A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy

NCT06643260 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CF101-302PS
• Study Type: interventional
• Target: 705
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a double-blind, placebo-controlled study in adults with a diagnosis of moderate-to-severe chronic plaque psoriasis to test the efficacy and safety of piclidenoson in this patient population.

Conditions

Plaque Psoriasis

Keywords

Psoriasis; Plaque psoriasis

Outcome Measures

Primary Outcomes (3)

• Proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75)

  Improvement of psoriasis by 75% or more

  16 weeks

• proportion of subjects who achieve a Static Physician's Global Assessment (sPGA) of 0 or 1 with at least a 2-point improvement from Baseline

  Improvement of psoriasis by physicians' judgment

  16 weeks

• Proportion of subjects who experience adverse events

  All adverse events occurring the trial will be recorded

  52 weeks

Secondary Outcomes (3)

• Efficacy as determined by the proportion of subjects who achieve both PASI 75 and sPGA of 0 or 1 with at least a 2-point improvement from Baseline

  16 weeks

• Efficacy as determined by the proportion of subjects who achieve improvement of the Psoriasis Symptoms and Signs Diary (PSSD) to a score of 0 or 1

  16 weeks

• Efficacy as determined by the proportion of subjects who achieve improvement of the Dermatology Life Quality Index (DLQI) to a score of 0 or 1

  16 weeks

Study Arms (2)

Piclidenoson treatment

EXPERIMENTAL

Drug: piclidenoson

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

piclidenoson DRUG

Piclidenoson is a selective A3AR agonist, supplied as tablets.

Piclidenoson treatment

Placebo DRUG

Inactive control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years and above;
• Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%;
• PASI score ≥12 at the Screening and Baseline visits;
• Static PGA ≥3 at the Screening and Baseline visits;
• Candidate for systemic treatment or phototherapy for psoriasis;
• Duration of psoriasis of at least 12 months;
• Females of childbearing potential must have a negative serum pregnancy test at screening;
• Female subjects of childbearing potential must use at least one acceptable contraceptive method throughout the course of the trial and for 1 month after the last dose of study medication;
• 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;
• Ability to complete the study in compliance with the protocol; and
• Ability to understand and provide written informed consent.

You may not qualify if:

• Psoriasis limited to erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis in the absence of plaque psoriasis;
• 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;
• 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;
• 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, trimethyl-psoralens, fumarate, PDE4 inhibitors, or aryl hydrocarbon receptor-modulating agents within 2 weeks of the Baseline visit;
• Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period;
• 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;
• 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);
• Liver aminotransferase levels greater than 1.5 times the laboratory's upper limit of normal at Screening;
• 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);
• A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome;
• Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes;
• Active gastrointestinal disease which could interfere with the absorption of oral medication;
• Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator;
• Active drug or alcohol dependence;
• Concomitant use of strong cytochrome P450 inducers, e.g., rifampin, phenobarbital, phenytoin, carbamazepine;

Sponsors & Collaborators

• Can-Fite BioPharma: lead

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zivit Harpaz

CONTACT

+972 3 924 1114; zivit@canfite.co.il

Pnina Fishman, PhD

CONTACT

+972 3 924 1114; pnina@canfite.co.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial will be conducted in 2 sequential Segments. When the planned number of subjects have completed Segment 1, enrollment will be paused to perform an interim analysis for futility. If futility is not declared, enrollment in Segment 2 will commence. There will be one decision made in this futility analysis that will be conducted by an outside committee. Blinding will remain in full except for a select group of this committee. The committee will decide either to stop the study because of futility, continue the study as is, or continue the study with an increase in sample size. The increase in sample size cannot be greater than 25% of the planned sample size.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 16, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share