Ankylosing SpondylitisPhase 2NCT06242652
A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
A Phase 2 study testing 608 Dose A, 608 Dose B and 608 Dose C 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 effect 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 A, 608 Dose B and 608 Dose C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2024to 15 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Female and male patients at least 18 years of age at the time of screening.
- Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
- If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit.
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.
About this study
Official title: A Multicenter, Randomized, Double-blind, Double Dummy，placebo and Positive Controlled，phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients with Ankylosing Spondylitis (AS)
This study will evaluate the effect and safety of 608 in patients with AS.
Read the detailed description
The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with AS.
- Conditions
- Ankylosing Spondylitis
- Being tested
- 608 Dose A, 608 Dose B, 608 Dose C, Adalimumab, 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 Dose ADrug
Also called SSGJ-608 Dose A
608 subcutaneous (SC) injection.
608 Dose BDrug
Also called SSGJ-608 Dose B
608 subcutaneous (SC) injection.
608 Dose CDrug
Also called SSGJ-608 Dose C
608 subcutaneous (SC) injection.
AdalimumabDrug
Also called Humira
Adalimumab subcutaneous (SC) injection.
PlaceboDrug
Placebo subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| 608 Dose A | Experimental | 608 Dose A subcutaneous (SC) injection. Receives: Drug: 608 Dose A |
| 608 Dose B | Experimental | 608 Dose B subcutaneous (SC) injection. Receives: Drug: 608 Dose B |
| 608 Dose C | Experimental | 608 Dose C subcutaneous (SC) injection. Receives: Drug: 608 Dose C |
| Positive control group | Active comparator | Adalimumab subcutaneous (SC) injection. Receives: Drug: Adalimumab |
| 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) 20 Response.
Assessment of Spondylo Arthritis 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.
Secondary outcomes (1)
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response.
Assessment of Spondylo Arthritis 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start19 Mar 2024
- Primary completion27 Feb 2025 (estimated)
- Study completion15 Jun 2025 (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.
- More trials run by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242652
- Sponsor's protocol ID
- SSGJ-608-AS-II-01
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 23 Oct 2024
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double Dummy，placebo and Positive Controlled，phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients with Ankylosing Spondylitis (AS)
- ClinicalTrials.gov ID
- NCT06242652
- Acronym / sponsor ID
- SSGJ-608-AS-II-01
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 5 Feb 2024 (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 effect and safety of 608 in patients with AS.
Detailed description
The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo and positive drug in patients with AS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 608 Dose A | Experimental | Drug: 608 Dose A608 Dose A subcutaneous (SC) injection. |
| 608 Dose B | Experimental | Drug: 608 Dose B608 Dose B subcutaneous (SC) injection. |
| 608 Dose C | Experimental | Drug: 608 Dose C608 Dose C subcutaneous (SC) injection. |
| Positive control group | Active comparator | Drug: AdalimumabAdalimumab 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 (4 listed)
- Female and male patients at least 18 years of age at the time of screening.
- Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
- If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit.
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 Dose AAlso: SSGJ-608 Dose A608 subcutaneous (SC) injection. | Drug | 608 Dose A |
| 608 Dose BAlso: SSGJ-608 Dose B608 subcutaneous (SC) injection. | Drug | 608 Dose B |
| 608 Dose CAlso: SSGJ-608 Dose C608 subcutaneous (SC) injection. | Drug | 608 Dose C |
| AdalimumabAlso: HumiraAdalimumab subcutaneous (SC) injection. | Drug | Positive control group |
| PlaceboPlacebo subcutaneous (SC) injection. | Drug | Placebo |
Primary outcome
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response.
Time frame: Week 16.
Assessment of Spondylo Arthritis 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.
1 secondary outcome
The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response.
Time frame: Week 16.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 608 Dose A, 608 Dose B and 608 Dose C 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 4 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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) 20 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 23 Oct 2024.