A Study of WD-890 in Participants With Moderate-to-Severe Plaque Psoriasis

Zhejiang Wenda Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 2

Conditions: Brief Description of Focus of Study

Treatments: Drug: Placebo; Drug: WD-890 tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06912165

WENDA890PSO-001

Details and patient eligibility

About

Th purpose of the study is to evaluate the dose response of WD-890 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

Full description

The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Aged 18 to 70 years (inclusive) were enrolled in this study. Participants were randomized to receive WD-890 or placebo.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participant aged 18 to 70 years(inclusive)at the time of informed consent.

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

  ≥10% of BSA involvement at screening visit and randomization;

• 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
• Participant with a history of chronic bacterial infections (e.g., chronic pyelonephritis, chronic bronchiectasis, or chronic osteomyelitis).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups

Group 1: WD-890 Dose 1 QD and Placebo

Experimental group

Treatment:

Drug: WD-890 tablet

Drug: WD-890 tablet

Drug: WD-890 tablet

Group 2: WD-890 Dose 2 QD and Placebo

Experimental group

Treatment:

Drug: WD-890 tablet

Drug: WD-890 tablet

Drug: WD-890 tablet

Group 3: WD-890 Dose 3 QD and Placebo

Experimental group

Treatment:

Drug: WD-890 tablet

Drug: WD-890 tablet

Drug: WD-890 tablet

Group 4: Placebo

Experimental group

Treatment:

Drug: Placebo