D-2570 oral treatment for adults with moderate to severe plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo- and active-controlled Phase 3 trial enrolling adults with moderate to severe plaque psoriasis who meet BSA, PGA, and PASI severity thresholds. Participants are randomly assigned to receive D-2570, the active comparator BMS-986165, or placebo, with investigators and subjects blinded during the treatment period. Blood samples for pharmacokinetic and pharmacodynamic analyses are collected at specified time points and safety and efficacy are monitored at scheduled study visits. All subjects undergo a safety follow-up after completing their assigned treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;
* Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
* The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;
* At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;
* Hematology, Blood chemistry and Urinalysis examination were basically normal;
* Male subjects and female subjects of childbearing potential must agree to abstain from sexual intercourse or adopt effective contraceptive measures from the time of signing the informed consent form (ICF) until 30 days after the last administration of the investigational product.

Exclusion Criteria:

* Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;
* Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;
* A history of severe herpes zoster/simplex infection;
* A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection
* Having language barriers, or being unwilling or unable to fully understand and cooperate;
* Being pregnant or lactating women;
* Other circumstances that the investigator deems unsuitable for the subject to participate in the study.

Where it's running

• Shanghai Skin Disease Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Bingxin Xue
• Email: bingxin.xue@inventisbio.com
• Phone: (86)21-50663661

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.