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: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 407

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. Elevated whole blood A3AR expression level, defined as = 1.5-fold over a predetermined
normal population standard at Screening;
8. Females of child-bearing potential must have a negative serum pregnancy test at screening;
9. 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;
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

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 atScreening;
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;
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