Plaque psoriasis
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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