Brief Description of Focus of Study
Conditions
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.
Detailed description
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.
Interventions
DRUGWD-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.
DRUGPlacebo
Participants will receive placebo QD from Week 0 through Week 16.
Sponsors
Zhejiang Wenda Pharma Technology LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16 | Screening up to Week 16 |
Countries
China
Contacts
Primary ContactQianjin Lu, doctor
Outcome results
None listed