Actively Recruiting
A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2024-11-12
200
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant voluntarily signs an informed consent form before any research procedures begin
- Meets the 2006 psoriatic arthritis classification criteria (CASPAR) at screening
- Has active psoriatic arthritis before randomization
- Has active plaque psoriasis (at least one plaque skin lesion) at screening or a history of plaque psoriasis
- Previously treated with csDMARDs and/or NSAIDs but still has active psoriatic arthritis
You will not qualify if you...
- Has a history of drug-induced psoriasis, other active inflammatory or autoimmune diseases, organ transplantation, lymphocytic proliferation, or severe infections
- Has received psoriatic arthritis or psoriasis drugs, including intra-articular injections or plant preparations, within a certain recent period
- Is allergic to the drug ingredients, excipients in this study, or other biological agents
- Has a history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huashan Hospital of the Shanghai FuDan University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
S
Su Zhang, M.M
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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