Axial SpondyloarthritisPhase 1NCT03704428
Safety, Tolerability and PK of SHR1314 in axSpA
A Phase 1 study testing SHR-1314 in people with Axial Spondyloarthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- SHR-1314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2018to 14 Jan 2020
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.
- Have a history of back pain ≥3 months with age at onset <45 years.
- Have active axSpA defined as BASDAI ≥4 at screening and baseline.
- Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.
- In the past had an inadequate response to at least 1 or 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
- If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
Who cannot join
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
- Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
- Total ankylosis of the spine.
- Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.
- Have either a current diagnosis or a recent history of malignant disease.
- Are pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis
The main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.
Read the detailed description
This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
- Conditions
- Axial Spondyloarthritis
- Being tested
- SHR-1314
- Keywords
- SHR1314
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Drug
Also called Placebo
Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 1 Receives: Drug: SHR-1314 |
| Cohort 2 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 2 Receives: Drug: SHR-1314 |
| Cohort 3 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 3 Receives: Drug: SHR-1314 |
| Cohort 4 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 4 Receives: Drug: SHR-1314 |
| Cohort 5 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 5 Receives: Drug: SHR-1314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events.
- Incidence of Treatment-Emergent Adverse Events
- Incidence of Injection site reaction
Measured: Baseline to 169 days after dose administration
Secondary outcomes (5)
Maximum observed serum concentration (Cmax) of SHR-1314
maximum concentration (Cmax)
Measured: Baseline to 169 days after dose administration
Time to maximum observed serum concentration (tmax) of SHR-1314
Time to maximum concentration (Tmax)
Measured: Baseline to 169 days after dose administration
Time to elimination half-life (t1/2) of SHR-1314
t1/2
Measured: Baseline to 169 days after dose administration
Assessment of development of Anti-drug Antibodies (ADAs)
Incidence of development of Anti-drug Antibodies (ADAs)
Measured: Baseline to 169 days after dose administration
Proportion of Participants Achieving an ASAS20 Response
ASAS20 Response
Measured: Week2, 4, 6, 8, 12,16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start19 Apr 2018
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Sun, MD, Principal investigator, People's Liberation Army General HospitalXin Chang, MD, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704428
- Sponsor's protocol ID
- SHR-1314-AS-102
- Status last verified
- Jan 2018
- First submitted
- 24 Sep 2018
- Last updated
- 13 Jan 2021
- 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 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, MAD Study to Evaluation of Safety, Tolerability and PK of SHR1314 With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT03704428
- Acronym / sponsor ID
- SHR-1314-AS-102
- Conditions
- Axial Spondyloarthritis
- Keywords
- SHR1314
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 12 Oct 2018 (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 main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.
Detailed description
This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SHR-1314Multiple subcutaneous injections of SHR-1314 dose 1 |
| Cohort 2 | Experimental | Drug: SHR-1314Multiple subcutaneous injections of SHR-1314 dose 2 |
| Cohort 3 | Experimental | Drug: SHR-1314Multiple subcutaneous injections of SHR-1314 dose 3 |
| Cohort 4 | Experimental | Drug: SHR-1314Multiple subcutaneous injections of SHR-1314 dose 4 |
| Cohort 5 | Experimental | Drug: SHR-1314Multiple subcutaneous injections of SHR-1314 dose 5 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of axial spondyloarthritis (axSpA) and fulfilling the 2009 ASAS classification criteria.
- Have a history of back pain ≥3 months with age at onset <45 years.
- Have active axSpA defined as BASDAI ≥4 at screening and baseline.
- Have objective signs of inflammation by presence of elevated ESR and/or presence of elevated CRP.
- In the past had an inadequate response to at least 1 or 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
Key exclusion criteria (6 listed)
- History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.
- Previous exposure to other biologic drug directly targeting Interleukin (IL)-17 or Interleukin (IL)-17 receptor.
- Total ankylosis of the spine.
- Have recently received biologics, tumor necrosis factor inhibitors or other immunomodulatory agents within 12 weeks.
- Have either a current diagnosis or a recent history of malignant disease.
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-1314Also: PlaceboPharmaceutical form: Injection solution. Route of administration: subcutaneous injection. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction
Time frame: Baseline to 169 days after dose administration
Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events. 1. Incidence of Treatment-Emergent Adverse Events 2. Incidence of Injection site reaction
5 secondary outcomes
Maximum observed serum concentration (Cmax) of SHR-1314
Time frame: Baseline to 169 days after dose administration
Time to maximum observed serum concentration (tmax) of SHR-1314
Time frame: Baseline to 169 days after dose administration
Time to elimination half-life (t1/2) of SHR-1314
Time frame: Baseline to 169 days after dose administration
Assessment of development of Anti-drug Antibodies (ADAs)
Time frame: Baseline to 169 days after dose administration
Proportion of Participants Achieving an ASAS20 Response
Time frame: Week2, 4, 6, 8, 12,16
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 13 Jan 2021.
- 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.
Fei Sun, MD principal investigator
People's Liberation Army General Hospital
Xin Chang, MD principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-1314 in people with 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 6 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 13 Jan 2021. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction (time frame: Baseline to 169 days after dose 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 13 Jan 2021.