Evaluating the effects of 608 in patients with non-radiographic axial spondyloarthritis

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.