Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
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
DRUGDrug:WD-890
WD-890 tablet will be administered orally.
DRUGDrug: placebo
Placebo tablet will be administered orally.
Sponsors
Zhejiang Wenda Pharma Technology LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 | Screening up to Week 16 |
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16 | Screening up to Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | 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. | 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. | Screening up to Week 52 |
Countries
China
Contacts
CONTACTLu Qianjin
Outcome results
None listed