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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05651880

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Active Non-anterior Non-infectious Uveitis	Drug: Baricitinib 4 MG	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient treated with baricitinib 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.	Drug: Baricitinib 4 MG 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)

Arm

Intervention/Treatment

Experimental: Patient treated with baricitinib

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.

Drug: Baricitinib 4 MG

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)

Outcome Measures

Primary Outcome Measures

Number of patients with complete remission [6 months]

Secondary Outcome Measures

Number of patients with complete remission [1 month]
Number of patients with complete remission [3 months]
Number of serious events [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator: Mathilde LECLERCQ, MD, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT05651880

Other Study ID Numbers:

2020/0420/HP

First Posted:

Dec 15, 2022

Last Update Posted:

Dec 15, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uveitis

Study Results

No Results Posted as of Dec 15, 2022