Active Non-radiographic Axial SpondyloarthritisPhase 3NCT06860750
A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
A Phase 3 study testing SHR-1314 Injection in people with Active Non-radiographic Axial Spondyloarthritis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Active Non-radiographic Axial Spondyloarthritis
- What is being tested?
- SHR-1314 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2025to Dec 2028
- 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
- Age ≥ 18 years at the time of signing the informed consent form, regardless of gender.
- BMI (Body Mass Index) ≥ 18 kg/m² at the time of screening.
- Presence of objective signs of inflammation at the time of screening.
- The subject voluntarily signs the ICF (informed consent form) before the start of any study-related procedures.
- The subject is able to communicate effectively with the investigator, understands and is willing to strictly adhere to the requirements of the clinical study protocol to complete the study.
Who cannot join
- Subjects with active systemic infection or severe infection.
- Subjects with active tuberculosis or latent tuberculosis infection.
- Subjects with lymphoma or lymphoproliferative disease.
- Subjects with uncontrolled hypertension.
- Subjects with history of malignancy within the past 5 years or current malignancy.
- Subjects with moderate to severe congestive heart failure.
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- Subjects with history of organ transplantation, or severe, progressive, or uncontrolled diseases of any organ system.
- Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG at the time of screening.
- Pregnant or breastfeeding women.
- known allergy to the study drug or any of its components.
- Subjects with history of alcohol abuse or illegal drug use within the past year.
- Receipt of a live vaccine within 12 weeks before randomization, or plans to receive a live vaccine during the study period.
- Blood donation of approximately 500 mL within 8 weeks before randomization, or plans to donate blood during the study period.
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Jian Zhu, +86-010- 55499314, Jian_jzhu@126.com
Jian Zhu
About this study
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
- Being tested
- SHR-1314 Injection, SHR-1314 Placebo Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314 InjectionDrug
SHR-1314 injection.
SHR-1314 Placebo InjectionDrug
SHR-1314 placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1314 Injection | Experimental | Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period. Receives: Drug: SHR-1314 Injection |
| SHR-1314 Placebo Injection | Placebo comparator | Subjects will receive SHR-1314 placebo injection in the core treatment period and receive SHR-1314 injection in the extended treatment period. Receives: Drug: SHR-1314 Injection; Drug: SHR-1314 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).
Measured: At the 16th week after administration.
Secondary outcomes (3)
Proportion of participants achieving ASAS 20 (ankylosing spondylitis disease activity score).
Measured: At the 16th week after administration.
Change in CRP (C-reactive protein) value from baseline.
Measured: At the 16th week after administration.
AEs (adverse events).
Measured: Up to 60 weeks after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start29 Apr 2025
- Primary completionFeb 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active Non-radiographic Axial SpondyloarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
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
- NCT06860750
- Sponsor's protocol ID
- SHR-1314-306
- Status last verified
- Jun 2025
- First submitted
- 2 Mar 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT06860750
- Acronym / sponsor ID
- SHR-1314-306
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Mar 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.
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
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 |
|---|---|---|
| SHR-1314 Injection | Experimental | Drug: SHR-1314 InjectionSubjects will receive SHR-1314 injection in the core treatment period and the extended treatment period. |
| SHR-1314 Placebo Injection | Placebo comparator | Drug: SHR-1314 Injection, Drug: SHR-1314 Placebo InjectionSubjects will receive SHR-1314 placebo injection in the core treatment period and receive SHR-1314 injection in the extended treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years at the time of signing the informed consent form, regardless of gender.
- BMI (Body Mass Index) ≥ 18 kg/m² at the time of screening.
- Presence of objective signs of inflammation at the time of screening.
- The subject voluntarily signs the ICF (informed consent form) before the start of any study-related procedures.
- The subject is able to communicate effectively with the investigator, understands and is willing to strictly adhere to the requirements of the clinical study protocol to complete the study.
Key exclusion criteria (13 listed)
- Subjects with active systemic infection or severe infection.
- Subjects with active tuberculosis or latent tuberculosis infection.
- Subjects with lymphoma or lymphoproliferative disease.
- Subjects with uncontrolled hypertension.
- Subjects with history of malignancy within the past 5 years or current malignancy.
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-1314 InjectionSHR-1314 injection. | Drug | SHR-1314 Injection, SHR-1314 Placebo Injection |
| SHR-1314 Placebo InjectionSHR-1314 placebo injection. | Drug | SHR-1314 Placebo Injection |
Primary outcome
Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).
Time frame: At the 16th week after administration.
3 secondary outcomes
Proportion of participants achieving ASAS 20 (ankylosing spondylitis disease activity score).
Time frame: At the 16th week after administration.
Change in CRP (C-reactive protein) value from baseline.
Time frame: At the 16th week after administration.
AEs (adverse events).
Time frame: Up to 60 weeks after administration.
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 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 SHR-1314 Injection in people with Active Non-radiographic Axial Spondyloarthritis, 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 5 inclusion and 13 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 22 Jun 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 Lihua Lin (+86-0518-82342973, lihua.lin.ll12@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score). (time frame: At the 16th week after administration.). 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 22 Jun 2025.