Recruiting NCT07672561
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug:WD-890, Drug: placebo.
- Who it may be relevant to
- Registry conditions: Moderate to Severe Plaque Psoriasis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of the study is to evaluate the experimental medication WD-890 compared to placebo in participants with moderate-to-severe plaque psoriasis.
Interventions
- Drug Drug:WD-890
WD-890 tablet will be administered orally. - Drug Drug: placebo
Placebo tablet will be administered orally.
Primary outcome measures
- Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 [Time frame: Screening up to Week 16]
- Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16 [Time frame: Screening up to Week 16]
Secondary outcome measures (4)
- Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52. [Time frame: Screening up to Week 52]
- Percentage of Participants Achieving PASI 90 Score at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52. [Time frame: Screening up to Week 52]
- Percentage of Participants Achieving PASI 100 Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52. [Time frame: Screening up to Week 52]
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52. [Time frame: Screening up to Week 52]
Eligibility criteria
Inclusion criteria
- Male or female participant aged 18 to 75 years(inclusive)at the time of informed consent.
- Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.
- Body surface area (BSA) ≥10%, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Hospital of Dermatology, Chinese Academy of Medical Sciences — Nanjing
Identifiers
NCT: NCT07672561 · WENDA890PSO-003