Recent Updates
Recently added Catalysts

piclidenoson

Phase 3

Plaque Psoriasis | Small molecule | Immunology |Can-Fite Biopharma Ltd|Last Updated: Apr 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment705
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06643260A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and EfficacyPHASE3 NOT YET_RECRUITING 705Jun 1, 2025Jun 1, 2028Apr 29, 2025 -
Unlock Drug Trial Details
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

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
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Piclidenoson treatmentEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
piclidenosonDRUGPiclidenoson is a selective A3AR agonist, supplied as tablets.
PlaceboDRUGInactive control
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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...

Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06643260primaryCompletionDate: changed
LOWMay 24, 2026NCT06643260studyFirstPostDate: changed