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.
This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of moderate-to-severe chronic plaque psoriasis. At the Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, blood pressure, pulse rate and temperature, and clinical laboratory tests. Eligible patients will be those who have not received systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks prior to initiation of study; or high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles); and UV or Dead Sea therapy within 4 weeks prior to initiation of study treatment. Eligible patients will be sequentially assigned to 1 of 3 dosing cohorts: Cohort 1: CF101 1 mg (15 patients) or Placebo (5 patients); Cohort 2: CF101 2 mg (15 patients) or Placebo (5 patients); Cohort 3: CF101 4 mg (15 patients) or Placebo (5 patients). Medication will be taken orally q12h for 12 weeks. Disease activity will be assessed using the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA). Patients will return for assessments at Weeks 2, 4, 8, 12 and 14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Haemek Medical Center
Afula, Israel
Wolfson Medical Center
Holon, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Change From Baseline (CFB) in Psoriasis Area and Severity Index (PASI) Score
PASI scale is sum of redness, thickness, and scale scores, ranging from 0 (no disease) to 72 (most severe possible score); lower scores, i..e., negative change from baseline, indicate improvement
Time frame: 12 weeks minus baseline
The Number of Patients Who Achieve a Score of "Almost Clear" or "Clear" by Physician's Global Assessment (PGA)
PGA is a scale from 0 (clear, no disease) to 5 (most severe score); patients who improve to 0 (clear) or 1 (minimal disease) are tabulated in this outcome
Time frame: 12 weeks
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Enrollment
76
Placebo tablets q12 hours for 12 weeks