Trial of CF101 to Treat Patients With Psoriasis

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT01265667

Run by

Can-Fite BioPharma

People needed

293

Starts

2011-07-01

Expected to finish

2015-05-01

Last updated by the study team

2020-11-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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