Testing 608 in adults with active ankylosing spondylitis
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)
This trial tests whether the medicine 608 helps adults with active ankylosing spondylitis and is safe to use.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07261644 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with active ankylosing spondylitis by the modified New York criteria who had inadequate response or intolerance to NSAIDs and who agree to required contraception are the intended participants.
Not a fit: People with uncontrolled other inflammatory diseases, active hepatitis B, hepatitis C, or HIV, clinically significant abnormal lab results, a history of cancer, or known immunosuppression are excluded and unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, 608 could provide an additional treatment option that reduces symptoms and improves function for adults with active ankylosing spondylitis.
How similar studies have performed: Other biologic and targeted therapies have shown benefit in ankylosing spondylitis, but the specific safety and efficacy of 608 are being tested here in a Phase 3 trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- Site 01 — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qing hong Zhou
- Email: zhouqinghong@3sbio.com
- Phone: +86 18911301578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.