CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis

• Status: Recruiting
• Trial end date: 2022-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This trial will test the hypothesis that the administration of CF101, a novel anti-inflammatory agent, to patients with moderate to severe plaque psoriasis will relieve signs and symptoms of the disease. CF101 effect will be in comparison to apremilast in this study population

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Can-Fite BioPharma
• Treatments: Apremilast; Thalidomide

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. 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.

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 1.5 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. Electrocardiogram (ECG) at Screening shows abnormalities which, in the judgment of the Investigator, are clinically significant and could, in the judgment of the Principal Investigator, compromise subject safety;

11. Active gastrointestinal disease which could interfere with the absorption of oral medication;

12. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;

13. Active drug or alcohol dependence;

14. History of depression or suicidal ideation within the past year;

15. Concomitant use of strong cytochrome P450 inducers, eg, rifampin, phenobarbital, phenytoin, carbamazepine;

16. Previous participation in a CF101 clinical trial;

17. 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;

18. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit.