A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Daily Piclidenoson (CF101) Administered Orally in Subjects with Moderate-to-Severe Plaque Psoriasis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Can-Fite Biopharma Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]

Trial duration

18 Aug 2025 → ongoing

Decision date (initial)

2025-06-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Can-Fite BioPharma

External identifiers

EU CT number

2024-519919-34-00

ClinicalTrials.gov

NCT06643260

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

The co-primary efficacy objectives of this study for all subjects (Segments 1 and 2) are to:
• Evaluate the efficacy of oral piclidenoson 3 mg twice daily (BID) in subjects with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response at Week 16 of ≥75% (PASI 75); and
• Evaluate the efficacy of oral piclidenoson 3 mg BID in subjects with moderate-to-severe plaque psoriasis, compared with placebo, as determined by the proportion of subjects who achieve a Static Physician's Global Assessment (sPGA) at Week 16 of 0 or 1 with at least a 2-point improvement from Baseline.
The primary safety objective of this study for all subjects (Segments 1 and 2) is to:
• Evaluate the safety of oral piclidenoson in this population.

Secondary objectives 2

1. • Evaluate the efficacy at Week 16 of oral piclidenoson 3 mg BID, compared with placebo, as determined by the proportion of subjects (Segments 1 and 2) who achieve, respectively: o Both PASI 75 and sPGA of 0 or 1 with at least a 2-point improvement from Baseline; o Improvement of the Psoriasis Symptoms and Signs Diary (PSSD) to a score of 0 or 1; and o Improvement of the Dermatology Life Quality Index (DLQI) to a score of 0 or 1.
2. • Determine pharmacokinetics (PK) of piclidenoson under the circumstances of this trial using sparse sampling (Segment 2 only).

Conditions and MedDRA coding

Plaque psoriasis

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Male or female, 18 years and above
2. Diagnosis of moderate-to-severe chronic plaque-type psoriasis with BSA involvement ≥10%
3. PASI score ≥12 at the Screening and Baseline visits
4. Static PGA ≥3 at the Screening and Baseline visits
5. Candidate for systemic treatment or phototherapy for psoriasis
6. Duration of psoriasis of at least 12 months
7. Females of childbearing potential must have a negative serum pregnancy test at screening
8. 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
9. 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
10. Ability to complete the study in compliance with the protocol
11. Ability to understand and provide written informed consent

Exclusion criteria 20

1. Psoriasis limited to erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis in the absence of plaque psoriasis
2. 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
3. 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
4. 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
5. Ultraviolet or Dead Sea therapy within 4 weeks of the Baseline visit, or anticipated need for either of these therapies during the study period
6. 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
7. 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)
8. Liver aminotransferase levels greater than 1.5 times the laboratory’s upper limit of normal at Screening
9. 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)
10. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome
11. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes
12. Active gastrointestinal disease which could interfere with the absorption of oral medication
13. Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the Investigator
14. Active drug or alcohol dependence
15. Concomitant use of strong cytochrome P450 inducers, e.g., rifampin, phenobarbital, phenytoin, carbamazepine
16. PHQ-9 score ˃ 4 at baseline
17. 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
18. Previous participation in a piclidenoson (CF101) clinical trial
19. 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
20. Participation in another investigational drug or vaccine trial concurrently or within 30 days prior to the Screening visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 15

1. Proportion of subjects achieving PASI 75
2. Proportion of subjects achieving sPGA of 0 or 1 with at least a 2- point improvement from Baseline
3. Proportion of subjects achieving PASI 50, PASI 90, or PASI 100
4. Proportion of subjects achieving both PASI 75 and sPGA of 0 or 1 with at least a 2-point improvement from Baseline
5. Change from Baseline and Percent Change from Baseline in PASI score
6. Proportion of subjects achieving PSSD of 0 or 1
7. Proportion of subjects achieving DLQI of 0 or 1
8. Change from Baseline in percentage of BSA involved
9. Change from Baseline in PSSD
10. Change from Baseline in DLQI
11. For Segment 2 only: Percentage Change from Baseline in PSSI
12. For Segment 2 only: Percentage Change from Baseline in NAPSI
13. For Segment 2 only: Time to psoriasis relapse during the placebo-controlled withdrawal period
14. For Segment 2 only: Proportion of subjects who experience a psoriasis relapse during the placebo-controlled withdrawal period
15. For Segment 2 only: Proportion of subjects who experience a psoriasis relapse and subsequently achieve PASI 75 during retreatment with piclidenoson

Secondary endpoints 3

1. 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
2. Proportion of subjects who achieve improvement of the PSSD to a score of 0 or 1 at Week 16
3. Proportion of subjects who achieve improvement of the DLQI to a score of 0 or 1 at Week 16

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Can-Fite Biopharma Ltd.

Sponsor organisation

Can-Fite Biopharma Ltd.

Address

Kiryat Matalon, 10, Bareket 10, Bareket

City

Petakh Tikva

Postcode

4951778

Country

Israel

Scientific contact point

Organisation

Can-Fite Biopharma Ltd.

Contact name

Zivit Harpaz

Public contact point

Organisation

Can-Fite Biopharma Ltd.

Contact name

Zivit Harpaz

Third parties 6

Locations

3 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 49 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications