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piclidenoson

Phase 3

Plaque Psoriasis | Small molecule | Dermatology |Can-Fite Biopharma Ltd|Last Updated: Feb 18, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment705
FDA Designations
No designations recorded
Clinical trial landscape

piclidenoson · 3 trials · 4 indications

Phase 3 1Phase 2 2
NCT06643260A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and EfficacyPlaque Psoriasis
NOT YET_RECRUITING705 Analytics
PHASE3NOT YET_RECRUITING
A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy
Plaque Psoriasis
NCT06643260705
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Study Endpoints
Primary Endpoints
Proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75)
16 weeks

Improvement of psoriasis by 75% or more

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
16 weeks

Improvement of psoriasis by physicians' judgment

Proportion of subjects who experience adverse events
52 weeks

All adverse events occurring the trial will be recorded

99mTc-DMSA
6 months

The primary end-point is to assess whether treatment for 6 months with piclidenoson improves the functioning of renal proximal tubular cells (PTCs), as assessed by the increase in 99mTc-DMSA uptake as compared to Baseline

Proportion of subjects alive and free of respiratory failure
29 days

Proportion of subjects alive and free of respiratory failure (defined as need for non-invasive or invasive mechanical ventilation, high-flow oxygen, or extracorporeal membrane oxygenation) at Day 29

Proportion of subjects discharged home alive
29 days

Proportion of subjects alive and discharged to home without need for supplemental oxygen at Day 29

Treatment-emergent adverse events (AEs)
29 days

Proportion of patients experiencing AEs

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Piclidenoson treatmentEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Piclidenoson (CF101) open-label treated patientsEXPERIMENTALPiclidenoson will be administered orally at a dose of 3 mg twice per day for 6 months
PiclidenosonEXPERIMENTALPiclidenoson 2 mg every 12 hours orally added to standard of care
Interventions
NameTypeDescription
piclidenosonDRUGPiclidenoson is a selective A3AR agonist, supplied as tablets.
PlaceboDRUGInactive control
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 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 o...

Countries:ItalyBulgariaIsraelRomania
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06643260primaryCompletionDate: changed
LOWMay 26, 2026NCT07410455primaryCompletionDate: changed
LOWMay 24, 2026NCT06643260studyFirstPostDate: changed
LOWMay 24, 2026NCT07410455studyFirstPostDate: changed