Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of SHR-1314 Injection in Adults With Active Psoriatic Arthritis
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2024-11-12
200
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase III randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of SHR-1314 injection in adults with active psoriatic arthritis. This study plans to enroll 150 adult participants who meet specific criteria including having active psoriatic arthritis and plaque psoriasis or a history of it. The study aims to assess improvements in psoriatic arthritis symptoms using standardized measures such as ACR 20, 50, and 70 responses. The trial includes a 4-week screening period followed by a 24-week core treatment phase where participants receive either SHR-1314 injection or a placebo. Following this, there is a 24-week maintenance treatment period and an 8-week safety follow-up. The study is designed to compare the effects of SHR-1314 injection against placebo under carefully controlled conditions with masking of participants, investigators, and others. Participants will be involved in regular assessments throughout the study, including evaluations of their arthritis symptoms and skin lesions. The main outcome measure is the proportion of subjects achieving ACR 20 improvement at week 24, with secondary outcomes including ACR 50 and 70 improvements. Safety will be monitored during and after treatment, and the total study participation lasts approximately 60 weeks including screening, treatment, maintenance, and follow-up periods.
CONDITIONS
Brief 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 subject voluntarily signs an informed consent form before any procedures related to the research start
- Meets the 2006 psoriatic arthritis classification standard (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 disease
You will not qualify if you...
- History or presence of drug-induced psoriasis, other active inflammatory or autoimmune diseases, organ transplantation, lymphocytic proliferation, or severe infections
- Received psoriatic arthritis or psoriasis drugs such as intra-articular injections or plant preparations within a certain recent period
- Allergy to study drug ingredients, excipients, or other biological agents
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive SHR-1314 injection or placebo to evaluate efficacy and safety for psoriatic arthritis.
Visits occur periodically during the 24-week treatment period
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
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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