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Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis (JAKUVEITE)

Primary Purpose

Active Non-anterior Non-infectious Uveitis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Baricitinib 4 MG
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Non-anterior Non-infectious Uveitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with diagnosis of non-anterior non-infectious uveitis, refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab) Need to stop biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressive drugs (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date Exclusion Criteria: 1. Isolated anterior uveitis. 2. Infectious uveitis. 3. Severe uveitis threatening the visual prognosis and requiring emergency treatment with intravenous corticosteroids. 4. Initial visual acuity > 1.3 LogMAR in at least one eye. 5. Corneal or lens opacity that prevents fundus visualization or may require cataract surgery during the study. 6. Contraindication to baricitinib (OLUMIANT 2 and 4 mg film-coated tablets) : Hypersensitivity to the active substance or to any of the excipients. 7. Contraindication to mydriasis. 8. Refractory glaucoma in either eye. 9. Monophthalmic patient. 10. Previous treatment with JAK inhibitors. 11. Intraocular corticosteroid injection (subconjunctival or laterobulbar) within 1 month prior to inclusion or intravitreal corticosteroid implant within 3 months prior to inclusion. 12. Need for treatment with a biotherapy (anti-IL6, anti-IL6 receptor, anti-IL1, anti-IL12/IL23 anti-IL17, anti-BAFF) for extra-ocular involvement, during the entire study period. 13. Treatment with OAT3 inhibitors with high inhibitory potential such as probenecid, leflunomide, teriflunomide 14. 14. Vaccination with a live or live attenuated vaccine within 15 days prior to inclusion 15. History of cancer within the previous 5 years, except non-metastatic squamous cell and basal cell carcinoma of the skin. 16. Personal history of venous thromboembolic disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patient treated with baricitinib

    Arm Description

    Patient treated with baricitinib at a dose of 4 mg per day, taken orally in the morning, with one tablet per day for 6 months.

    Outcomes

    Primary Outcome Measures

    Number of patients with complete remission

    Secondary Outcome Measures

    Number of patients with complete remission
    Number of patients with complete remission
    Number of serious events

    Full Information

    First Posted
    December 7, 2022
    Last Updated
    December 7, 2022
    Sponsor
    University Hospital, Rouen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05651880
    Brief Title
    Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis
    Acronym
    JAKUVEITE
    Official Title
    Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Rouen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the efficacy of Baricitinib, a JAK1 and 2 inhibitor, in the management of non-infectious non-anterior uveitis refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab) after 6 months of treatment

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Active Non-anterior Non-infectious Uveitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient treated with baricitinib
    Arm Type
    Experimental
    Arm Description
    Patient treated with baricitinib at a dose of 4 mg per day, taken orally in the morning, with one tablet per day for 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Baricitinib 4 MG
    Intervention Description
    4 mg per day for 6 months (For patients with creatinine clearance between 30 and 60 mL/min at baseline or during the study, the dosage of baricitinib will be 2 mg daily)
    Primary Outcome Measure Information:
    Title
    Number of patients with complete remission
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of patients with complete remission
    Time Frame
    1 month
    Title
    Number of patients with complete remission
    Time Frame
    3 months
    Title
    Number of serious events
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with diagnosis of non-anterior non-infectious uveitis, refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab) Need to stop biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressive drugs (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date Exclusion Criteria: 1. Isolated anterior uveitis. 2. Infectious uveitis. 3. Severe uveitis threatening the visual prognosis and requiring emergency treatment with intravenous corticosteroids. 4. Initial visual acuity > 1.3 LogMAR in at least one eye. 5. Corneal or lens opacity that prevents fundus visualization or may require cataract surgery during the study. 6. Contraindication to baricitinib (OLUMIANT 2 and 4 mg film-coated tablets) : Hypersensitivity to the active substance or to any of the excipients. 7. Contraindication to mydriasis. 8. Refractory glaucoma in either eye. 9. Monophthalmic patient. 10. Previous treatment with JAK inhibitors. 11. Intraocular corticosteroid injection (subconjunctival or laterobulbar) within 1 month prior to inclusion or intravitreal corticosteroid implant within 3 months prior to inclusion. 12. Need for treatment with a biotherapy (anti-IL6, anti-IL6 receptor, anti-IL1, anti-IL12/IL23 anti-IL17, anti-BAFF) for extra-ocular involvement, during the entire study period. 13. Treatment with OAT3 inhibitors with high inhibitory potential such as probenecid, leflunomide, teriflunomide 14. 14. Vaccination with a live or live attenuated vaccine within 15 days prior to inclusion 15. History of cancer within the previous 5 years, except non-metastatic squamous cell and basal cell carcinoma of the skin. 16. Personal history of venous thromboembolic disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mathilde LECLERCQ, MD
    Phone
    +3323288
    Ext
    9120
    Email
    mathilde.leclercq@chu-rouen.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Armelle GUIDOTTI
    Phone
    +3323288
    Ext
    8265
    Email
    armelle.guidotti@chu-rouen.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mathilde LECLERCQ, MD
    Organizational Affiliation
    Rouen University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis

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