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Ankylosing SpondylitisPhase 3NCT05861102

Efficacy and Safety Study of Jaktinib in Subjects 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS). 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?
Yes, some participants may receive a placebo
How many people
265 participants
Where
1 siteChina
Study dates
20 Jul 2023to 9 Jun 2025
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

  • Participants must be able to understand the study and signed the informed consent.
  • 18-65 years, male or female.
  • Participants with a clinical diagnosis of ankylosing spondylitis (AS), and radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS(1984).
  • Participants 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.
  • Participants may be receiving the following Disease-Modifying Anti-Rheumatic Drugs(DMARDs) at the time of the screening visit. These medications should be continued throughout the entire study and doses should remain unchanged.
  • Participants 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.
  • Participants who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation.
  • Participants receiving non-prohibited concomitant medications for any reason must be willing to stay on a stable regimen as defined in the protocol.

Who cannot join

  • History of known or suspected complete ankylosis of the spine.
  • Any subject with condition affecting oral drug absorption.
  • Participants taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) within 4 weeks before randomization.
  • Participants on any other DMARDs within 4 weeks or five half-lives (whichever is longer) of the drug prior to the Baseline visit.
  • Participants has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis, mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age.
  • Significant trauma or surgery procedure within 8 weeks prior to randomization, or any planned elective surgery during the study period.
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  • Participants with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
  • Participants with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery.
  • Use of any investigational drug and/or devices within 4 weeks of randomization or a period of 5 half-lives of the investigational drug, whichever is longer.

Trial locations and contacts

1 site in 1 country.

China1 site

  • RenJi Hospital

    Shanghai, Shanghai Municipality, 200001

Other trials in China

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).

Read the detailed description

Approximately 258 eligible subjects (129 per arm) will be randomized in a 1:1 ratio to Jaktinib 100mg BID (twice daily) or matching placebo BID for a total of 16 weeks of blinded treatment. During the 16-week treatment period subjects will visit the clinic every two weeks until the Week 4 visit and then every 4 weeks until the completion of Week 16.

Being tested
Jaktinib, 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.

  • JaktinibDrug

    Participants will receive 100 mg Jaktinib orally twice daily for 16 weeks

  • PlaceboDrug

    Participants will receive matching placebo orally twice daily for 16 weeks

Study groups in NCT05861102
Study groupRoleWhat they receive
Jaktinib 100mg BID (twice daily)ExperimentalNot described
Receives: Drug: Jaktinib
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 16

    ASAS40 is defined as a >= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.

    Measured: Week 16

Secondary outcomes (3)

  1. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.

    ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])

    Measured: Week 16

  2. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 2、4、8 and 12.

    ASAS40 is defined as a >= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.

    Measured: Week 2、4、8 and 12

  3. Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 2、4、8 and 12.

    ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])

    Measured: Week 2、4、8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2023
  2. Study start20 Jul 2023
  3. Primary completion9 Jun 2025
  4. Study completion9 Jun 2025

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05861102
Sponsor's protocol ID
ZGJAK029
Status last verified
Sep 2026
First submitted
6 May 2023
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 8 inclusion and 9 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 22 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. 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?

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 with Assessment in Ankylosing Spondylitis (ASAS) 40 response 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 NCT05861102.

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 22 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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