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

NCT05651880 | Not Yet Recruiting Phase 3

• 1 other identifier: 2020/0420/HP
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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

Conditions

Active Non-anterior Non-infectious Uveitis

Outcome Measures

Primary Outcomes (1)

• Number of patients with complete remission

  6 months

Secondary Outcomes (3)

• Number of patients with complete remission

  1 month

• Number of patients with complete remission

  3 months

• Number of serious events

  6 months

Study Arms (1)

Patient treated with baricitinib

EXPERIMENTAL

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

Interventions

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)

Patient treated with baricitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with diagnosis of non-anterior non-infectious uveitis, refractory to at least one line of biotherapy (anti-TNF alpha, tocilizumab)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

MeSH Terms

Interventions

baricitinib

Study Officials

• Mathilde LECLERCQ, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde LECLERCQ, MD

CONTACT

+3323288; mathilde.leclercq@chu-rouen.fr

Armelle GUIDOTTI

CONTACT

+3323288; armelle.guidotti@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share