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Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis (JAKUVEITE)
EU CTIS ID: 2024-513802-77-00
What this study is testing
To evaluate the efficacy of baricitinib, a JAK1 and 2 inhibitor, in the management of non-infectious non-anterior uveitis multi-refractory to two lines of biotherapy (anti-TNF alpha and tocilizumab) after 6 months of treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of non-anterior non-infectious uveitis refractory to two lines of biotherapy (anti-TNF alpha and tocilizumab). Refractory uveitis is defined as: a. Either active uveitis, namely: anterior chamber inflammation >2+ [Tyndall, SUN scale (1)] and/or vitreous inflammation >2+ [Vitreous Haze, SUN scale (1)] and/or the presence of retinal vasculitides and/or the presence of cystoid macular edema (central macular thickness greater than strictly 300 μm measured on optical coherence tomography, associated with visualization of intraretinal logettes). b. or inactive uveitis but with corticosteroid dependence ≥ 10 mg/day for at least 3 months.
- Need for discontinuation of biotherapy and conventional immunosuppressants (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date.
- Patient of legal age who has read and understood the information letter and signed the consent form.
- Patient affiliated to a social security plan.
- Patient under 65 years old
- Female: a. Of childbearing age (defined by the CTFG as fertile, post-menarche to post-menopause, except in cases of permanent infertility): Using effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 4 weeks prior to inclusion, during treatment, and up to 1 week after cessation of treatment And, Presenting a negative urine pregnancy test at inclusion; b. Surgically infertile: no ovaries and/or uterus and/or bilateral salpingectomy; c. Menopausal: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
You likely can't join if
- Isolated anterior uveitis
- Previous treatment with JAK inhibitors
- 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.
- 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.
- Treatment with OAT3 inhibitors with high inhibitory potential such as probenecid, leflunomide, teriflunomide
- Vaccination with a live vaccine or live attenuated vaccine within 15 days prior to inclusion
See the full eligibility criteria
Who can join
- Diagnosis of non-anterior non-infectious uveitis refractory to two lines of biotherapy (anti-TNF alpha and tocilizumab). Refractory uveitis is defined as: a. Either active uveitis, namely: anterior chamber inflammation >2+ [Tyndall, SUN scale (1)] and/or vitreous inflammation >2+ [Vitreous Haze, SUN scale (1)] and/or the presence of retinal vasculitides and/or the presence of cystoid macular edema (central macular thickness greater than strictly 300 μm measured on optical coherence tomography, associated with visualization of intraretinal logettes). b. or inactive uveitis but with corticosteroid dependence ≥ 10 mg/day for at least 3 months.
- Need for discontinuation of biotherapy and conventional immunosuppressants (mycofenolate mofetil, methotrexate, azathioprine, cyclosporine, interferon alpha 2a) for at least 10 days prior to the inclusion date.
- Patient of legal age who has read and understood the information letter and signed the consent form.
- Patient affiliated to a social security plan.
- Patient under 65 years old
- Female: a. Of childbearing age (defined by the CTFG as fertile, post-menarche to post-menopause, except in cases of permanent infertility): Using effective contraception (estrogen-progestin or intrauterine device or tubal ligation) for at least 4 weeks prior to inclusion, during treatment, and up to 1 week after cessation of treatment And, Presenting a negative urine pregnancy test at inclusion; b. Surgically infertile: no ovaries and/or uterus and/or bilateral salpingectomy; c. Menopausal: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)
- Negative quantiferon less than 6 months old (6 months included) and normal chest x-ray less than 3 months old (3 months included) or positive quantiferon in patients with a history of previously treated latent TB according to current recommendations
- HIV, HCV and HBV serology with no active infection, less than 1 month old (1 month included)
What rules you out
- Isolated anterior uveitis
- Previous treatment with JAK inhibitors
- 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.
- 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.
- Treatment with OAT3 inhibitors with high inhibitory potential such as probenecid, leflunomide, teriflunomide
- Vaccination with a live vaccine or live attenuated vaccine within 15 days prior to inclusion
- Risk factor for developing a malignancy (patient has or has had a malignancy)
- Personal history of venous thromboembolic disease.
- Presence of a hereditary coagulation disorder
- Risk factors for major cardiovascular events (such as a history of heart attack or stroke)
- Smokers or Former Long-term smokers
- Infectious uveitis
- Pregnant or parturient or breastfeeding woman or lack of proven contraception
- Obese patient with a body mass index ≥ 40 kg/m2
- Hemoglobin < 8 g / dl
- Platelet count <100,000 / mm3 or >500,000 / mm3
- Neutrophil count <1000 / mm3, lymphocyte count <500/mm3.
- Renal impairment with clearance <30 ml/min.
- Severe hepatic impairment.
- Allergy to fluorescein
- Person deprived of liberty by an administrative or judicial decision or person placed under safeguard of justice / sub guardianship or curatorship.
- Patient who has participated in another drug trial within 3 months prior to the start of the study.
- Severe uveitis threatening the visual prognosis and requiring emergency treatment with intravenous corticosteroids
- Initial visual acuity > 1.3 LogMAR in at least one eye.
- Corneal or lens opacity that prevents fundus visualization or may require cataract surgery during the study.
- Contraindication to baricitinib (OLUMIANT 2 and 4 mg film-coated tablets): Hypersensitivity to the active substance or to any of the excipients.
- Contraindication to mydriasis.
- Refractory glaucoma in either eye.
- Monophthalmic patient.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.