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PsA (Psoriatic Arthritis)Phase 2D2570-204NCT07315061

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

A Phase 2 study testing D-2570 in people with PsA (Psoriatic Arthritis), run by InventisBio Co., Ltd at 1 site in China.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
PsA (Psoriatic Arthritis)
What is being tested?
D-2570
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
222 participants
Where
1 siteChina
Study dates
16 Jan 2026to 6 Aug 2028
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • West China School of Medicine

    Chengdu, Sichuan, 610041

    Recruiting

Other trials in China

About this study

Official 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

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.

Read the 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.

Being tested
D-2570, Placebo
Keywords
PsA (Psoriatic Arthritis)
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07315061
Study groupRoleWhat they receive
D-2570 (experimental arm 1)ExperimentalSubjects 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.
Receives: Drug: D-2570
D-2570 (experimental arm 2)ExperimentalSubjects 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.
Receives: Drug: D-2570
placeboPlacebo comparatorSubjects 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.
Receives: Drug: D-2570; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (4)
  1. Proportion of subjects achieving minimal disease activity at Week 12 of treatment;

    Measured: Week 12

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

    Measured: Week 12

  3. Plasma concentrations of D-2570

    Measured: 0-week 24

  4. safety(AEs)

    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.

    Measured: 0-week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start16 Jan 2026
  3. Primary completion15 Aug 2027 (estimated)
  4. Study completion6 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07315061
Sponsor's protocol ID
D2570-204
Acronym
D2570-204
Status last verified
Apr 2026
First submitted
18 Dec 2025
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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