Moderate-to-Severe Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Sponsors
Can-Fite BioPharma, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. 9. Male subjects must refrain from sperm donation during treatment and until at least 90 days after the end of study drug dosing. Male subjects with fertile or pregnant partners must agree to use condoms throughout the course of the trial and for 3 months after. 10. Ability to complete the study in compliance with the protocol; and 11. Ability to understand and provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 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 (Class I-III in US, Class III-IV in Europe), Vitamin D analogs, keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles) within 2 weeks of the Baseline visit; 6. Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period; 7. Treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the Baseline visit, or anticipated need for such drugs during the study period, unless dose has been stable for 3 months prior to the Screening visit and will remain stable throughout the trial; 8. Serum creatinine level greater than 1.25 times the laboratory's upper limit of normal at Screening; 9. Liver aminotransferase levels greater than 1.5 times the laboratory's upper limit of normal at Screening; 10. QTcF interval on Screening Visit ECG or on average of triplicate Baseline Visit ECGs >450 milliseconds (msec) for males or > 470 msec for females (except when QT prolongation is associated with right or left bundle branch block, in which case enrollment is allowed); 11. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome; 12. Heart disease which is, in the Investigator's judgment, clinically unstable; 13. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes (Appendix 7); 14. Active gastrointestinal disease which could interfere with the absorption of oral medication; 15. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator; 16. Active drug or alcohol dependence; 17. History of depression or suicidal ideation within the past year; 18. Concomitant use of strong cytochrome P450 inducers, e.g., rifampin, phenobarbital, phenytoin, carbamazepine; 19. Previous participation in a piclidenoson (CF101) clinical trial, defined as having received at least one dose of study medication; 20. Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study; 21. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg twice daily (BID) in patients with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of =75% (PASI 75) at Week 16 (superiority); and • Evaluate the safety of oral piclidenoson in this patient population.;Secondary Objective: • Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with placebo, as determined by the proportion of subjects who achieve, respectively, PASI 50, Physician Global Assessment (PGA) score of 0 or 1, and improvement on the Psoriasis Disability Index (PDI) at Week 16 (superiority) • Evaluate the efficacy of oral piclidenoson 2 mg or 3 mg BID, compared with apremilast, as determined by the proportion of subjects who achieve PASI 75, PGA score of 0 or 1, PASI 50 (non-inferiority), and improvement in PDI at Weeks 16 and 32; • Establish assay sensitivity within this trial by comparing the efficacy of apremilast 30 mg BID with that of placebo tablets BID, as determined by the proportion of subjects who achieve PASI 75, PGA score of 0 or 1, PASI 50, and improvement in PDI at Week 16(superiority); ;Primary end point(s): •Proportion of subjects achieving PASI 75;Timepoint(s) of evaluation of this end point: •Endpoint evaluated at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Proportion of subjects achieving PASI 75 Week 32 and PASI 50 at Weeks 16 and 32 •Proportion of subjects achieving PGA of 0 or 1 at Weeks 16 and 32 • Change From Baseline (CFB) in PDI at Weeks 16 and 32;Timepoint(s) of evaluation of this end point: •Endpoint evaluated at Week 32 - Proportion of subjects achieving PASI 75 •Endpoint evaluated at at Weeks 16 and 32 - Proportion of subjects achieving PASI 50 •Endpoint evaluated at Weeks 16 and 32 - Proportion of subjects achieving PGA of 0 or 1 •Endpoint evaluated at at Weeks 16 and 32 - Change From Baseline (CFB) in PDI | — |
Countries
Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Israel, Moldova, Republic of, Poland, Romania, Serbia
Contacts
Public ContactDirector Clinical Operations
CanFite BioPharma Ltd.
Outcome results
None listed