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

NCT06912165 | Recruiting Phase 2

• 1 other identifier: WENDA890PSO-001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Brief Description of Focus of Study

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16

  Screening up to Week 16

Study Arms (4)

Group 1: WD-890 Dose 1 QD and Placebo

EXPERIMENTAL

Drug: WD-890 tablet

Group 2: WD-890 Dose 2 QD and Placebo

EXPERIMENTAL

Drug: WD-890 tablet

Group 3: WD-890 Dose 3 QD and Placebo

EXPERIMENTAL

Drug: WD-890 tablet

Group 4: Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

WD-890 tablet 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 1: WD-890 Dose 1 QD and Placebo

Placebo DRUG

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

Group 4: Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zhejiang Wenda Pharma Technology LTD.: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210000, China

RECRUITING

Central Study Contacts

Qianjin Lu, doctor

CONTACT

+86 137 8709 7676; qianlu5860@pumcderm.cams.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: December 31, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-03

Locations

CN (1)