past 5 years (excluding basal cell carcinoma of the
             skin and ≤3 cutaneous squamous cell carcinomas, all of which have been completely
             excised);

          -  Significant acute or chronic medical or psychiatric illness that, in the judgment of
             the Investigator, could compromise patient safety, limit the patient's ability to
             complete the study, and/or compromise the objectives of the study;

          -  Participation in another investigational drug or vaccine trial concurrently or within
             30 days; or within 5 half lives of a biological investigational product, whichever is
             longer;

          -  Other conditions which would confound the study evaluations or endanger the safety of
             the patient.