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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis

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.

Study Overview

• Status: Recruiting
• Conditions: Brief Description of Focus of Study
• Intervention / Treatment: Drug: WD-890 tablet; Drug: WD-890 tablet; Drug: WD-890 tablet; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qianjin Lu, doctor; Phone Number: +86 137 8709 7676; Email: qianlu5860@pumcderm.cams.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
      • Contact: Qianjin Lu, doctor; Phone Number: +86 13787097676; Email: qianlu5860@pumcderm.cams.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: WD-890 Dose 1 QD and Placebo	Drug: WD-890 tablet; Participants will receive WD-890 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.; Drug: WD-890 tablet; Participants will receive WD-890 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.; Drug: WD-890 tablet; Participants will receive WD-890 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Experimental: Group 2: WD-890 Dose 2 QD and Placebo	Drug: WD-890 tablet; Participants will receive WD-890 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.; Drug: WD-890 tablet; Participants will receive WD-890 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.; Drug: WD-890 tablet; Participants will receive WD-890 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Experimental: Group 3: WD-890 Dose 3 QD and Placebo	Drug: WD-890 tablet; Participants will receive WD-890 Dose 1 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.; Drug: WD-890 tablet; Participants will receive WD-890 Dose 2 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.; Drug: WD-890 tablet; Participants will receive WD-890 Dose 3 QD and placebo from Week 0 through Week 16. Participants will receive placebo to maintain the blinding of dose regimens.
Experimental: Group 4: Placebo	Drug: Placebo; Participants will receive placebo QD from Week 0 through Week 16.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhejiang Wenda Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: WENDA890PSO-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No