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NCT07672561
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
Conditions: Moderate to Severe Plaque Psoriasis
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 375
Sponsor: Zhejiang Wenda Pharma Technology LTD.
Location: Hospital of Dermatology, Chinese Academy of Medical Sciences Nanjing Jiangsu
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 Criteria
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
Source: ClinicalTrials.gov (NCT07672561). StuddyBuddy aggregates publicly available trial information.