NCT06222671 A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
| NCT ID | NCT06222671 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. |
| Condition | Axial Spondyloarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-03-22 |
| Primary Completion | 2025-09-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 180 participants in total. It began in 2024-03-22 with a primary completion date of 2025-09-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
Eligibility 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.
Contact & Investigator
Qinghong Zhou, BS
STUDY DIRECTOR
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Frequently Asked Questions
Who can join the NCT06222671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Axial Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06222671 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06222671 currently recruiting?
Yes, NCT06222671 is actively recruiting participants. Contact the research team at zhouqinghong@3sbio.com for enrollment information.
Where is the NCT06222671 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Chongqing, China, Zhengzhou, China and 2 additional locations.
Who is sponsoring the NCT06222671 clinical trial?
NCT06222671 is sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. The principal investigator is Qinghong Zhou, BS at Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. The trial plans to enroll 180 participants.