A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

NCT ID: NCT07315061

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-22
• Study Completion Date: 2028-08-06

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The target population is patients with active psoriatic arthritis. A total of 222 subjects are planned to be included.

Detailed Description

The study is divided into three groups, each will include 74 subjects. The primary difference among the three groups lay in the dosage and whether they were placebo groups or not. In other aspects, such as population selection, randomization, blinding and outcome evaluation (safety and efficacy), are consistent among the three groups.

Conditions

PsA (Psoriatic Arthritis)

Study Design

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

Study Groups

D-2570 (experimental arm 1)

Subjects will be randomized in a 1:1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2), or placebo (control arm). They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Group Type: EXPERIMENTAL

D-2570

Intervention Type: DRUG

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

D-2570 (experimental arm 2)

Subjects will be randomized in a 1:1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2), or placebo (control arm). They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks. Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Group Type: EXPERIMENTAL

D-2570

Intervention Type: DRUG

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

placebo

Subjects will be randomized in a 1:1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2), or placebo (control arm). They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks. Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Group Type: PLACEBO_COMPARATOR

D-2570

Intervention Type: DRUG

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Placebo

Intervention Type: DRUG

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Interventions

D-2570

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Intervention Type: DRUG

Placebo

Subjects will then be randomized in a 1:1:1 ratio to D-2570 or placebo . They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.Subjects assigned to the placebo group (control arm) completed a 12-week control treatment period,they will then be randomized in a 1:1 ratio to D-2570 (experimental arm 1), D-2570 (experimental arm 2).They will enter the study treatment period and take the assigned investigational product once daily for 12 consecutive weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects voluntarily take part in the study after being fully informed, sign a written informed consent form (ICF), and agree to follow procedures specified in the study protocol;

2. Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF;

3. Have had an psoriatic arthritis of ≥ 3 months in duration prior to signing of ICF;

4. Have had active arthritis, characterized by at least ≥3 tender joints (68 joint tenderness counts) and ≥3 swollen joints (66 joint swelling counts).

Exclusion Criteria

1. History of infection as defined in the protocol;

2. Any of the medical diseases or disorders listed in the protocol;

3. Significant, uncontrolled or unstable disease in any organ.

• 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

yi liu, phD

Role: PRINCIPAL_INVESTIGATOR

West China School of Medicine

Locations

West China School of Medicine

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

yi liu, Dr.

Role: CONTACT

zhongchen.ma@inventisbio.com

13401466347

chen zhong ma

Role: CONTACT

zhongchen.ma@inventisbio.com

13401466347

Other Identifiers

D2570-204

Identifier Type: -

Identifier Source: org_study_id