Status:
COMPLETED
Trial of CF101 to Treat Patients With Psoriasis
Lead Sponsor:
Can-Fite BioPharma
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed 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. Approximat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT01265667
Start Date
July 1 2011
End Date
May 1 2015
Last Update
November 18 2020
Active Locations (18)
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1
Mount Sinai School of Medicine
New York, New York, United States
2
UMHAT "G.stranski"
Pleven, Bulgaria, 5800,
3
MHAT "Tokuda hospital Sofia"
Sofia, Bulgaria, 1407
4
DCC "Fokus-5"-MIOC, EOOD
Sofia, Bulgaria, 1463