An Interventional Study of Upadacitinib Extended-Release Tablets in Patients With Refractory Uveitis

NCT07773623 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: KY-2026003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Upadacitinib; Refractory uveitis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  From enrollment to the end of treatment at 24 months

• Incidence of Adverse Events During 24-month Follow-up

  From enrollment to the end of treatment at 24 months

• Ocular complications after treatment with upatinib sustained-release tablets

  From enrollment to the end of treatment at 24 months

• The usage load of hormones and immunosuppressants after treatment with upatiden sustained-release tablets

  From enrollment to the end of treatment at 24 months

• Occurrence of Uveitis Relapse or Exacerbation During 24-month Follow-up

  24 months from enrollment to treatment

Study Arms (1)

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.

Drug: Upadacitinib Extended-Release Tablets

Interventions

Upadacitinib Extended-Release Tablets DRUG

An interventional study of upadacitinib extended-release tablets (15 mg once daily) in patients with refractory uveitis.

Upadacitinib sustained-release tablets for the treatment of refractory non-infectious uveit

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participate in the study and sign the informed consent form.
• 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.
• 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.

You may not qualify if:

• History or symptoms suggestive of demyelinating disease (including myelitis and optic neuritis) on neurological examination, including but not limited to optic neuritis.
• Significant media opacities that interfere with visual acuity testing, anterior segment evaluation, or fundus examination, or inability to dilate the pupil adequately.
• Monocular patients judged by the investigator to be unsuitable for enrollment.
• Intravitreal antiVEGF (vascular endothelial growth factor) therapy (e.g., ranibizumab, aflibercept, or conbercept) within 90 days prior to baseline.
• 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);
• 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.
• Positive for hepatitis C antibody, or HIV antibody, or Treponema pallidum antibody at screening.
• 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.
• History of severe allergic or anaphylactic reactions to upadacitinib or any of its components

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (1)

Tianjin Eye hospital

Tianjin, Tianjin Municipality, 300041, China

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 19, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-04

Locations

CN (1)