A Phase 4 interventional study of Upadacitinib Extended-Release Tablets in Uveitis, sponsored by Tianjin Medical University. Active, not recruiting at 1 site in China. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Tianjin Medical University · Phase 4, Interventional, and Treatment
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Tianjin Medical University is the lead sponsor of 49 studies on the registry; 30 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1.Patients voluntarily participate in the study and sign the form.
2.Male and female subjects aged 12 to 70 years (inclusive). 3.Patients with uveitis who have been on long-term treatment with combined with , 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 measures.
Exclusion Criteria:
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:
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 antibody, or 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 , 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Upadacitinib Extended-Release Tablets
An interventional study of upadacitinib extended-release tablets (15 mg once daily) in patients with refractory uveitis.
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months from enrollment to treatment
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
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months from enrollment to treatment
Plan to share: Undecided
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Upadacitinib
Tianjin Medical University