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

Phase 1

• Conditions: Moderate-to-Severe Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-000214-27-PL
• Lead Sponsor: Can-Fite BioPharma, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 525

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified