Conditions: Plaque Psoriasis
Keywords: Psoriasis Plaque psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 293
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: CF101 2mg oral tablets arm 2: Placebo oral tablets

Interventions: intervention 1: CF101 intervention 2: Placebo
Intervention descriptions: intervention 1: orally q12h intervention 2: orally q12h

Protocol document: