A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Wenda Pharma Technology LTD.

About this trial

The purpose of the study is to evaluate the experimental medication WD-890 compared to placebo in participants with moderate-to-severe plaque psoriasis.

Eligibility criteria

Qualifiers

Male or female participant aged 18 to 75 years(inclusive)at the time of informed consent.

Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.

Body surface area (BSA) ≥10%, Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization

Disqualifiers

Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)

Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted

Class III or IV congestive heart failure by New York Heart Association Criteria

Trial design

Treatments tested in this trial

  • Drug:WD-890
  • Drug: placebo

Treatment groups

375 Participants
are divided into 2 treatment groups