RecruitingPhase 2

A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)

China180 participantsStarted 2024-03-22

Plain-language summary

This study will evaluate the effect and safety of 608 in patients with nr-axSpA.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response

Timeframe: From Baseline to Week 16

NCT IDNCT06222671

SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-22

Qinghong Zhou, BS