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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Contact
Study Contact
- Name: Lu Qianjin
- Phone Number: +8613787097676
- Email: qianlu5860@gmail.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210042
- Recruiting
- Hospital of Dermatology, Chinese Academy of Medical Sciences
-
Contact:
- Lu Qianjin
- Phone Number: +8613787097676
- Email: qianlu5860@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Group 1:WD-890
Drug:WD-890 WD-890 tablet will be administered orally. |
WD-890 tablet will be administered orally.
|
|
Placebo Comparator: Group 2: Placebo
Drug: Placebo Placebo tablet will be administered orally. |
Placebo tablet will be administered orally.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
Time Frame: Screening up to Week 16
|
Screening up to Week 16
|
|
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
|
Screening up to Week 16
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome 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.
Time Frame: Screening up to Week 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.
Time Frame: Screening up to Week 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.
Time Frame: Screening up to Week 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.
Time Frame: Screening up to Week 52
|
Screening up to Week 52
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- WENDA890PSO-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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