Trial of CF101 to Treat Patients With Psoriasis

Phase 2

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo oral tablets
CF101 2 mg	CF101	CF101 2mg oral tablets

Primary Outcome Measures

Name	Time	Method
Number of Subjects Achieving Psoriasis Area and Severity Index (PASI) 75 at 12 Weeks	12 weeks	Achievement of PASI 75 indicates a 75% reduction in the PASI score, which ranges from 0 (no disease) to 72 (maximal disease)

Secondary Outcome Measures

Name	Time	Method
Numberof Patients Achieving Psoriasis Area and Severity (PASI) Score of 50 or 75	16 weeks	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)
Number of Subjects Achieving PGA of 0 or 1	16 weeks	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)
Nature and Frequency of Adverse Events	32 weeks	Assessment of safety of CF101 in this patient population by gathering adverse event data based on history, vital signs, physical examination, and laboratory data

Locations (18): Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
City Center for Skin and Venereal Disease
🇧🇬
Sofia, Bulgaria
Haemek Medical Center
🇮🇱
Afula, Israel
MHAT Varna at MMA Sofia
🇧🇬
Varna,, Bulgaria
Rambam Medical Center
🇮🇱
Haifa, Israel
Centrul Medical Euromed
🇷🇴
Bucuresti, Romania
Spitalul Clinic Judetean de Urgenta Constanta
🇷🇴
Constanta,, Romania
Spit Clinic Judetean de Urgenta Sf Spiridon Iasi
🇷🇴
Iasi, Romania
MHAT "Doverie"
🇧🇬
Sofia, Bulgaria
Multiprofile Hospital for Active Ttreatment
🇧🇬
Stara Zagora, Bulgaria
DCC "Fokus-5"-MIOC, EOOD
🇧🇬
Sofia,, Bulgaria
Military Medical Acdemy (MMA)
🇧🇬
Sofia, Bulgaria
UMHAT "G.stranski"
🇧🇬
Pleven, Bulgaria
MHAT "Tokuda hospital Sofia"
🇧🇬
Sofia,, Bulgaria
Rabin Medical Center
🇮🇱
Petah Tiqva, Israel
Spitalul Clinic Dermato-Venerice
🇷🇴
Bucuresti, Romania
Emergency County Clinical Hospital
🇷🇴
Cluj-Napoca, Romania
County Clinical Emergency Hospital
🇷🇴
Sibiu, Romania