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SSGJ-608 in Non-radiographic Axial Spondyloarthritis (nr-axSpA)
NCT06222671Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2024
- Primary completion
- Sep 2025
- Countries
- 1
- Sponsor
- 3S Guojian Pharmaceutical
- Modality
- Monoclonal Antibodies
- Drugs
- 608
- Conditions
- non-radiographic axial spondyloarthritis (nr-axSpA)
01
Overview
Phase 2, randomised, double-blind trial of 608 in non-radiographic axial spondyloarthritis (nr-axSpA) (3 arms), sponsored by 3S Guojian Pharmaceutical. Primary endpoint: Assessment of Spondylo Arthritis International Society 40 Response at 16 weeks. Started Mar 2024; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
608 Dose A
SSGJ-608 Dose A SC injection
608 Dose B
SSGJ-608 Dose B SC injection
Placebo
Placebo SC injection
03
Who it enrols
Adult patients with a diagnosis of axial spondyloarthritis (ASAS criteria) with objective signs of inflammation (MRI or abnormal CRP) and total back pain NRS ≥ 4. Patients with other uncontrolled inflammatory diseases, active infections (Hep B, Hep C, HIV), history of cancer, or immunosuppression are excluded.
04
Endpoints
Primary
Assessment of Spondylo Arthritis International Society 40 Response
Secondary
Assessment of Spondylo Arthritis International Society 20 Response
608 Concentration in Serum
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