Safety and Efficacy Study of CF101 to Treat Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: CF101 1mg; CF101 2mg; CF101 4mg; Placebo
Intervention description: CF101 1 mg q12 hours for 12 weeks; CF101 2 mg q12 hours for 12 weeks; CF101 4 mg q12 hours for 12 weeks; Placebo tablets q12 hours for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      This study will test the hypothesis that CF101, which is under development to treat other
      immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of
      chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated
      every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of
      treatment will be carefully assessed through clinical and laboratory monitoring. The effect
      of treatment on psoriasis will be evaluated through standard techniques of examination and
      measurement of the severity of skin involvement.
    

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.