A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-2570, Placebo.
- Who it may be relevant to
- Registry conditions: PsA (Psoriatic Arthritis). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug D-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 - Drug Placebo
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
Primary outcome measures
- Proportion of subjects achieving ACR20 at Week 12 of treatment. [Time frame: Week 12]
Secondary outcome measures (4)
- Proportion of subjects achieving minimal disease activity at Week 12 of treatment; [Time frame: Week 12]
- Proportion of subjects achieving very low disease activity at Week 12 of treatment; [Time frame: Week 12]
- Plasma concentrations of D-2570 [Time frame: 0-week 24]
- safety（AEs） [Time frame: 0-week 24]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China School of Medicine — Chengdu
Identifiers
NCT: NCT07315061 · D2570-204