Trial of CF101 to Treat Patients With Psoriasis

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: CF101
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CF101 2 mg<br>CF101 2mg oral tablets | Drug: CF101<br>* orally q12h<br>* Other names: IB-MECA;|
| Placebo Comparator: Placebo<br>Placebo oral tablets | Drug: Placebo<br>* orally q12h<br>* Other names: Dummy pills;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 32 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Plaque psoriasis