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
Drug:WD-890: WD-890 tablet will be administered orally.
Drug: placebo: Placebo tablet will be administered orally.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 — Screening up to Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16 — Screening up to Week 16
Trial sites (1)
Facility
City
Region
Status
Hospital of Dermatology, Chinese Academy of Medical Sciences
Nanjing
Jiangsu
Recruiting
More Zhejiang Wenda Pharma Technology LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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