A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis (D2570-204)

April 21, 2026 updated by: InventisBio Co., Ltd

Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Experimental: 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.
Drug: 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.
Placebo Comparator: 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.
Drug: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving ACR20 at Week 12 of treatment.
Time Frame: Week 12
Definition of ACR20：The number of tender joints and swollen joints both decreased by at least 20% compared with the baseline.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects achieving minimal disease activity at Week 12 of treatment;
Time Frame: Week 12
Week 12
Proportion of subjects achieving very low disease activity at Week 12 of treatment;
Time Frame: Week 12
Week 12
Plasma concentrations of D-2570
Time Frame: 0-week 24
0-week 24
safety（AEs）
Time Frame: 0-week 24
An Adverse Event (AE) is definedas any new untoward medicaloccurrence or worsening of a preexistingmedical condition in a clinicalinvestigation participant administeredstudy treatment and that does notnecessarily have a causal relationshipwith this treatment.
0-week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InventisBio Co., Ltd

Investigators

  • Principal Investigator: yi liu, phD, West China School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

August 6, 2028

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2570-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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