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

NCT07130604 | Recruiting Phase 3

• 1 other identifier: D2570-301
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects with at least 90% improvement in PASI

  The percentage of subjects with at least 90% improvement in PASI from baseline at week 16 of treatment.

  Day 1-Day 112

Secondary Outcomes (20)

• Percentage of subjects with a PGA

  Day 1-Day 112

• The percentage of subjects with at least 75% improvement in PASI

  Day1-Day365

• The percentage of subjects with at least 90% improvement in PASI

  Day1-Day365

• The percentage of subjects with at least 100% improvement in PASI

  Day1-Day365

• The percentage of subjects with improvement in PASI

  Day1-Day365

Study Arms (3)

D-2570 group1

EXPERIMENTAL

Drug: D-2570

D-2570 group2

EXPERIMENTAL

Drug: D-2570

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

D-2570 DRUG

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

D-2570 group1; D-2570 group2

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Study Officials

• Jianzhong Zhang

  Study Official is required by the WHO and ICMJE.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Tang

CONTACT

021-50663661; nan.tang@inventisbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): July 28, 2027
• Study Completion (Estimated): July 28, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)