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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519919-34-00
Acronym
CF101-302PS
Enrollment
248
Registered
2025-06-16
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque psoriasis

Brief summary

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

Detailed description

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

Interventions

DRUGMatching Placebo for Piclidenoson

Sponsors

Can-Fite Biopharma Ltd.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of subjects achieving PASI 75, Proportion of subjects achieving sPGA of 0 or 1 with at least a 2- point improvement from Baseline, Proportion of subjects achieving PASI 50, PASI 90, or PASI 100, Proportion of subjects achieving both PASI 75 and sPGA of 0 or 1 with at least a 2-point improvement from Baseline, Change from Baseline and Percent Change from Baseline in PASI score, Proportion of subjects achieving PSSD of 0 or 1, Proportion of subjects achieving DLQI of 0 or 1, Change from Baseline in percentage of BSA involved, Change from Baseline in PSSD, Change from Baseline in DLQI, For Segment 2 only: Percentage Change from Baseline in PSSI, For Segment 2 only: Percentage Change from Baseline in NAPSI, For Segment 2 only: Time to psoriasis relapse during the placebo-controlled withdrawal period, For Segment 2 only: Proportion of subjects who experience a psoriasis relapse during the placebo-controlled withdrawal period, For Segment 2 only: Proportion of subjects who experie

Secondary

MeasureTime frame
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, Proportion of subjects who achieve improvement of the PSSD to a score of 0 or 1 at Week 16, Proportion of subjects who achieve improvement of the DLQI to a score of 0 or 1 at Week 16

Countries

Bulgaria, Greece, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026