Overview
This study will evaluate the efficacy and safety of 608 in patients with AS.
Description
The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of 608 compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 60.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- Patients with other uncontrolled active inflammatory diseases.
- Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
- 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.