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

NCT ID: NCT06278350

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-11-01

Brief Summary

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

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

D-2570 group 1

D-2570 group 1

Group Type: EXPERIMENTAL

D-2570

Intervention Type: DRUG

Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group

1, group 2, group 3 or placebo group.

D-2570 group 2

D-2570 group 2

Group Type: EXPERIMENTAL

D-2570

Intervention Type: DRUG

Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group

1, group 2, group 3 or placebo group.

D-2570 group 3

D-2570 group 3

Group Type: EXPERIMENTAL

D-2570

Intervention Type: DRUG

Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group

1, group 2, group 3 or placebo group.

Placebo group

Placebo group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group

1, group 2, group 3 or placebo group.

Interventions

D-2570

Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group

1, group 2, group 3 or placebo group.

Intervention Type: DRUG

Placebo

Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group

1, group 2, group 3 or placebo group.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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;

2. 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;

3. 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;

4. Hematology, Blood chemistry and Urinalysis examination were basically normal.

Exclusion Criteria

1. Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;

2. Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;

3. History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;

4. Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;

5. Other conditions that the investigator considers inappropriate for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InventisBio Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianzhong Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Other Identifiers

D2570-201

Identifier Type: -

Identifier Source: org_study_id