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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 608 dose
  • Placebo

Treatment groups

500 Participants
are divided into 2 treatment groups