NCT07315061

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for phase_2

Timeline
27mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Aug 2028

First Submitted

Initial submission to the registry

December 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2027

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

December 18, 2025

Last Update Submit

April 21, 2026

Conditions

PsA (Psoriatic Arthritis)

Keywords

PsA (Psoriatic Arthritis)

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects achieving ACR20 at Week 12 of treatment.

    Definition of ACR20：The number of tender joints and swollen joints both decreased by at least 20% compared with the baseline.

    Week 12

Secondary Outcomes (4)

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

    Week 12

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

    Week 12

  • Plasma concentrations of D-2570

    0-week 24

  • safety（AEs）

    0-week 24

Study Arms (3)

D-2570 (experimental arm 1)

EXPERIMENTAL

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

D-2570 (experimental arm 2)

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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-2570Drug: Placebo

Interventions

D-2570DRUG

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 1)D-2570 (experimental arm 2)placebo
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China School of Medicine

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • yi liu, phD

    West China School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

yi liu, Dr.

CONTACT

13401466347zhongchen.ma@inventisbio.com

chen zhong ma

CONTACT

13401466347zhongchen.ma@inventisbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

August 6, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)