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

A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis

This trial tests whether the oral medicine D-2570 helps adults with moderate to severe plaque psoriasis compared with placebo and an approved oral drug.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 477 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: InventisBio Co., Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07326813 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 to 70 with plaque psoriasis suitable for systemic therapy, stable for at least 6 months, and meeting BSA ≥10%, PGA ≥3, and PASI ≥12 with essentially normal lab tests are the intended candidates.

Not a fit: People with mild psoriasis (below the BSA/PASI/PGA thresholds), unstable disease, serious lab abnormalities, pregnancy, or those outside the age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, D-2570 could provide another effective oral option to clear skin and reduce symptoms for people with moderate to severe plaque psoriasis.

How similar studies have performed: Oral TYK2 inhibition with BMS-986165 (deucravacitinib) has produced positive Phase 3 results and regulatory approval, so the active-control approach has precedent while D-2570 itself remains under testing.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Shanghai Skin Disease Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Bingxin Xue

Conditions Plaque Psoriasis