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

Phase 2

Recruiting

• Conditions: Brief Description of Focus of Study
• Interventions: Drug: WD-890 tablet; Drug: Placebo

• Registration Number: NCT06912165
• Lead Sponsor: Zhejiang Wenda Medical Technology Co., Ltd.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-10-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: WD-890 Dose 1 QD and Placebo	WD-890 tablet	-
Group 2: WD-890 Dose 2 QD and Placebo	WD-890 tablet	-
Group 3: WD-890 Dose 3 QD and Placebo	WD-890 tablet	-
Group 4: Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16	Screening up to Week 16

Trial Locations

Locations (1)

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College; 🇨🇳 Nanjing, Jiangsu, China