Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of 608 in Adults With Active Ankylosing Spondylitis
Led by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Updated on 2025-12-10
500
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of the drug 608 in adult patients with active ankylosing spondylitis (AS). The trial aims to demonstrate the clinical efficacy of 608 at week 16 compared to placebo and to assess both safety and tolerability up to week 16, with ongoing long-term safety monitoring up to week 60. This is a phase 3, randomized, double-blind, placebo-controlled study involving adults aged 18 years and older. Participants receive either 608 or a placebo through subcutaneous injections. The treatment period includes 16 weeks to evaluate primary and secondary outcomes, followed by continued observation for safety up to week 60. The study includes a placebo control group to compare responses and assess the effect of 608 on ankylosing spondylitis symptoms. During the trial, participants undergo assessments to measure their response according to the Assessment of Spondylo Arthritis International Society (ASAS) criteria at week 16. Safety and tolerability are also closely monitored throughout the study and the extended follow-up period. The total involvement includes periodic evaluations, laboratory tests, and clinical monitoring to ensure participant safety and to measure treatment effects over time.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and comply with the protocol requirements and voluntarily sign the informed consent form
- At least 18 years old at the time of signing the informed consent form
- Meet the 1984 modified New York criteria for ankylosing spondylitis
- Have had inadequate response to NSAIDs or have contraindications or intolerance to NSAIDs
- Willing to use contraception and avoid pregnancy, sperm donation, or egg donation from screening until 6 months after last dose
You will not qualify if you...
- Presence of other uncontrolled active inflammatory diseases
- Clinical laboratory or other test abnormalities with clinical significance
- Active infections with Hepatitis B, Hepatitis C, or HIV at screening
- History of cancer
- Known or suspected history of immunosuppression
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 - 16 weeks
Participants receive subcutaneous injections of 608 or placebo to evaluate efficacy and safety.
Regular visits during the 16-week treatment period
Duration - Up to Week 60
Participants are monitored for long-term safety after completing treatment.
Visits scheduled up to Week 60 for safety assessments
Trial Site Locations
Total: 1 location
1
Site 01
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Q
Qing hong Zhou
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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