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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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

Description

The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo in patients with nr-axSpA.

Eligibility

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.

Study details
    Axial Spondyloarthritis

NCT06222671

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

15 October 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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