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A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)

RECRUITINGPhase 3Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Actively Recruiting
PhasePhase 3
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Started2025-11-07
Est. completion2027-01-14
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

This study will evaluate the efficacy and safety of 608 in patients with AS.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

1. Able to understand and comply with the protocol requirements, participate and sign the informed consent form (ICF) voluntarily;
2. At least 18 years of age at the time of signing the ICF, with no gender restrictions;
3. Meet the 1984 modified New York criteria for ankylosing spondylitis (AS);
4. Have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or have contraindications/intolerance to NSAIDs treatment;
5. 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:

1. Patients with other uncontrolled active inflammatory diseases.
2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
4. History of cancer.
5. Known or suspected history of immunosuppression.

Conditions2

Ankylosing SpondylitisArthritis

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