PICLIDENOSON for Plaque psoriasis

Inclusion criteria

• {"criterion_text":"- Male or female, 18 years and above\n- Ability to complete the study in compliance with the protocol\n- Ability to understand and provide written informed consent\n- Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%\n- PASI score ≥12 at the Screening and Baseline visits\n- Static PGA ≥3 at the Screening and Baseline visits\n- Candidate for systemic treatment or phototherapy for psoriasis\n- Duration of psoriasis of at least 12 months\n- Females of childbearing potential must have a negative serum pregnancy test at screening\n- Female subjects of childbearing potential must use at least one acceptable contraceptive method (as described in Section 10.7) throughout the course of the trial and for 1 month after the last dose of study medication\n- Male subjects must refrain from sperm donation during treatment and until at least 1 month after the last dose of study medication. Male subjects must agree to use condoms throughout the course of the trial and for 1 month after the last dose of study medication"}

Exclusion criteria

• {"criterion_text":"- Psoriasis limited to erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis in the absence of plaque psoriasis\n- A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome\n- Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes\n- Active gastrointestinal disease which could interfere with the absorption of oral medication\n- Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator\n- Active drug or alcohol dependence\n- Concomitant use of strong cytochrome P450 inducers, e.g., rifampin, phenobarbital, phenytoin, carbamazepine\n- PHQ-9 score ˃ 4 at baseline\n- Any significant/uncontrolled neuropsychiatric illness judged as clinically significant by the investigator during screening or at Day 1, or any lifetime history of suicidal ideation, suicidal behavior, or suicidal attempts by medical history or by Columbia Suicide Severity Rating Scale (C-SSRS) documentation, or by answering “yes” to Question 4 or 5 for suicidal ideation on the C-SSRS at screening or at Day 1, or is clinically deemed to have a suicide risk by the investigator\n- Previous participation in a piclidenoson (CF101) clinical trial\n- 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\n- Treatment with systemic retinoids, systemic corticosteroids, tofacitinib, apremilast, immunosuppressive agents (e.g., methotrexate, cyclosporine), or any other approved drugs for the indication of plaque psoriasis (e.g., deucravacitinib) within 4 weeks of the Baseline visit\n- Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit\n- Treatment with a monoclonal antibody or other biologic agent for psoriasis within 8 weeks for etanercept, adalimumab, or infliximab, or within 12 weeks for all other agents, prior to the Baseline visit\n- Treatment with Vitamin D analogs, keratolytics, coal tar (other than on the scalp, palms, groin, and/or soles), any topical corticosteroid, calcineurin inhibitors, vitamin A analogs, retinoids, anthralin, calcipotriene, tazarotene, methoxsalen, trimethylpsoralens, fumarate, PDE4 inhibitors, or aryl hydrocarbon receptormodulating agents within 2 weeks of the Baseline visit\n- Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period\n- 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\n- Estimated glomerular filtration rate (eGFR) <50 mL/min/1.73m2 by the Modification of Diet in Renal Disease equation at Screening (NOTE: In Segment 2, a renally-impaired subgroup of at least 10-12 subjects with eGFR of 20-49 mL/min/1.73m2 will be enrolled for PK analysis purposes)\n- Liver aminotransferase levels greater than 1.5 times the laboratory’s upper limit of normal at Screening\n- QTcF interval > 450 milliseconds (msec) for males or > 470 msec for females on Screening Visit and Baseline visit ECGs (average of triplicate ECGs at each visit) (except when QT prolongation is associated with right or left bundle branch block or cardiac pacemaker, in which case enrollment is allowed)"}

Primary endpoints

• {"endpoint_text":"- Proportion of subjects achieving PASI 75","definition_or_measurement_approach":"PASI 75 measured at Week 16 (co-primary efficacy objective for Segments 1 and 2 comparing piclidenoson 3 mg BID vs placebo)."}
• {"endpoint_text":"- Proportion of subjects achieving sPGA of 0 or 1 with at least a 2- point improvement from Baseline","definition_or_measurement_approach":"sPGA measured at Week 16; co-primary efficacy objective requiring sPGA 0 or 1 with ≥2-point improvement from Baseline."}
• {"endpoint_text":"- Proportion of subjects achieving PASI 50, PASI 90, or PASI 100","definition_or_measurement_approach":"PASI responses assessed (timepoint consistent with primary assessments, including Week 16)."}
• {"endpoint_text":"- Proportion of subjects achieving both PASI 75 and sPGA of 0 or 1 with at least a 2-point improvement from Baseline","definition_or_measurement_approach":"Composite endpoint assessed at Week 16 (both PASI 75 and sPGA 0/1 with ≥2-point improvement)."}
• {"endpoint_text":"- Change from Baseline and Percent Change from Baseline in PASI score","definition_or_measurement_approach":"Absolute and percent change in PASI from Baseline assessed at scheduled visits (including Week 16)."}
• {"endpoint_text":"- Proportion of subjects achieving PSSD of 0 or 1","definition_or_measurement_approach":"Patient-reported Psoriasis Symptoms and Signs Diary (PSSD) score of 0 or 1 assessed (primary efficacy timepoint Week 16)."}
• {"endpoint_text":"- Proportion of subjects achieving DLQI of 0 or 1","definition_or_measurement_approach":"Dermatology Life Quality Index (DLQI) score of 0 or 1 assessed (primary efficacy timepoint Week 16)."}
• {"endpoint_text":"- Change from Baseline in percentage of BSA involved","definition_or_measurement_approach":"Percent body surface area (BSA) affected change from Baseline assessed at scheduled visits (including Week 16)."}
• {"endpoint_text":"- Change from Baseline in PSSD","definition_or_measurement_approach":"Change in PSSD score from Baseline assessed at scheduled visits (including Week 16)."}
• {"endpoint_text":"- Change from Baseline in DLQI","definition_or_measurement_approach":"Change in DLQI from Baseline assessed at scheduled visits (including Week 16)."}
• {"endpoint_text":"- For Segment 2 only: Percentage Change from Baseline in PSSI","definition_or_measurement_approach":"For Segment 2 subjects with scalp involvement, percent change in Psoriasis Scalp Severity Index (PSSI) from Baseline."}
• {"endpoint_text":"- For Segment 2 only: Percentage Change from Baseline in NAPSI","definition_or_measurement_approach":"For Segment 2 subjects with nail involvement, percent change in Nail Psoriasis Severity Index (NAPSI) from Baseline."}
• {"endpoint_text":"- For Segment 2 only: Time to psoriasis relapse during the placebo-controlled withdrawal period","definition_or_measurement_approach":"Time-to-event during withdrawal period (defined timing and relapse criteria described in protocol; e.g., loss of ≥50% of PASI improvement from Week 32 baseline or sPGA >1)."}
• {"endpoint_text":"- For Segment 2 only: Proportion of subjects who experience a psoriasis relapse during the placebo-controlled withdrawal period","definition_or_measurement_approach":"Proportion experiencing relapse during placebo-controlled withdrawal (relapse defined per protocol: loss of at least 50% of PASI improvement from Week 32 vs Baseline or sPGA >1)."}
• {"endpoint_text":"- For Segment 2 only: Proportion of subjects who experience a psoriasis relapse and subsequently achieve PASI 75 during retreatment with piclidenoson","definition_or_measurement_approach":"Proportion of subjects who relapse during withdrawal and then achieve PASI 75 upon retreatment; assessed during retreatment period (Segment 2)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of subjects who achieve both PASI 75 and sPGA of 0 or 1 with at least a 2-point improvement from Baseline at Week 16","definition_or_measurement_approach":"Composite efficacy endpoint at Week 16 (same as primary composite but listed as secondary in endpoint listing)."}
• {"endpoint_text":"- Proportion of subjects who achieve improvement of the PSSD to a score of 0 or 1 at Week 16","definition_or_measurement_approach":"PSSD improvement to 0 or 1 at Week 16 (patient-reported outcome)."}
• {"endpoint_text":"- Proportion of subjects who achieve improvement of the DLQI to a score of 0 or 1 at Week 16","definition_or_measurement_approach":"DLQI improvement to 0 or 1 at Week 16 (quality-of-life measure)."}

Greece

Earliest CTIS Part Ii Submission Date

11-03-2025

Latest Decision Or Authorization Date

16-06-2025

Processing Time Days

97

Number Of Sites

3

Number Of Participants

37

Poland

Earliest CTIS Part Ii Submission Date

14-10-2025

Latest Decision Or Authorization Date

07-03-2026

Processing Time Days

144

Number Of Sites

7

Number Of Participants

130

Bulgaria

Earliest CTIS Part Ii Submission Date

18-06-2025

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

301

Number Of Sites

3

Number Of Participants

146

Primary sponsor

Full Name

Can-Fite Biopharma Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Israel

Contract research organisations

Name

Icon Clinical Research (U.K.) Limited

Responsibilities

8

Name

Phaze S.A.

Responsibilities

1|11|12|2

Name

Sharp Clinical Services LLC

Responsibilities

14

Name

Medicover Integrated Clinical Services Sp. z o.o.

Responsibilities

4

Third parties

• {"country":"Poland","full_name":"Medicover Integrated Clinical Services Sp. z o.o.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"Phaze S.A.","duties_or_roles":"1|11|12|2","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Palleos Healthcare GmbH","duties_or_roles":"1|10|12|13|2|5|6","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Icon Clinical Research (U.K.) Limited","duties_or_roles":"8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Sharp Clinical Services LLC","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Manufacturing Packaging Farmaca (MPF) B.V.","duties_or_roles":"14","organisation_type":"Pharmaceutical company"}