A Phase 3 interventional study of SHR-1314 Injection and SHR-1314 Placebo Injection in Active Non-radiographic Axial Spondyloarthritis, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
33 studies on the registry are indexed under Non-Radiographic Axial Spondyloarthritis; 12 are open to participants now.
This study's planned enrollment of 380 is above the median of 225 across 20 interventional studies indexed under Non-Radiographic Axial Spondyloarthritis.
Browse Non-Radiographic Axial Spondyloarthritis studies →Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 104 studies on the registry; 73 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period.
Drug: SHR-1314 Injection
Subjects will receive SHR-1314 placebo injection in the core treatment period and receive SHR-1314 injection in the extended treatment period.
Drug: SHR-1314 Injection · Drug: SHR-1314 Placebo Injection
SHR-1314 injection.
SHR-1314 placebo injection.
Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).
Time frame: At the 16th week after administration.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Feb 2028, 34 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Vunakizumab
Non-Radiographic Axial Spondyloarthritis →
Suzhou Suncadia Biopharmaceuticals Co., Ltd. →