A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Axial Spondyloarthritis
In brief
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
Key facts
- Study ID
- NCT06222671
- Run by
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- People needed
- 180
- Starts
- 2024-03-22
- Expected to finish
- 2025-11-30
- Last updated by the study team
- 2025-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Female and male patients at least 18 years of age at the time of screening.
- Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
- Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
- Total back pain as measured by NRS ≥ 4 at baseline
You may not qualify if…
- 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.
- Known with allergic or intolerant to mometasone furoate spray or 608/placebo.
Where it is running
- Site 01 — Beijing, Beijing Municipality, China (enrolling)
- Site 03 — Beijing, Beijing Municipality, China (enrolling)
- Site 05 — Chongqing, Chongqing Municipality, China (enrolling)
- Site 02 — Zhengzhou, Henan, China (enrolling)
- Site 04 — Nanjing, Jiangsu, China (enrolling)
- Site 06 — Shenzhen, Shenzhen, China
Full record on ClinicalTrials.gov
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