A Study to Evaluate 608 in Patients with Non- Radiographic Axial Spondyloarthritis (nr-axSpA)

Last updated: March 6, 2025
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Ankylosing Spondylitis

Treatment

Placebo

608

Clinical Study ID

NCT06222671
SSGJ-608-nr-axSpA-II-01
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ArthritisInternational Society (ASAS) axial spondyloarthritis criteria

  3. Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormalC-reactive protein)

  4. Total back pain as measured by NRS ≥ 4 at baseline

Exclusion

Exclusion Criteria:

  1. Patients with other uncontrolled active inflammatory diseases.

  2. Clinical laboratory tests and other tests that reveal abnormalities with clinicalsignificance

  3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined bypositive 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 Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 22, 2024
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Site 01

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Site 03

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Site 05

    Chongqing, Chongqing 400010
    China

    Active - Recruiting

  • Site 02

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Site 04

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Site 06

    Shenzhen, Shenzhen 518020
    China

    Site Not Available

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