A Phase 2, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of the Safety and Activity of Daily CF101 Administered Orally in Patients with Moderate-to-Severe Plaque Psoriasis - NA

Active, not recruiting

• Conditions: Patients with Moderate-to-Severe Plaque Psoriasis; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2008-005904-13-BG
• Lead Sponsor: Can-Fite BioPharma, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Male or female, 18 to 70 years of age, inclusive;
2.Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement =10%, as judged by the Investigator;
3.Duration of psoriasis of at least 6 months;
4.PASI score =10;
5.Body weight =100 kg;
6.Candidate for systemic treatment or phototherapy for psoriasis;
7.Electrocardiogram (ECG) is normal or shows abnormalities which, in the judgment of the Investigator, are not clinically significant;
8.Females of child-bearing potential must have a negative serum pregnancy test at screening;
9.Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
10.Ability to complete the study in compliance with the protocol; and
11.Ability to understand and provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis;
2.Treatment with systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks of the Baseline visit;
3.Treatment with high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit;
4.UV or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
5.Treatment with a biological agent (including etanercept, adalimumab, efalizumab, infliximab, or alefacept) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline visit;
6.History of poor clinical response to methotrexate after an adequate regimen and duration of treatment;
7.Treatment with systemic nonsteroidal anti-inflammatory drugs, beta-blockers, lithium, hydroxychloroquine, chloroquine, or systemic terbinafine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period;
8.Presence or history of uncontrolled asthma;
9.Presence or history of uncontrolled arterial hypertension or symptomatic hypotension;
10.Significant cardiac arrhythmia or conduction block, congestive heart failure (New York Heart Association Class 3-4), or any other evidence of clinically significant heart disease or clinically significant findings on screening ECG;
11.Hemoglobin level <9.0 gm/L;
12.Platelet count <125,000/mm3;
13.White blood cell (WBC) count <3500/mm3;
14.Serum creatinine level greater than 1.5 times the laboratory’s upper limit of normal;
15.Liver aminotransferase levels greater than 2 times the laboratory’s upper limit of normal;
16.Known or suspected immunodeficiency or human immunodeficiency virus positivity;
17.Known active or untreated tuberculosis;
18.Known infection with hepatitis B or C;
19.Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
20.History of drug or alcohol dependence;
21.History of serious drug or iodine allergy or sensitivity;
22.Previous receipt of CF101;
23.History of malignancy within the past 5 years (excluding basal cell carcinoma of the skin and =3 cutaneous squamous cell carcinomas, all of which have been completely excised);
24.Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient’s ability to complete the study, and/or compromise the objectives of the study;
25.Participation in another investigational drug or vaccine trial concurrently or within 30 days; or within 5 half lives of a biological investigational product, whichever is longer;
26.Other conditions which would confound the study evaluations or endanger the safety of the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •Evaluate the activity of oral CF101 when administered at 1 mg, 2 mg, or 4 mg twice daily for 12 weeks, compared with placebo, in patients with plaque psoriasis; and<br>•Evaluate the safety of oral CF101 in this patient population<br>;Secondary Objective: •Explore the relationship between peripheral blood mononuclear cell (PBMC) adenosine 3 receptor (A3AR) expression level at baseline and response to therapy;Primary end point(s): The activity endpoints to be analyzed for exploring efficacy and planning subsequent trials are: Change from Baseline (CFB) in PASI Score, Precent Change from Baseline (PCFB) in PASI Score, PASI 50, and PASI 75. These parameters will be calculated at Week 2, 4, 8, and 12.<br>Safety endpoints include treatment-emergent adverse events (AEs) and changes in vital signs, physical examination, clinical laboratory tests (liver, kidney, hematology, chemistry and urinalysis), and ECG findings.