Tests drug 608 against placebo in adults with active ankylosing spondylitis
Tests drug 608 against a placebo in adults with active ankylosing spondylitis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- BeijingBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Trial code
- NCT07261644
- Record updated
- 10 December 2025
- Original description
This study will evaluate the efficacy and safety of 608 in patients with AS.Read full original descriptionShow less
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis (AS)
This study will evaluate the efficacy and safety of 608 in patients with AS.
Inclusion: Able to understand and comply with the protocol requirements, participate and sign the informed consent form (ICF) voluntarily; At least 18 years of age at the time of signing the ICF, with no gender restrictions; Meet the 1984 modified New York criteria for ankylosing spondylitis (AS); Have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or have contraindications/intolerance to NSAIDs treatment; Willing to practice contraception and have no plans for pregnancy, sperm donation, or egg donation from the screening period until at least 6 months after the last dose.
Exclusion: Patients with other uncontrolled active inflammatory diseases; Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening; History of cancer; Known or suspected history of immunosuppression; Clinical laboratory tests and other tests that reveal abnormalities with clinical significance.