PsA (Psoriatic Arthritis)
Conditions
Keywords
PsA (Psoriatic Arthritis)
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.
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.
Interventions
DRUGD-2570
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.
DRUGPlacebo
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.
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving ACR20 at Week 12 of treatment. | Week 12 | Definition of ACR20：The number of tender joints and swollen joints both decreased by at least 20% compared with the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
China
Contacts
CONTACTyi liu, Dr.
CONTACTchen zhong ma
PRINCIPAL_INVESTIGATORyi liu, phD
West China School of Medicine
Outcome results
None listed