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NCT Number: NCT07261644

A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)

This study will evaluate the efficacy and safety of 608 in patients with AS.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of 608 compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 60.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and comply with the protocol requirements, participate and sign the informed consent form (ICF) voluntarily;
  • At least 18 years of age at the time of signing the ICF, with no gender restrictions;
  • Meet the 1984 modified New York criteria for ankylosing spondylitis (AS);
  • Have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or have contraindications/intolerance to NSAIDs treatment;
  • Willing to practice contraception and have no plans for pregnancy, sperm donation, or egg donation from the screening period until at least 6 months after the last dose.

Exclusion criteria

  • 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.

Treatment and study plan

608 dose

Drug

608 subcutaneous (SC) injection.

Placebo

Drug

Placebo subcutaneous (SC) injection.

Primary outcomes

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

    Time frame: Week 16.

    Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the NRS signifies higher severity.

Secondary outcomes

  1. The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response.

    Time frame: Week 16.

    Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the NRS signifies higher severity.

Other outcomes

  1. 608 Concentration in Serum.

    Time frame: Up to 60 Weeks.

    The concentration of 608 in Serum.

Study contacts

Contact information is provided by the study sponsor or research team.

Qing hong Zhou

CONTACT

[email protected]

+86 18911301578

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis (AS)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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