Non-radiographic Axial SpondyloarthritisPhase 3NCT05324631
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis
A Phase 3 study testing SHR0302 in people with Non-radiographic Axial Spondyloarthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-radiographic Axial Spondyloarthritis
- What is being tested?
- SHR0302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2022to 11 Dec 2024
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed informed consent.
- BMI ≥18 kg/m2.
- Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).
- Participant must have baseline disease activity as defined by having a 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.
- Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
- If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline, the stable doses should have lasted for more than 4 weeks already.
Who cannot join
- Pregnant women or refuse to receive contraception during the study.
- Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the 1.5 times the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100005
Xuan Zhang, Doctor, +86-13699268153, zxlab@outlook.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Non-Radiographic Axial Spondyloarthritis Subjects
This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.
- Conditions
- Non-radiographic Axial Spondyloarthritis
- Being tested
- SHR0302, SHR0302 placebo
- Medical subject headings
- Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302Drug
SHR0302, oral, once daily
SHR0302 placeboDrug
SHR0302 placebo, oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | SHR0302 Receives: Drug: SHR0302 |
| Treatment group B | Placebo comparator | SHR0302 Placebo Receives: Drug: SHR0302 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12
Measured: Week 12
Secondary outcomes (8)
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12
Measured: Week 12
Percentage of Participants With ASAS 20 Response at week 12
Measured: Week 12
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12
Measured: Week 12
Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24
Measured: Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24
Measured: Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24
Measured: Week 12 and Week 24
Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24
Measured: Week 12 and Week 24
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start16 Aug 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion11 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-radiographic Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Model description
- SHR0302 compared with placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324631
- Sponsor's protocol ID
- SHR0302-305
- Status last verified
- Sep 2022
- First submitted
- 6 Apr 2022
- Last updated
- 2 Sep 2022
- 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Non-Radiographic Axial Spondyloarthritis Subjects
- ClinicalTrials.gov ID
- NCT05324631
- Acronym / sponsor ID
- SHR0302-305
- Conditions
- Non-radiographic Axial Spondyloarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 11 Dec 2024 (estimated)
- First posted
- 12 Apr 2022 (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 is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- SHR0302 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR0302SHR0302 |
| Treatment group B | Placebo comparator | Drug: SHR0302 placeboSHR0302 Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide signed informed consent.
- BMI ≥18 kg/m2.
- Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).
- Participant must have baseline disease activity as defined by having a 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.
- Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
Key exclusion criteria (3 listed)
- Pregnant women or refuse to receive contraception during the study.
- Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the 1.5 times the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
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 |
|---|---|---|
| SHR0302SHR0302, oral, once daily | Drug | Treatment group A |
| SHR0302 placeboSHR0302 placebo, oral, once daily | Drug | Treatment group B |
Primary outcome
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12
Time frame: Week 12
8 secondary outcomes
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12
Time frame: Week 12
Percentage of Participants With ASAS 20 Response at week 12
Time frame: Week 12
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12
Time frame: Week 12
Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24
Time frame: Week 12 and Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Non-radiographic Axial Spondyloarthritis
Active, not recruitingPhase 4
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
Non-radiographic Axial Spondyloarthritis
Not yet recruitingObservational study
A Study to Assess the Safety of Subcutaneous Secukinumab for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
Axial Spondyloarthritis, Ankylosing Spondylitis
Active, not recruitingObservational study
The REFLECT Study- Flares in axSpA
Axial Spondyloarthritis (AxSpA), Axial Spondyloarthritis, Non-Radiographic
Not yet recruitingPhase 2
Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy
Axial Spondyloarthritis, Ankylosing Spondylitis
Not yet recruitingPhase 4
Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study
Axial Spondyloarthritis, Axial Spondyloarthritis, Non-Radiographic
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.
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 SHR0302 in people with Non-radiographic Axial Spondyloarthritis, run by Jiangsu HengRui Medicine 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 6 inclusion and 3 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 2 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuan Zhang ((+86)13436522766, zxlab@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12 (time frame: Week 12). 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 2 Sep 2022; AzTrials last refreshed its copy on 26 Oct 2026.