Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05651880

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de ROUEN

Rouen, 76031, France

Location contact

Mathilde Leclercq, Dr

CONTACT

[email protected]

Mathilde Leclercq, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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. 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.
  • 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 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.
  • Personal history of venous thromboembolic disease.

Treatment and study plan

Baricitinib 4 MG

Drug

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 outcomes

  1. Number of patients with complete remission

    Time frame: 6 months

Secondary outcomes

  1. Number of patients with complete remission

    Time frame: 1 month

  2. Number of patients with complete remission

    Time frame: 3 months

  3. Number of serious events

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Armelle GUIDOTTI

CONTACT

[email protected]

+3323288 ext. 8265

Mathilde LECLERCQ, MD

CONTACT

[email protected]

+3323288 ext. 9120

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: JAKUVEITE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 15, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.