Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-000366-18
    Sponsor's Protocol Code Number:2020/0420/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-06-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2022-000366-18
    A.3Full title of the trial
    Efficacy and Tolerance of Baricitinib, a JAK inhibitor, in the treatment of refractory non-infectious uveitis
    Efficacité et Tolérance du Baricitinib, un inhibiteur de JAK, dans le traitement des uvéites non-infectieuses non-antérieures réfractaires
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Tolerance of Baricitinib, a JAK inhibitor, in the treatment of refractory non-infectious uveitis
    Efficacité et Tolérance du Baricitinib, un inhibiteur de JAK, dans le traitement des uvéites non-infectieuses non-antérieures réfractaires
    A.3.2Name or abbreviated title of the trial where available
    JAKUVEITE
    A.4.1Sponsor's protocol code number2020/0420/HP
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU de ROUEN
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCHU de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Rouen
    B.5.2Functional name of contact pointArmelle Guidotti
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityROUEN
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.6E-mailsecretariat.DRC@chu-rouen.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OLUMIANT
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbaricitinib
    D.3.9.1CAS number 1187594-09-7
    D.3.9.3Other descriptive nameBaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active non-anterior non-infectious uveitis
    E.1.1.1Medical condition in easily understood language
    Active non-anterior non-infectious uveitis
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10066681
    E.1.2Term Acute uveitis
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    - evaluate the rate of complete remission at 1 month and 3 months.
    - evaluate the evolution of visual acuity at 1 month, 3 months and 6 months.
    - to evaluate the evolution of ocular inflammation at 1 month, 3 months and 6 months.
    - evaluate the evolution of retinal vasculitis lesions at 1 month, 3 months, and 6 months.
    - To evaluate the evolution of macular edema at 1 month, 3 months and 6 months.
    - to evaluate the evolution of corticosteroid dosage at 1 month, 3 months and 6 months.
    - to evaluate the tolerance of the treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of non-anterior non-infectious uveitis refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab). Refractory uveitis is defined as:
    a. Either active uveitis, i.e., anterior chamber inflammation >2+ [Tyndall, SUN scale (1)] and/or vitreous inflammation >2+ [Vitreous Haze, SUN scale (1)] and/or the presence of retinal vasculitis and/or the presence of cystoid macular edema (central macular thickness greater than strictly 300 µm measured by optical coherence tomography, associated with the visualization of intraretinal logettes)
    b. or inactive uveitis but with corticosteroid dependence ≥ 10 mg/day for at least 3 months.
    2. Need for discontinuation of biotherapy (anti-TNF alpha or tocilizumab) and conventional immunosuppressants (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date.
    3. Patient of legal age who has read and understood the information letter and signed the consent form.
    4. Patient affiliated to a social security plan.
    5. Patient under 75 years of age
    6. Female:
    a. Of childbearing age:
    - Using effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 4 weeks prior to inclusion, during treatment, and until 1 week after discontinuation of treatment
    And,
    - Presenting a negative urine pregnancy test at inclusion;
    b. Surgically infertile: no ovaries and/or uterus;
    c. Menopausal: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit).
    7. A negative quantiferon less than 6 months old (6 months included) and a normal chest x-ray less than 3 months old (3 months included) or a positive quantiferon in patients with a history of previously treated latent TB according to current recommendations.
    8. HIV, HCV and HBV serology with no active infection, less than 1 month old (1 month included).
    E.4Principal 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 placement of an 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. History of cancer within the previous 5 years, except for non-metastatic squamous cell and basal cell carcinoma of the skin.
    14. Personal history of venous thromboembolic disease.
    15. Pregnant or parturient or breastfeeding woman or proven lack of contraception
    16. Obese patient with a body mass index ≥ 30 kg/m2
    17. Hemoglobin < 8 g / dl
    18. Platelet count <100,000 / mm3 or >500,000 / mm3
    19. Neutrophil count <1000 / mm3, lymphocyte count <500/mm3.
    20. Renal impairment with clearance <30 ml/min.
    21. Severe hepatic impairment.
    22. Allergy to fluorescein
    23. Person deprived of liberty by an administrative or judicial decision or person placed under safeguard of justice / sub guardianship or curatorship.
    24. Patient who has participated in another drug trial within 3 months prior to the start of the study.
    E.5 End points
    E.5.1Primary end point(s)
    complete remission at 6 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    - Complete remission at 1 month, 3 months of treatment, according to the same parameters as defined for the primary endpoint.
    - Median change in visual acuity (LogMAR) at 1 month, 3 months and 6 months of treatment compared to baseline ophthalmic assessment.
    - Slit-lamp measurement of median change in anterior chamber inflammation according to the Tyndall, SUN (1) scale at 1 month, 3 months and 6 months of treatment compared to baseline ophthalmologic assessment.
    - Slit-lamp measurement of median change in vitreous inflammation according to the vitreous haze (SUN [1]) at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation.
    - Fluorescein angiographic analysis of vasculitis lesions at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation.
    - Optical coherence tomography measurement of median change in central macular thickness at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation.
    - Measurement of the number of patients with correction of cystoid macular edema measured by optical coherence tomography (cystoid macular thickness < 300 µm and disappearance of intraretinal logettes) at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic assessment.
    - Measurement of median change in corticosteroid dosages at 1 month, 3 months, and 6 months of treatment compared with the initial ophthalmologic evaluation.
    - EvI and EvIG on baricitinib from initiation of treatment through 6 months of follow-up.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3 and 6 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state33
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    normal treatment of the condition
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-11
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 01 22:44:35 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA