About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Parallel
Treatments tested in this trial
D-2570
DrugSubjects 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
DrugSubjects 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Proportion of subjects achieving minimal disease activity at Week 12 of treatment;
Proportion of subjects achieving very low disease activity at Week 12 of treatment;
Plasma concentrations of D-2570
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.
Sponsors and contacts
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