Ankylosing SpondylitisPhase 3NCT05861128
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
A Phase 3 study testing Jaktinib in people with Ankylosing Spondylitis, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 1 site in China.
Trial summary
The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2023to 4 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The investigators concluded that the participants continued to benefit from treatment with Jaktinib.
- The participants have been fully informed and voluntarily signed informed consent.
- The participants completed the ZGJAK029 study for 16 weeks of treatment and visitation and had good compliance.
- The interval between the participants' first dose and the last dose of ZGJAK029 ≤ 4 weeks.
Who cannot join
- There were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal.
- Within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; HIV-positive, syphilis, HBV infection, HCV infection.
- The investigators considered participants unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Jaktinib
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JaktinibDrug
Participants will receive 100 mg Jaktinib orally twice daily for 32 weeks
| Study group | Role | What they receive |
|---|---|---|
| Jaktinib 100mg BID (twice daily) | Experimental | Not described Receives: Drug: Jaktinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks
Treatment-emergent AEs were events that occurred between first dose of study drug and up to 32 weeks that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to Week 32
Secondary outcomes (4)
Percentage of Participants Achieving ASAS20 Response at Week 4, 8, 12, 16，20，24，28 and 32
ASAS20 assess 4 domains: PGA of Disease (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (BASFI; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: >= 20% improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.
Measured: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Percentage of Participants Achieving ASAS40 Response at Week 4, 8, 12, 16，20，24，28 and 32
ASAS40 assessed 4 domains: the "PGA" (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (from BASFI: assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). ASAS40 response: >=40% and >=2 units improvement in >=3 domains and no worsening at all in the remaining domain.
Measured: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Week 4, 8, 12, 16，20，24，28 and 32
Participants marked their level of total back pain on a numerical rating scale (NRS) ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.
Measured: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Percentage of Participants Achieving ASAS 5/6 Response at Week 4, 8, 12, 16，20，24，28 and 32
ASAS 5/6 consists of 6 domains: 4 used in ASAS20 - PGA (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), Spinal Pain (total back pain) (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (using BASFI which assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (using BASDAI, mean of Q 5 and 6, which assess disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity), CRP (was measured in mg per liter) and Spinal mobility was measured in centimeter and calculated as mean of right and left measurements of lateral spinal flexion from BASMI. ASAS 5/6: defined as >=20% improvement in at least 5 domains.
Measured: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start10 Nov 2023
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunde Bao, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861128
- Sponsor's protocol ID
- ZGJAK030
- Status last verified
- Sep 2026
- First submitted
- 6 May 2023
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
- ClinicalTrials.gov ID
- NCT05861128
- Acronym / sponsor ID
- ZGJAK030
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 16 May 2023 (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 purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jaktinib 100mg BID (twice daily) | Experimental | Drug: Jaktinib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The investigators concluded that the participants continued to benefit from treatment with Jaktinib.
- The participants have been fully informed and voluntarily signed informed consent.
- The participants completed the ZGJAK029 study for 16 weeks of treatment and visitation and had good compliance.
- The interval between the participants' first dose and the last dose of ZGJAK029 ≤ 4 weeks.
Key exclusion criteria (3 listed)
- There were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal.
- Within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; HIV-positive, syphilis, HBV infection, HCV infection.
- The investigators considered participants unsuitable for this study.
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 |
|---|---|---|
| JaktinibParticipants will receive 100 mg Jaktinib orally twice daily for 32 weeks | Drug | Jaktinib 100mg BID (twice daily) |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks
Time frame: Baseline up to Week 32
Treatment-emergent AEs were events that occurred between first dose of study drug and up to 32 weeks that were absent before treatment or that worsened relative to pretreatment state.
4 secondary outcomes
Percentage of Participants Achieving ASAS20 Response at Week 4, 8, 12, 16，20，24，28 and 32
Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Percentage of Participants Achieving ASAS40 Response at Week 4, 8, 12, 16，20，24，28 and 32
Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Week 4, 8, 12, 16，20，24，28 and 32
Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Percentage of Participants Achieving ASAS 5/6 Response at Week 4, 8, 12, 16，20，24，28 and 32
Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 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 24 Sep 2026.
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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 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 3 study testing Jaktinib 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 4 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: finished, as of the sponsor's last update on 24 Sep 2026. 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 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?
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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks (time frame: Baseline up to Week 32). 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 24 Sep 2026.