Status:
RECRUITING
A Study of WD-890 in Participants With Moderate-to-Severe Plaque Psoriasis
Lead Sponsor:
Zhejiang Wenda Pharma Technology LTD.
Conditions:
Brief Description of Focus of Study
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06912165
Start Date
December 31 2024
End Date
November 30 2025
Last Update
April 11 2025
Active Locations (1)
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1
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Nanjing, Jiangsu, China, 210000