RecruitingRecruiting
A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis
NCT07315061 · InventisBio Co., Ltd
In plain English
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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
About this study
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.
Eligibility 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.
Study design
Enrollment target: 222 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-01-16
Estimated completion: 2028-08-06
Last updated: 2026-04-22
Interventions
Drug: D-2570Drug: Placebo
Primary outcomes
- • Proportion of subjects achieving ACR20 at Week 12 of treatment. (Week 12)
Sponsor
InventisBio Co., Ltd · industry
Contacts & investigators
Contactyi liu, Dr. · contact · zhongchen.ma@inventisbio.com · 13401466347
Contactchen zhong ma · contact · zhongchen.ma@inventisbio.com · 13401466347
Investigatoryi liu, phD · principal_investigator, West China School of Medicine
All locations (1)
West China School of MedicineRecruiting
Chengdu, Sichuan, China