UveitisPhase 4NCT07773623
An Interventional Study of Upadacitinib Extended-Release Tablets in Patients With Refractory Uveitis
A Phase 4 study testing Upadacitinib Extended-Release Tablets in people with Uveitis, run by Tianjin Medical University at 1 site in China.
Trial summary
Upadacitinib sustained-release tablets have not yet been approved for the treatment of uveitis. The current use falls under the category of "off-label medication", which means providing patients with potentially beneficial treatment options in the absence of formal approval. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- What is being tested?
- Upadacitinib Extended-Release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1.Patients voluntarily participate in the study and sign the informed consent form.
- 2.Male and female subjects aged 12 to 70 years (inclusive). 3.Patients with autoimmune uveitis who have been on long-term treatment with corticosteroids combined with immunosuppressants, with or without adalimumab, but have shown no remission or have had recurrent episodes.
- 4.Subjects (and their partners) agree to have no pregnancy plans during the entire trial period and within 1 month after the end of the study, and voluntarily take contraceptive measures.
Who cannot join
- 1.History or symptoms suggestive of demyelinating disease (including myelitis and optic neuritis) on neurological examination, including but not limited to optic neuritis.
- 2.Significant media opacities that interfere with visual acuity testing, anterior segment evaluation, or fundus examination, or inability to dilate the pupil adequately.
- 3.Monocular patients judged by the investigator to be unsuitable for enrollment.
- 4.Intravitreal antiVEGF (vascular endothelial growth factor) therapy (e.g., ranibizumab, aflibercept, or conbercept) within 90 days prior to baseline.
- 5.Ozurdex (dexamethasone implant) insertion within 6 months prior to baseline. 6.Intravitreal methotrexate injection within 90 days prior to baseline. 7.Subjects meeting any of the following criteria related to latent or active tuberculosis (TB) infection:
- History of active TB within ≤ 3 years before screening (however, if > 3 years and with documented evidence of adequate treatment, enrollment may be permitted);
Show all 12Show fewer
- Signs or symptoms suggestive of active TB during history taking and/or physical examination at screening;
- Recent close contact with a person with active TB;
- Positive T cell test for TB infection at screening. If the initial test result is indeterminate, the subject will be excluded from the study. For subjects who have already completed appropriate standard treatment for latent TB prior to screening and have no additional risk factors, imaging findings, or specific evidence supporting latent or active TB, exceptions to positive or indeterminate results may be considered, provided that the investigator consults with a qualified infectious disease specialist to assess the risk of TB (including extrapulmonary TB) and discusses with the sponsor.
- 8.Positive for hepatitis C antibody, or HIV antibody, or Treponema pallidum antibody at screening.
- 9.Presence of severe, progressive, or uncontrolled symptoms of renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiovascular, neurological, or cerebral disease. Subjects with malignancies, or any condition that, in the investigator's opinion, would place the patient at undue risk by participating in the study.
- 10.History of severe allergic or anaphylactic reactions to upadacitinib or any of its components
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Clinical Study of Treatment With Upadacitinib Extended-Release Tablets Among Patients Suffering From Refractory Uveitis
Upadacitinib sustained-release tablets have not yet been approved for the treatment of uveitis. The current use falls under the category of "off-label medication", which means providing patients with potentially beneficial treatment options in the absence of formal approval. Based on existing case reports and mechanism studies, we believe that upadacitinib sustained-release tablets have potential therapeutic value for patients with uveitis who have not responded well to traditional treatment regimens or those who have not responded well to traditional treatment combined with biologics (adalimumab). Therefore, we plan to conduct this clinical study to systematically evaluate its efficacy and safety in patients with refractory uveitis and explore better treatment options for these patients.
- Conditions
- Uveitis
- Being tested
- Upadacitinib Extended-Release Tablets
- Keywords
- Upadacitinib, Refractory uveitis
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upadacitinib Extended-Release TabletsDrug
An interventional study of upadacitinib extended-release tablets (15 mg once daily) in patients with refractory uveitis.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib sustained-release tablets for the treatment of refractory non-infectious uveit | Experimental | Upadacitinib Extended-Release Tablet Intervention Group (Self-before-after Controlled Study) Intervention: Oral administration of upadacitinib extended-release tablet at a daily dose of 15 mg, once daily. For enrolled subjects, upadacitinib extended-release tablet is used to replace the prior adalimumab therapy. Glucocorticoids and other immunosuppressive agents are not mandatory to discontinue; their doses can be individually adjusted by investigators according to subjects' ocular inflammatory conditions. The total follow-up observation period of the study is 24 months. Peripheral blood samples of subjects are collected at baseline enrollment, 3-month, 6-month, 12-month and 24-month time-points after treatment initiation. Investigators perform ocular and systemic safety and efficacy assessments and record adverse events in accordance with the study protocol. Receives: Drug: Upadacitinib Extended-Release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Month 3, 6, 12 and 24.
Best-corrected visual acuity (BCVA) will be recorded as ETDRS letter scores converted from Snellen charts. BCVA will be measured at baseline, Month 3, Month 6, Month 12 and Month 24. The change in letter score from baseline will be calculated at each time-point to evaluate the effect of upadacitinib on subjects' visual function.
Measured: From enrollment to the end of treatment at 24 months
Change from Baseline in Anterior Chamber Cell Grade at Month 3, 6, 12 and 24
Anterior chamber cell grade will be assessed by slit-lamp biomicroscopy following the SUN standardized uveitis grading criteria. Assessments will be performed at baseline, Month 3, Month 6, Month 12 and Month 24. Grade changes relative to baseline will be computed at each visit for longitudinal analysis of anterior-segment intraocular inflammation over treatment.
Measured: From enrollment to the end of treatment at 24 months
Change from Baseline in Vitreous Cell/Vitreous Haze Grade at Month 3, 6, 12 and 24.
Vitreous cell and vitreous haze will be graded by slit-lamp and indirect ophthalmoscopy using the Nussenblatt standardized scoring system. Evaluations will be conducted at baseline, Month 3, Month 6, Month 12 and Month 24. Grade changes versus baseline will be calculated at each time-point to assess the therapeutic response of vitreous inflammation to upadacitinib.
Measured: 24 months from enrollment to treatment
Secondary outcomes (8)
The time for complete disappearance of all active inflammatory reactions in the eyes after treatment with upatiden sustained-release tablets
Complete resolution is defined as the absence of all active inflammatory signs in the eye, as determined by slit-lamp examination. This endpoint will be assessed at baseline, Month 3, Month 6, Month 12 and Month 24 . The time to resolution will be calculated from the date of first dose of upadacitinib to the date of the first documented absence of active inflammation
Measured: From enrollment to the end of treatment at 24 months
Incidence of Adverse Events During 24-month Follow-up
All adverse events (including infection, haematological abnormalities, liver function abnormality, thrombosis, hypersensitivity reactions, etc.) will be documented across the 24-month study period. The count, category, severity and causal relationship to study drug will be summarized for adverse events and serious adverse events.
Measured: From enrollment to the end of treatment at 24 months
Ocular complications after treatment with upatinib sustained-release tablets
Ocular complications will be evaluated using slit-lamp examination, optical coherence tomography (OCT), and fundus photography at baseline, Month 3, Month 6, and Month 12. The outcome will describe the occurrence, type, severity, and relationship to stud.
Measured: From enrollment to the end of treatment at 24 months
The usage load of hormones and immunosuppressants after treatment with upatiden sustained-release tablets
This endpoint will assess the cumulative use burden of corticosteroids and immunosuppressants, including dose, duration, and/or frequency, as documented during follow-up visits at baseline, Month 3, Month 6, Month 12, and Month 24. The outcome will quantify the overall exposure to these concomitant medications over the 24-month treatment period.
Measured: From enrollment to the end of treatment at 24 months
Occurrence of Uveitis Relapse or Exacerbation During 24-month Follow-up
Uveitis relapse/exacerbation events will be documented throughout the 24-month observation period. Relapse is defined as ≥2-grade increase in anterior-chamber cell grade, ≥2-grade increase in vitreous cell/haze grade, ≥3-line Snellen visual loss, new active retinal/choroidal lesions, new vascular leakage on fundus fluorescein angiography, or recurrent/worsening macular edema confirmed by OCT. Number, timing and frequency of relapses will be summarized.
Measured: 24 months from enrollment to treatment
Change from Baseline in Complete Blood Count Parameters at Month 3, 6, 12 and 24.
Peripheral blood samples will be collected at baseline, Month 3, Month 6, Month 12 and Month 24 for complete blood count testing, including absolute neutrophil count (ANC, cells/mm³), lymphocyte count (cells/mm³), hemoglobin (g/dL) and platelet count (10⁹/L). Changes from baseline will be calculated for each parameter to evaluate the haematological effects of upadacitinib.
Measured: 24 months from enrollment to treatment
Change from Baseline in Liver Enzyme Levels at Month 3, 6, 12 and 24
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) will be measured at baseline, Month 3, Month 6, Month 12 and Month 24, expressed in U/L. Changes from baseline will be calculated at each time-point to monitor upadacitinib-associated liver function abnormalities.
Measured: 24 months from enrollment to treatment
Change from Baseline in Lipid Profile Parameters at Month 3, 6, 12 and 24
Fasting lipid profiles, including total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), will be measured at baseline, Month 3, Month 6, Month 12 and Month 24, expressed in mmol/L. Changes from baseline will be calculated for each parameter to assess the effect of upadacitinib on lipid metabolism.
Measured: 24 months from enrollment to treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Zhang, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773623
- Sponsor's protocol ID
- KY-2026003
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Clinical Study of Treatment With Upadacitinib Extended-Release Tablets Among Patients Suffering From Refractory Uveitis
- ClinicalTrials.gov ID
- NCT07773623
- Acronym / sponsor ID
- KY-2026003
- Conditions
- Uveitis
- Keywords
- Upadacitinib, Refractory uveitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2026 (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.
Upadacitinib sustained-release tablets have not yet been approved for the treatment of uveitis. The current use falls under the category of "off-label medication", which means providing patients with potentially beneficial treatment options in the absence of formal approval. Based on existing case reports and mechanism studies, we believe that upadacitinib sustained-release tablets have potential therapeutic value for patients with uveitis who have not responded well to traditional treatment regimens or those who have not responded well to traditional treatment combined with biologics (adalimumab). Therefore, we plan to conduct this clinical study to systematically evaluate its efficacy and safety in patients with refractory uveitis and explore better treatment options for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib sustained-release tablets for the treatment of refractory non-infectious uveit | Experimental | Drug: Upadacitinib Extended-Release TabletsUpadacitinib Extended-Release Tablet Intervention Group (Self-before-after Controlled Study) Intervention: Oral administration of upadacitinib extended-release tablet at a daily dose of 15 mg, once daily. For enrolled subjects, upadacitinib extended-release tablet is used to replace the prior adalimumab therapy. Glucocorticoids and other immunosuppressive agents are not mandatory to discontinue; their doses can be individually adjusted by investigators according to subjects' ocular inflammatory conditions. The total follow-up observation period of the study is 24 months. Peripheral blood samples of subjects are collected at baseline enrollment, 3-month, 6-month, 12-month and 24-month time-points after treatment initiation. Investigators perform ocular and systemic safety and efficacy assessments and record adverse events in accordance with the study protocol. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Patients voluntarily participate in the study and sign the informed consent form.
- 2.Male and female subjects aged 12 to 70 years (inclusive). 3.Patients with autoimmune uveitis who have been on long-term treatment with corticosteroids combined with immunosuppressants, with or without adalimumab, but have shown no remission or have had recurrent episodes.
- 4.Subjects (and their partners) agree to have no pregnancy plans during the entire trial period and within 1 month after the end of the study, and voluntarily take contraceptive measures.
Key exclusion criteria (12 listed)
- 1.History or symptoms suggestive of demyelinating disease (including myelitis and optic neuritis) on neurological examination, including but not limited to optic neuritis.
- 2.Significant media opacities that interfere with visual acuity testing, anterior segment evaluation, or fundus examination, or inability to dilate the pupil adequately.
- 3.Monocular patients judged by the investigator to be unsuitable for enrollment.
- 4.Intravitreal antiVEGF (vascular endothelial growth factor) therapy (e.g., ranibizumab, aflibercept, or conbercept) within 90 days prior to baseline.
- 5.Ozurdex (dexamethasone implant) insertion within 6 months prior to baseline. 6.Intravitreal methotrexate injection within 90 days prior to baseline. 7.Subjects meeting any of the following criteria related to latent or active tuberculosis (TB) infection:
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 |
|---|---|---|
| Upadacitinib Extended-Release TabletsAn interventional study of upadacitinib extended-release tablets (15 mg once daily) in patients with refractory uveitis. | Drug | Upadacitinib sustained-release tablets for the treatment of refractory non-infectious uveit |
Primary outcome
Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Month 3, 6, 12 and 24.
Time frame: From enrollment to the end of treatment at 24 months
Best-corrected visual acuity (BCVA) will be recorded as ETDRS letter scores converted from Snellen charts. BCVA will be measured at baseline, Month 3, Month 6, Month 12 and Month 24. The change in letter score from baseline will be calculated at each time-point to evaluate the effect of upadacitinib on subjects' visual function.
Change from Baseline in Anterior Chamber Cell Grade at Month 3, 6, 12 and 24
Time frame: From enrollment to the end of treatment at 24 months
Anterior chamber cell grade will be assessed by slit-lamp biomicroscopy following the SUN standardized uveitis grading criteria. Assessments will be performed at baseline, Month 3, Month 6, Month 12 and Month 24. Grade changes relative to baseline will be computed at each visit for longitudinal analysis of anterior-segment intraocular inflammation over treatment.
Change from Baseline in Vitreous Cell/Vitreous Haze Grade at Month 3, 6, 12 and 24.
Time frame: 24 months from enrollment to treatment
Vitreous cell and vitreous haze will be graded by slit-lamp and indirect ophthalmoscopy using the Nussenblatt standardized scoring system. Evaluations will be conducted at baseline, Month 3, Month 6, Month 12 and Month 24. Grade changes versus baseline will be calculated at each time-point to assess the therapeutic response of vitreous inflammation to upadacitinib.
8 secondary outcomes
The time for complete disappearance of all active inflammatory reactions in the eyes after treatment with upatiden sustained-release tablets
Time frame: From enrollment to the end of treatment at 24 months
Incidence of Adverse Events During 24-month Follow-up
Time frame: From enrollment to the end of treatment at 24 months
Ocular complications after treatment with upatinib sustained-release tablets
Time frame: From enrollment to the end of treatment at 24 months
The usage load of hormones and immunosuppressants after treatment with upatiden sustained-release tablets
Time frame: From enrollment to the end of treatment at 24 months
Occurrence of Uveitis Relapse or Exacerbation During 24-month Follow-up
Time frame: 24 months from enrollment to treatment
Change from Baseline in Complete Blood Count Parameters at Month 3, 6, 12 and 24.
Time frame: 24 months from enrollment to treatment
Change from Baseline in Liver Enzyme Levels at Month 3, 6, 12 and 24
Time frame: 24 months from enrollment to treatment
Change from Baseline in Lipid Profile Parameters at Month 3, 6, 12 and 24
Time frame: 24 months from enrollment to treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Upadacitinib Extended-Release Tablets in people with Uveitis, run by Tianjin Medical University 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 3 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Month 3, 6, 12 and 24. (time frame: From enrollment to the end of treatment at 24 months). The study lists 3 primary outcomes in all. 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 19 Aug 2026.