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NCT Number: NCT07315061

A 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.

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Key information

Conditions

PsA (Psoriatic Arthritis) Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China School of Medicine

Chengdu, Sichuan, 610041, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Males and females, 18 to 70 years of age, inclusive at the time of signing of ICF;
  • Have had an psoriatic arthritis of ≥ 3 months in duration prior to signing of ICF;
  • 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

  • History of infection as defined in the protocol;
  • Any of the medical diseases or disorders listed in the protocol;
  • Significant, uncontrolled or unstable disease in any organ.

Treatment and study plan

D-2570

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of subjects achieving minimal disease activity at Week 12 of treatment;

    Time frame: Week 12

  2. Proportion of subjects achieving very low disease activity at Week 12 of treatment;

    Time frame: Week 12

  3. Plasma concentrations of D-2570

    Time frame: 0-week 24

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

chen zhong ma

CONTACT

[email protected]

13401466347

yi liu, Dr.

CONTACT

[email protected]

13401466347

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

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

Acronym: D2570-204

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 2, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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