Evaluating the effects of 608 in patients with non-radiographic axial spondyloarthritis
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients With Non-radiographic Axial Spondyloarthritis (Nr-axSpA)
This study is testing a new treatment called 608 to see if it can help adults with non-radiographic axial spondyloarthritis feel better compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Locations | 6 sites (Beijing, Beijing Municipality and 5 other locations) |
| Trial ID | NCT06222671 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy, safety, and tolerability of a new treatment, 608, in patients diagnosed with non-radiographic axial spondyloarthritis (nr-axSpA). Participants will be randomly assigned to receive either the treatment or a placebo, with their responses monitored over the course of the trial. The study will include adult patients who meet specific diagnostic criteria and exhibit signs of inflammation. The goal is to provide evidence on how well 608 works compared to no treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with nr-axSpA and show objective signs of inflammation.
Not a fit: Patients with other uncontrolled inflammatory diseases or significant health issues such as active infections or a history of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of non-radiographic axial spondyloarthritis, offering relief from symptoms and enhancing quality of life for patients.
How similar studies have performed: While there have been studies on treatments for axial spondyloarthritis, the specific approach of using 608 in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female and male patients at least 18 years of age at the time of screening. 2. Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria 3. Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein) 4. Total back pain as measured by NRS ≥ 4 at baseline 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. 6. Known with allergic or intolerant to mometasone furoate spray or 608/placebo.
Where this trial is running
Beijing, Beijing Municipality and 5 other locations
- Site 01 — Beijing, Beijing Municipality, China (Recruiting)
- Site 03 — Beijing, Beijing Municipality, China (Recruiting)
- Site 05 — Chongqing, Chongqing Municipality, China (Recruiting)
- Site 02 — Zhengzhou, Henan, China (Recruiting)
- Site 04 — Nanjing, Jiangsu, China (Recruiting)
- Site 06 — Shenzhen, Shenzhen, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Xiaofeng Zeng, MD — Peking Union Medical College Hospital
- Study coordinator: Qinghong Zhou, BS
- Email: zhouqinghong@3sbio.com
- Phone: 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.