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

Zhejiang Wenda Pharma Technology LTD.

Status and phase: Enrolling; Phase 3

Conditions: Moderate to Severe Plaque Psoriasis

Treatments: Drug: Drug:WD-890; Drug: Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07672561

WENDA890PSO-003

Details and patient eligibility

About

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

Enrollment: 375 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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375 participants in 2 patient groups, including a placebo group

Group 1:WD-890

Experimental group

Description:

Drug:WD-890 WD-890 tablet will be administered orally.

Treatment:

Drug: Drug:WD-890

Group 2: Placebo

Placebo Comparator group

Description:

Drug: Placebo Placebo tablet will be administered orally.

Treatment:

Drug: Drug: placebo