Trial of CF101 to Treat Patients With Psoriasis

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Can-Fite BioPharma

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.