Ankylosing SpondylitisPhase 3NCT07261644
A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
A Phase 3 study testing 608 dose in people with Ankylosing Spondylitis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of 608 in patients with AS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- 608 dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2025to 18 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Site 01
Beijing, Beijing Municipality, 100730
Zeng Xiao feng MD, +86 13501069845, Xiaofeng.zeng@cstar.org.cn
About this study
Official 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)
This study will evaluate the efficacy and safety of 608 in patients with AS.
Read the detailed description
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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- 608 dose, Placebo
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
608 doseDrug
608 subcutaneous (SC) injection.
PlaceboDrug
Placebo subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| 608 Dose | Experimental | 608 subcutaneous (SC) injection. Receives: Drug: 608 dose |
| Placebo | Placebo comparator | Placebo subcutaneous (SC) injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16.
Secondary outcomes (1)
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.
Measured: Week 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start7 Nov 2025
- Primary completion14 Jan 2027 (estimated)
- Study completion18 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261644
- Sponsor's protocol ID
- SSGJ-608-AS-III-01
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07261644
- Acronym / sponsor ID
- SSGJ-608-AS-III-01
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 14 Jan 2027 (estimated)
- Study completion
- 18 Nov 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of 608 in patients with AS.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 608 Dose | Experimental | Drug: 608 dose608 subcutaneous (SC) injection. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo subcutaneous (SC) injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 608 dose608 subcutaneous (SC) injection. | Drug | 608 Dose |
| PlaceboPlacebo subcutaneous (SC) injection. | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response.
Time frame: Week 16.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 608 dose in people with Ankylosing Spondylitis, run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing hong Zhou (+86 18911301578, zhouqinghong@3sbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response. (time frame: Week 16.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.