Overview
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
Inclusion Criteria:
- The subject voluntarily signs an informed consent form before any procedures related to the research start;
- At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
- There is active PsA before randomization;
- Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
- Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.
Exclusion Criteria:
- 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.
- Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
- Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
- A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.