Ankylosing SpondylitisPhase 2ASNCT04507659
Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis
A Phase 2 study testing Jaktinib Hydrochloride Tablets in people with Ankylosing Spondylitis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Jaktinib Hydrochloride Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 2 Aug 2022
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65, both gender;
- Active Ankylosing Spondylitis;
- Participants who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs) and still have active disease, or Participants who are intolerant to NSAIDs and stop the drug;
- Participants receiving low-dose oral glucocorticoid therapy (≤10mg/d prednisone) should maintain a stable medication regimen for at least 4 weeks before the first dose of this study. Do not adjust the dose during the entire study period except in emergency situations.
- Participants receiving other non-prohibited co-drugs should maintain a stable medication regimen for at least 7 days before the first dose of this study;
- Understand and voluntarily signed informed consent.
Who cannot join
- A history of known or suspected complete spinal rigidity, or clinical and imaging confirmed complete spinal rigidity;
- A history of any other autoimmune rheumatic disease;
- Any history of joint prosthesis infection, and the prosthesis is still in place;
- Participants who are using strong opioid analgesics (such as methadone, hydromorphone, morphine, etc.);
- Participants who have been treated with any JAK inhibitors (such as Tofacitinib, Baricitinib, Ruxolitinib, Filgotinib, Upadacitinib, etc.);
- Participants who have drug abuse or alcohol dependence;
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- Participants who have had herpes virus infection in the past month;
- Participants who have a history of venous thrombosis (regardless of current treatment);
- Any significant clinical and laboratory abnormalities that the investigator believes will affect the safety evaluator；
- Participants who cannot be treated and followed up according to the trial protocol;
- Any Participant considered by the investigator to be unsuitable to participate in this clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase Ⅱ Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing Spondylitis
This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites.
Read the detailed description
The study is divided into two stages, the first stage (1-16 weeks) is the main study; the second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Jaktinib Hydrochloride Tablets, 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.
Jaktinib Hydrochloride TabletsDrug
Also called Jaktinib
Morning: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets; Evening: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets.
Jaktinib Hydrochloride TabletsDrug
Also called Jaktinib
Morning: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets; Evening: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets.
PlaceboDrug
Morning: 1*75mg simulated tablet, 2*50mg simulated tablets; Evening: 1*75mg simulated tablet, 2*50mg simulated tablets.
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 100mg | Experimental | 100 mg bid.po Receives: Drug: Jaktinib Hydrochloride Tablets |
| Jaktinib 75mg | Experimental | 75 mg bid.po Receives: Drug: Jaktinib Hydrochloride Tablets |
| Placebo | Placebo comparator | Placebo bid.po Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Measured: Week 16
Secondary outcomes (4)
Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32
It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.The score range was 0-10, the low score meant that the spinal movement was better.
Measured: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32
ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Measured: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32
It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The score range was 0-10, the low score meant that the spinal movement was better.
Measured: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32
ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Measured: Week 2,4,8,12,16,20,24,32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Dec 2020
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
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 Zelgen Biopharmaceuticals Co.,LtdThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunde Bao, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507659
- Sponsor's protocol ID
- ZGJAK008
- Acronym
- AS
- Status last verified
- Mar 2023
- First submitted
- 4 Aug 2020
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Bao C, Dai Q, Xu A, Ye Y. Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial. RMD Open. 2025 Jan 2;11(1):e004865. doi: 10.1136/rmdopen-2024-004865.
PubMed 39753296
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase Ⅱ Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04507659
- Acronym / sponsor ID
- AS / ZGJAK008
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 11 Aug 2020 (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 trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites.
Detailed description
The study is divided into two stages, the first stage (1-16 weeks) is the main study; the second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 100mg | Experimental | Drug: Jaktinib Hydrochloride Tablets100 mg bid.po |
| Jaktinib 75mg | Experimental | Drug: Jaktinib Hydrochloride Tablets75 mg bid.po |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo bid.po |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65, both gender;
- Active Ankylosing Spondylitis;
- Participants who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs) and still have active disease, or Participants who are intolerant to NSAIDs and stop the drug;
- Participants receiving low-dose oral glucocorticoid therapy (≤10mg/d prednisone) should maintain a stable medication regimen for at least 4 weeks before the first dose of this study. Do not adjust the dose during the entire study period except in emergency situations.
- Participants receiving other non-prohibited co-drugs should maintain a stable medication regimen for at least 7 days before the first dose of this study;
Key exclusion criteria (11 listed)
- A history of known or suspected complete spinal rigidity, or clinical and imaging confirmed complete spinal rigidity;
- A history of any other autoimmune rheumatic disease;
- Any history of joint prosthesis infection, and the prosthesis is still in place;
- Participants who are using strong opioid analgesics (such as methadone, hydromorphone, morphine, etc.);
- Participants who have been treated with any JAK inhibitors (such as Tofacitinib, Baricitinib, Ruxolitinib, Filgotinib, Upadacitinib, etc.);
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 |
|---|---|---|
| Jaktinib Hydrochloride TabletsAlso: JaktinibMorning: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets; Evening: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets. | Drug | Jaktinib 75mg |
| Jaktinib Hydrochloride TabletsAlso: JaktinibMorning: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets; Evening: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets. | Drug | Jaktinib 100mg |
| PlaceboMorning: 1*75mg simulated tablet, 2*50mg simulated tablets; Evening: 1*75mg simulated tablet, 2*50mg simulated tablets. | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
Time frame: Week 16
ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
4 secondary outcomes
Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32
Time frame: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32
Time frame: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32
Time frame: Week 2,4,8,12,16,20,24,32
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32
Time frame: Week 2,4,8,12,16,20,24,32
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 29 Mar 2023.
- Derived from this study: PubMed 39753296Wang J, Bao C, Dai Q, Xu A, Ye Y. Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial. RMD Open. 2025 Jan 2;11(1):e004865. doi: 10.1136/rmdopen-2024-004865.
- 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.
Chunde Bao, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Jaktinib Hydrochloride Tablets in people with Ankylosing Spondylitis, run by Suzhou Zelgen 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 6 inclusion and 11 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 29 Mar 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16 (time frame: Week 16). 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 NCT04507659, 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 29 Mar 2023.