A Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study of the efficacy and Safety of Daily Piclidenoson (CF101) Administered Orally in Patients with Moderate-to-Severe Plaque Psoriasis

Can-Fite BioPharma, Ltd.0 sites525 target enrollmentFebruary 20, 2019

Overview

No summary available.

Registry

who.int

Start Date

February 20, 2019

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female, 18 to 80 years of age, inclusive;
•2\. Diagnosis of moderate\-to\-severe chronic plaque\-type psoriasis with BSA involvement
•\=10%, as judged by the Investigator;
•3\. PASI score \=12 (Appendix 3\);
•4\. Static PGA \=3 (Appendix 2\);
•5\. Candidate for systemic treatment or phototherapy for psoriasis;
•6\. Duration of psoriasis of at least 6 months;
•7\. Females of childbearing potential must have a negative serum pregnancy test at screening;
•8\. Female subjects of childbearing potential must use highly effective contraception throughout the course of the trial and for 3 months after. Highly effective methods include hormonal contraception (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants; each method must be used with a barrier method, preferably male condom), intrauterine device or system, tubal ligation, partner vasectomy, or dual (male plus female) barrier methods (each barrier method must be used with a hormonal method).
•Female subjects who use a hormonally based method must agree to use it in conjunction with a barrier method. Female partners of male study subjects should consider using one of the above methods of contraception as well. Post\-menopausal status is defined as menopause for at least 1 year prior to the Screening Visit and must be confirmed by an elevated serum FSH level.

•1\. Psoriasis limited to erythrodermic, guttate, palmar, plantar, or
•generalized pustular psoriasis in the absence of plaque psoriasis;
•2\. Prior treatment with apremilast within 4 weeks prior to the Baseline
•visit, or contraindication to apremilast;
•3\. Treatment with systemic retinoids, corticosteroids, tofacitinib, or
•immunosuppressive agents (e.g., methotrexate, cyclosporine) within 4
•weeks of the Baseline visit;
•4\. Treatment with a biological agent (etanercept, adalimumab,
•efalizumab, infliximab, ustekinumab, alefacept, secukinumab, or others, including investigational agents) within a period of time equal to 5 times its circulating half\-life, or 30 days, whichever is longer, prior to the Baseline visit;
•5\. Treatment with high potency topical dermatological corticosteroids