RecruitingPhase 3

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

China500 participantsStarted 2025-11-07

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response.

Timeframe: Week 16.

Trial details

NCT IDNCT07261644

SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-14

Contact for this trial

Qing hong Zhou

+86 18911301578 zhouqinghong@3sbio.com

View on ClinicalTrials.gov More Ankylosing Spondylitis trials