NCT07261644RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
This study will evaluate the efficacy and safety of 608 in patients with AS.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- 7 Nov 2025
- Primary completion date
- 14 Jan 2027
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07261644
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 7 Nov 2025 to the primary completion date, 14 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with other uncontrolled active inflammatory diseases.
- 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.
Lab values
- Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.