Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT03168256
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03168256
Study Brief:
Protocol Section:
NCT03168256