Trial of CF101 to Treat Patients With Psoriasis

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of Daily CF101 Administered Orally in Patients With Moderate-to-Severe Plaque Psoriasis

Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 16 weeks. All subjects will receive open-lable CF101 in weeks 17-32.

Eligible patients will be randomly assigned to parallel dosing groups of CF101 2 mg or matching placebo tablets twice daily (BID) in a 1:1 ratio for the 16-week controlled treatment period. Approximately 94 patients will be assigned to each group.

Medication will be taken orally BID for 16 weeks in a double-blinded fashion. At the end of 16 weeks, all patients assigned to CF101 will continue CF101, while patients originally assigned to placebo will be reassigned to CF101.

Assessment of peripheral blood mononuclear cell (PBMC) adenosine A3 receptor (A3AR) expression at baseline and during treatment with CF101 in selected sites.

Inclusion Criteria:

• Male or female, 18 to 80 years of age, inclusive
• Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%
• Duration of psoriasis of at least 6 months
• Physician global assessment (PGA) ≥3
• Candidate for systemic treatment or phototherapy for psoriasis
• Electrocardiogram (ECG) is normal
• Females of child-bearing potential must have a negative serum pregnancy test
• Females of child-bearing potential must be willing to use 2 methods of contraception
• Ability to complete the study in compliance with the protocol
• Ability to understand and provide written informed consent.

Exclusion Criteria:

• Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis
• Treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the Baseline visit
• Treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the Baseline visit
• Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit
• Treatment with a biological agent within a period of time equal to 5 times its circulating half-life
• Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit
• Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal
• Liver aminotransferase levels greater than the laboratory's upper limit of normal
• Significant acute or chronic medical or psychiatric illness
• Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to Screening visit.