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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Male or female participant aged 18 to 70 years(inclusive)at the time of willing to sign a consent form. - 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 Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

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.

DRUG

Placebo

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

Locations (1)

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