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

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.

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.

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.