A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy

This is a multicenter, randomized, double-blind, placebo-controlled study in adult males and females, aged 18 years and above, with a diagnosis of moderate-to-severe chronic plaque psoriasis.

This trial will be conducted in 2 sequential Segments. When the required number of subjects have completed Segment 1, enrollment will be paused to perform an interim analysis for futility. If futility is not declared, enrollment in Segment 2 will commence. No subject will participate in both Segment 1 and Segment 2.

For subjects in Segment 1, the design is as follows:

At the Screening Visit (Visit 1, performed within 4 weeks prior to randomization), subjects who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination (including height, weight, sitting blood pressure, respiratory rate, pulse rate and temperature), ECG, Patient Health Questionnaire-9 (PHQ-9), Columbia Suicide Severity Rating Scale (C-SSRS), and assessment of psoriasis (including Psoriasis Area and Severity Index (PASI), Static Physician's Global Assessment (sPGA), Body Surface Area (BSA) involved, Psoriasis Symptoms and Signs Diary (PSSD), and Dermatology Life Quality Index (DLQI)), and clinical laboratory tests.

For subjects enrolled in Segment 2, the design is as follows:

At the Screening Visit (Visit 1, performed within 4 weeks prior to randomization), subjects who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination (including height, weight, sitting blood pressure, respiratory rate, pulse rate and temperature), ECG, PHQ-9, C-SSRS, and assessment of psoriasis \[including PASI score, sPGA, BSA involved, PSSD, DLQI, Psoriasis Scalp Severity Index (PSSI) (for subjects with scalp involvement), and Nail Psoriasis Severity Index (NAPSI) (for subjects with nail involvement)\], and clinical laboratory tests.

The trial for Segment 2 subjects will be conducted in 3 Periods: Period A (Primary Efficacy Period, Weeks 0-16), Period B (Crossover Period, Weeks 17-32), and Period C (Randomized Withdrawal Period, Weeks 33-52).

For the patients included in Segment 1 of the trial, only Period A (Primary Efficacy Period, Weeks 0-16) will be applicable.

For the patients included in Segment 2 of the trial, all the 3 study periods A, B and C will be applicable.