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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
293
Mount Sinai School of Medicine
New York, New York, United States
UMHAT "G.stranski"
Pleven, Bulgaria
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks
Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
Time frame: 12 weeks
Number of Subjects Achieving PGA of 0 or 1
PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe)
Time frame: 16 weeks
Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75
Achievement of PASI 50 or 75 indicates a 50% and 75% reduction respectively in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)
Time frame: 16 weeks
Nature and Frequency of Adverse Events
Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data
Time frame: 32 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MHAT "Tokuda hospital Sofia"
Sofia, Bulgaria
DCC "Fokus-5"-MIOC, EOOD
Sofia, Bulgaria
Military Medical Acdemy (MMA)
Sofia, Bulgaria
MHAT "Doverie"
Sofia, Bulgaria
City Center for Skin and Venereal Disease
Sofia, Bulgaria
Multiprofile Hospital for Active Ttreatment
Stara Zagora, Bulgaria
MHAT Varna at MMA Sofia
Varna, Bulgaria
Haemek Medical Center
Afula, Israel
...and 8 more locations