Testing 608 in adults with active ankylosing spondylitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, placebo-controlled trial compares the efficacy and safety of 608 to placebo in adults with active ankylosing spondylitis who meet the 1984 modified New York criteria and have had an inadequate response or intolerance to NSAIDs. The primary efficacy endpoint is evaluated at Week 16, and safety and tolerability are followed through Week 60. Participants receive either 608 at the assigned dose or placebo and undergo scheduled clinical assessments, laboratory testing, and adverse event monitoring. The trial is sponsored by Sunshine Guojian Pharmaceutical and is being conducted at least at a site in Beijing, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Site 01
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Qing hong Zhou
• Email: zhouqinghong@3sbio.com
• Phone: +86 18911301578

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.