RecruitingPhase 3NCT07130604

Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Moderate to Severe Plaque Psoriasis


Sponsor

InventisBio Co., Ltd

Enrollment

390 participants

Start Date

Sep 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, double-blind, placebo-controlled multicenter clinical trial targeting subjects with moderate to severe plaque psoriasis.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;
  • Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;
  • During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;
  • Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion Criteria5

  • Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;
  • Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;
  • History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;
  • Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;
  • Other conditions that the investigator considers inappropriate for participation in the study.

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Interventions

DRUGD-2570

Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.

DRUGPlacebo

Randomized in a 1:1:1 ratio through the randomization system, and assigned to D-2570 group1, group 2 or placebo group.


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07130604


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