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

NCT07261644 | Recruiting Phase 3

• 1 other identifier: SSGJ-608-AS-III-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  Week 16.

Secondary Outcomes (1)

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

  Week 16.

Other Outcomes (1)

• 608 Concentration in Serum.

  Up to 60 Weeks.

Study Arms (2)

608 Dose

EXPERIMENTAL

608 subcutaneous (SC) injection.

Drug: 608 dose

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

608 dose DRUG

608 subcutaneous (SC) injection.

608 Dose

Placebo DRUG

Placebo subcutaneous (SC) injection.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.: lead

Study Sites (1)

Site 01

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qing hong Zhou

CONTACT

+86 18911301578; zhouqinghong@3sbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): November 18, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)