This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
2. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
3. There is active PsA before randomization;
4. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
5. Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.
Exclusion Criteria:
1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
Primary outcome measure(s)
Proportion of subjects achieving ACR 20 improvement at week 24 — Week 24
Trial sites (1)
Facility
City
Region
Status
Huashan Hospital of the Shanghai FuDan University
Shanghai
Shanghai Municipality
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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