D-2570 treatment for people with active psoriatic arthritis (Phase II)
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 Phase II trial tests whether the investigational medicine D-2570 helps adults with active psoriatic arthritis reduce joint pain and swelling compared with placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | InventisBio Co., Ltd Industry-sponsored |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07315061 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled multicenter Phase II trial enrolling about 222 adults with active psoriatic arthritis. Participants are randomized into three equal groups (74 per group) that differ by D-2570 dose or placebo, with identical eligibility, blinding, and outcome assessments across groups. The study measures both safety and efficacy outcomes to see if D-2570 improves joint signs and symptoms while monitoring adverse events. Standard clinical joint counts and other relevant disease activity measures will be used to compare D-2570 against placebo over the treatment period.
Who should consider this trial
Good fit: Adults aged 18 to 70 with psoriatic arthritis for at least 3 months who have active disease (at least 3 tender and 3 swollen joints) and who can give informed consent are ideal candidates.
Not a fit: People with significant uncontrolled or unstable medical conditions, recent or ongoing infections, or other exclusionary medical issues listed in the protocol are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, D-2570 could reduce joint pain and swelling and improve physical function for people with active psoriatic arthritis.
How similar studies have performed: Other drug classes have shown benefit in psoriatic arthritis, but D-2570 itself is investigational and has not been proven effective in this condition yet.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichuan
- West China School of Medicine — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: yi liu, phD — West China School of Medicine
- Study coordinator: yi liu, Dr.
- Email: zhongchen.ma@inventisbio.com
- Phone: 13401466347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.