Tests drug 608 against placebo in non-radiographic axial spondyloarthritis
Tests drug 608 against a placebo in adults with non-radiographic axial spondyloarthritis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
Key facts
- Where
- Beijing, Chongqing, Nanjing, Shenzhen, and Zhengzhou, ChinaSee the 6 sites
- Phase
- Phase 2
Where in China
- BeijingBeijing, ChinaTaking people
- BeijingBeijing, ChinaTaking people
- ChongqingChongqing, ChinaTaking people
- NanjingNanjing, ChinaTaking people
- ShenzhenShenzhen, ChinaNot yet recruiting
- ZhengzhouZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Trial code
- NCT06222671
- Record updated
- 11 March 2025
- Original description
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.Read full original descriptionShow less
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 will evaluate the effect and safety of 608 in patients with nr-axSpA.
Inclusion: 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.
Exclusion: 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; Known with allergic or intolerant to mometasone furoate spray or 608/placebo; Clinical laboratory tests and other tests that reveal abnormalities with clinical significance.