Actively Recruiting
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Trial to Evaluate the Efficacy and Safety of D-2570 for Moderate to Severe Plaque Psoriasis
Led by InventisBio Co., Ltd · Updated on 2026-04-29
477
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a drug called D-2570 for adults with moderate to severe plaque psoriasis. This randomized, double-blind, placebo- and active-controlled clinical trial is conducted across multiple centers and includes patients aged 18 to 70 years. The study aims to compare different doses of D-2570 with placebo and another drug, BMS-986165, to understand how well D-2570 works and its safety profile. Participants will receive different doses of D-2570, BMS-986165, or a placebo tablet. The treatment period lasts 16 weeks after enrollment. Throughout the study, both participants and investigators remain unaware of which treatment is given to ensure unbiased results. Blood samples will be collected at scheduled times for pharmacokinetic and pharmacodynamic analysis to monitor how the drug behaves in the body. During the study, participants will attend regular visits for safety and efficacy assessments, including physical exams and laboratory tests such as blood chemistry and urinalysis. The main outcome measured is the treatment's impact on plaque psoriasis over 16 weeks, with safety monitored through an average of 28 weeks until study completion. Participants will also have a safety follow-up after treatment ends to support ongoing monitoring throughout the study duration.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and provides written informed consent
- Age between 18 and 70 years at time of consent, any gender
- Diagnosed with plaque psoriasis suitable for systemic therapy with stable condition for at least 6 months
- At screening and Day 1, Psoriasis Body Surface Area (BSA) ≥10%, Physician Global Assessment (PGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12
- Hematology, blood chemistry, and urinalysis tests are basically normal
- Male and female subjects of childbearing potential agree to abstain from sex or use effective contraception from consent until 30 days after last study drug dose
You will not qualify if you...
- Has any type of psoriasis other than plaque psoriasis, including erythrodermic, pustular, guttate, inverse, or drug-induced psoriasis
- Has other skin lesions like eczema that may interfere with treatment assessment
- History of severe herpes zoster or simplex infection
- History or presence of active, latent, or suspected tuberculosis
- Language barriers or inability/unwillingness to understand and cooperate
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive study medication to evaluate the efficacy and safety of D-2570 in treating moderate to severe plaque psoriasis.
Visits on Day 1, Day 15, Day 29, Day 57, Day 85, and Day 113
Duration - Up to 12 weeks after treatment
Participants are monitored for safety and physical health after treatment completion.
Approximately 6 visits during follow-up
Trial Site Locations
Total: 1 location
1
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China, 200443
Actively Recruiting
Research Team
B
Bingxin Xue
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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