Evaluating WD-890 for moderate-to-severe plaque psoriasis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis
This study is testing a new treatment called WD-890 to see if it helps people aged 18 to 70 with moderate-to-severe plaque psoriasis feel better over 16 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhejiang Wenda Pharma Technology LTD. Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06912165 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of WD-890 in participants suffering from moderate-to-severe plaque psoriasis over a 16-week treatment period. Participants aged 18 to 70 will be randomized to receive either WD-890 or a placebo, with a total study duration of up to 24 weeks including screening and safety follow-up. The primary focus is to determine the dose response of WD-890 based on the severity of psoriasis as measured by the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (sPGA).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of plaque psoriasis affecting at least 10% of their body surface area.
Not a fit: Patients with nonplaque forms of psoriasis or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with moderate-to-severe plaque psoriasis.
How similar studies have performed: While this approach is not widely tested, similar studies targeting plaque psoriasis have shown promising results with new treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Nanjing, Jiangsu
- Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Qianjin Lu, doctor
- Email: qianlu5860@pumcderm.cams.cn
- Phone: +86 137 8709 7676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.