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NCT Number: NCT06912165

A Study of WD-890 in Participants With 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Nanjing, Jiangsu, 210000, China

Location status: Recruiting

Location contact

Qianjin Lu, doctor

CONTACT

[email protected]

+86 13787097676

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

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

    Time frame: Screening up to Week 16

Study contacts

Contact information is provided by the study sponsor or research team.

Qianjin Lu, doctor

CONTACT

[email protected]

+86 137 8709 7676

Sponsors and collaborators

Lead sponsor

Zhejiang Wenda Pharma Technology LTD.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.