drugset / Trial / NCT06258915

Treatment FOr Corticosteroid Dependent UveitiS

NCT06258915

Phase 3 Not yet recruiting 120 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupTriple-blindTreatment

Summary

FOCUS is the first prospective randomized study comparing standard of care (mycophenolate mofetil) to adalimumab in recently active non infectious uveitis (NIU) with steroid dependency. There is no firm evidence or randomized trials that compared classical immunosuppressive compounds to biological agents; or identified the best treatment in this condition. The burden of NIU has been reduced with the use of immunosuppressive agents and biologics, raising the question of which of these compounds should be preferentially used in recently active NIU with steroid dependency.

Timeline

Start
2024-03-01
Primary completion
2027-06-01
Completion
2027-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Comparator Mycophenolate Mofetil Small molecule 2 g Oral

Indications