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Trial of CF101 to Treat Patients With Psoriasis

Sponsored by Can-Fite BioPharma

Phase Quota
Phase 2

Eligible patients with Psoriasis will be treated with CF101 or placebo twice daily for 12 weeks. After 12 weeks the placebo arm will randomized to active dosages.

Study Start Date: July 2011

Estimated Completion Date: May 2015

Specialties: Dermatology: Clinical Pharmacology,Psoriasis Family Medicine: Dermatology Internal Medicine: Clinical Pharmacology,Dermatology Nurse Practitioner: Dermatology

Interventions

  • Drug: CF101
  • Drug: Placebo

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
  • PGA >=3
  • Candidate for systemic treatment or phototherapy for psoriasis
  • 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

Study Locations And Contact Information

  • DCC Fokus5MIOC EOOD, Sofia,
  • UMHAT Gstranski, Pleven
  • MHAT Varna at MMA Sofia, Varna,
  • Spitalul Clinic Judetean de Urgenta Constanta, Constanta,
  • Centrul Medical Euromed, Bucuresti
  • Multiprofile Hospital for Active Ttreatment, Stara Zagora
  • Military Medical Acdemy MMA, Sofia
  • Centrul Medical Euromed, Bucuresti
  • UMHAT Gstranski, Pleven
  • Spit Clinic Judetean de Urgenta Sf Spiridon Iasi, Iasi
  • County Clinical Emergency Hospital, Sibiu
  • MHAT Doverie, Sofia
  • Emergency County Clinical Hospital, Cluj-Napoca
  • MHAT Doverie, Sofia
  • Spit Clinic Judetean de Urgenta Sf Spiridon Iasi, Iasi
  • Rambam Medical Center, Haifa
  • Spitalul Clinic DermatoVenerice, Bucuresti
  • County Clinical Emergency Hospital, Sibiu
  • Rambam Medical Center, Haifa
  • Haemek Medical Center, Afula
  • Mount Sinai School of Medicine, New York New York
  • City Center for Skin and Venereal Disease, Sofia
  • MHAT Varna at MMA Sofia, Varna,
  • Spitalul Clinic Judetean de Urgenta Constanta, Constanta,
  • MHAT Tokuda hospital Sofia, Sofia,
  • City Center for Skin and Venereal Disease, Sofia
  • Rabin Medical Center, Petah Tiqva
  • Military Medical Acdemy MMA, Sofia
  • Spitalul Clinic DermatoVenerice, Bucuresti
  • Mount Sinai School of Medicine, New York New York
  • MHAT Tokuda hospital Sofia, Sofia,
  • Haemek Medical Center, Afula
  • Multiprofile Hospital for Active Ttreatment, Stara Zagora
  • Rabin Medical Center, Petah Tiqva
  • DCC Fokus5MIOC EOOD, Sofia,
  • Emergency County Clinical Hospital, Cluj-Napoca

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