Status:
COMPLETED
Safety and Efficacy Study of CF101 to Treat Psoriasis
Lead Sponsor:
Can-Fite BioPharma
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will test the hypothesis that CF101, which is under development to treat other immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of chronic plaque psori...
Detailed Description
This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of moderate-to-severe chr...
Eligibility Criteria
Inclusion
- Male or female, 18 to 70 years of age, inclusive;
- Diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10%, as judged by the Investigator;
- Duration of psoriasis of at least 6 months;
- PASI score ≥10;
- Body weight ≤100 kg;
- Candidate for systemic treatment or phototherapy for psoriasis;
- ECG is normal or shows abnormalities which, in the judgment of the Investigator, are not clinically significant;
- Females of child-bearing potential must have a negative serum pregnancy test at screening;
- Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
- Ability to complete the study in compliance with the protocol; and
- Ability to understand and provide written informed consent.
Exclusion
- Erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis;
- Treatment with systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks of the Baseline visit;
- Treatment with high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit;
- Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
- Treatment with a biological agent (including etanercept, adalimumab, efalizumab, infliximab, or alefacept) within a period of time equal to 5 times its circulating half-life, or 30 days, whichever is longer, prior to the Baseline visit;
- History of poor clinical response to methotrexate after an adequate regimen and duration of treatment;
- Treatment with systemic nonsteroidal anti-inflammatory drugs, beta-blockers, lithium, hydroxychloroquine, chloroquine, or systemic terbinafine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period;
- Presence or history of uncontrolled asthma;
- Presence or history of uncontrolled arterial hypertension or symptomatic hypotension;
- Significant cardiac arrhythmia or conduction block, congestive heart failure (New York Heart Association Class 3-4), or any other evidence of clinically significant heart disease or clinically significant findings on screening electrocardiogram;
- Hemoglobin level \<9.0 gm/L;
- Platelet count \<125,000/mm\^3;
- White blood cell count \<3500/mm\^3;
- Serum creatinine level greater than 1.5 times the laboratory's upper limit of normal;
- Liver aminotransferase levels greater than 2 times the laboratory's upper limit of normal;
- Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
- History of malignancy within the past 5 years (excluding basal cell carcinoma of the skin and ≤3 cutaneous squamous cell carcinomas, all of which have been completely excised);
- Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study;
- Participation in another investigational drug or vaccine trial concurrently or within 30 days; or within 5 half lives of a biological investigational product, whichever is longer;
- Other conditions which would confound the study evaluations or endanger the safety of the patient.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00428974
Start Date
June 1 2007
End Date
September 1 2009
Last Update
February 8 2023
Active Locations (4)
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1
Haemek Medical Center
Afula, Israel
2
Wolfson Medical Center
Holon, Israel
3
Rabin Medical Center
Petah Tikva, Israel
4
Sheba Medical Center
Tel Litwinsky, Israel