A Phase 3 interventional study of 608 dose and Placebo in Ankylosing Spondylitis, sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of 608 in patients with AS.
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.
498 studies on the registry are indexed under Spondylitis, Ankylosing; 89 are open to participants now.
This study's planned enrollment of 500 is above the median of 84 across 275 interventional studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing studies →Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. is the lead sponsor of 56 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
608 subcutaneous (SC) injection.
Drug: 608 dose
Placebo subcutaneous (SC) injection.
Drug: Placebo
608 subcutaneous (SC) injection.
Placebo subcutaneous (SC) injection.
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.
Time frame: Week 16.
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 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). 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.
Time frame: Week 16.
608 Concentration in Serum.
The concentration of 608 in Serum.
Time frame: Up to 60 Weeks.
Plan to share: No
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.