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

NCT ID: NCT06912165

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-11-30

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.

Conditions

Brief Description of Focus of Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: WD-890 Dose 1 QD and Placebo

Group Type: EXPERIMENTAL

WD-890 tablet

Intervention Type: DRUG

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.

Group 2: WD-890 Dose 2 QD and Placebo

Group Type: EXPERIMENTAL

WD-890 tablet

Intervention Type: DRUG

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.

Group 3: WD-890 Dose 3 QD and Placebo

Group Type: EXPERIMENTAL

WD-890 tablet

Intervention Type: DRUG

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.

Group 4: Placebo

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive placebo QD from Week 0 through Week 16.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo

Participants will receive placebo QD from Week 0 through Week 16.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Wenda Pharma Technology LTD.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qianjin Lu, doctor

Role: CONTACT

qianlu5860@pumcderm.cams.cn

+86 137 8709 7676

Facility Contacts

Qianjin Lu, doctor

Role: primary

qianlu5860@pumcderm.cams.cn

+86 13787097676

Other Identifiers

WENDA890PSO-001

Identifier Type: -

Identifier Source: org_study_id