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Not yet taking people in ChinaPhase 3

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 the Efficacy and Safty of 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)

Key facts

Where
Beijing, ChinaSee the site
Phase
Phase 3

Where in China

  • BeijingBeijing, ChinaNo longer taking part

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Trial details

Who runs it
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Trial code
NCT07349329
Record updated
16 January 2026
Original description
This study will evaluate the efficacy and safety of 608 in patients with nr-axSpA.Read full original descriptionShow less

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients With Non-radiographic Axial Spondyloarthritis (Nr-axSpA)

This study will evaluate the efficacy 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.

ClinicalTrials.gov NCT07349329