Trial of CF101 to Treat Patients With Psoriasis

Can-Fite BioPharma

Status and phase

Completed

Phase 3

Phase 2

Conditions

Plaque Psoriasis

Treatments

Drug: CF101

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01265667

CF101-202PS

Details and patient eligibility

About

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.

Full 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.

Enrollment

293 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.