NCT06222671RecruitingPhase 2
A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
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)
Source: ClinicalTrials.gov · Last updated 11 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 10 Jan 2024
- Start date
- 22 Mar 2024
- Primary completion date
- 22 Sept 2025
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06222671
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 180
- From 22 Mar 2024 to the primary completion date, 22 Sept 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| - Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.