Ankylosing SpondylitisPhase 2/3NCT04840485
Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis
A Phase 2/3 study testing SHR-1314 in people with Ankylosing Spondylitis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis 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?
- SHR-1314
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 548 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2021to 28 Feb 2024
- Phase
- Phase 2/3
- 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
- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs
Who cannot join
- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
- Conditions
- Ankylosing Spondylitis
- Being tested
- SHR-1314, 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.
SHR-1314Drug
SHR-1314 high dose
SHR-1314Drug
SHR-1314 low-dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR-1314 |
| Treatment group B | Experimental | Not described Receives: Drug: SHR-1314 |
| Treatment group C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks
Measured: 16 Weeks
Secondary outcomes (5)
Percentage of Participants Responded for ASAS 20 Response at 32 Weeks
Measured: 32 Weeks
Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks
Measured: 16 and 32 Weeks
Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks
Measured: 16 and 32 Weeks
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks
Measured: 16 and 32 Weeks
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks
Measured: 16 and 32 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start9 Jun 2021
- Primary completion3 Nov 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840485
- Sponsor's protocol ID
- SHR-1314-302
- Status last verified
- May 2024
- First submitted
- 7 Apr 2021
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu J, Zhao C, Mi C, Liu S, Wu R, Li T, Duan X, Sun L, Yang L, He X, Liu W, Li Y, Ma L, Du H, Liu Y, Chen G, Zhang H, Wang T, Liu X, Shi X, Liu J, Wu H, Sun H, Xue Y, Chai K, Li H, Hu J, Dong F, Lin L, Du Q, Bai X, Huang F. Vunakizumab for Radiographic Axial Spondyloarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611632. doi: 10.1001/jamanetworkopen.2026.11632.
PubMed 42101839
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04840485
- Acronym / sponsor ID
- SHR-1314-302
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 12 Apr 2021 (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.
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR-1314 |
| Treatment group B | Experimental | Drug: SHR-1314 |
| Treatment group C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs
Key exclusion criteria (1 listed)
- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
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 |
|---|---|---|
| SHR-1314SHR-1314 high dose | Drug | Treatment group A |
| SHR-1314SHR-1314 low-dose | Drug | Treatment group B |
| PlaceboPlacebo | Drug | Treatment group C |
Primary outcome
Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks
Time frame: 16 Weeks
5 secondary outcomes
Percentage of Participants Responded for ASAS 20 Response at 32 Weeks
Time frame: 32 Weeks
Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks
Time frame: 16 and 32 Weeks
Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks
Time frame: 16 and 32 Weeks
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks
Time frame: 16 and 32 Weeks
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks
Time frame: 16 and 32 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 42101839Zhu J, Zhao C, Mi C, Liu S, Wu R, Li T, Duan X, Sun L, Yang L, He X, Liu W, Li Y, Ma L, Du H, Liu Y, Chen G, Zhang H, Wang T, Liu X, Shi X, Liu J, Wu H, Sun H, Xue Y, Chai K, Li H, Hu J, Dong F, Lin L, Du Q, Bai X, Huang F. Vunakizumab for Radiographic Axial Spondyloarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611632. doi: 10.1001/jamanetworkopen.2026.11632.
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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 2/3 study testing SHR-1314 in people with Ankylosing Spondylitis, run by Suzhou Suncadia Biopharmaceuticals 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 May 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840485, which also lists 1 linked publication.
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 22 May 2024.