RecruitingPhase 3NCT07261644

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

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)

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

500 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Ankylosing Spondylitis

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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.

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Interventions

DRUG608 dose

608 subcutaneous (SC) injection.

DRUGPlacebo

Placebo subcutaneous (SC) injection.

Locations(1)

Site 01

Beijing, Beijing Municipality, China

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NCT07261644

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