Viewing Study NCT03847272



Ignite Creation Date: 2024-05-06 @ 12:47 PM
Last Modification Date: 2024-10-26 @ 1:04 PM
Study NCT ID: NCT03847272
Status: TERMINATED
Last Update Posted: 2024-01-12
First Post: 2019-02-15

Brief Title: A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis NISU
Sponsor: Centre Hospitalier Universitaire Dijon
Organization: Centre Hospitalier Universitaire Dijon

Study Overview

Official Title: A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis NISU
Status: TERMINATED
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The long inclusion period meant that the question could not be answered within an appropriate timeframe
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: USTEKINISU
Brief Summary: Uveitis is characterized by inflammation of the uvea which is the middle portion of the eye The greatest challenge for the treatment of uveitis is patients who have inflammation involving the posterior segment either primarily in the vitreous intermediate uveitis the choroid or retina posterior uveitis or involving the entire eye panuveitis The term uveitis denotes a heterogeneous collection of diseases including infections systemic immune-mediated diseases like sarcoidosis and immune-mediated syndromes confined to the eye like sympathetic ophthalmia Despite the progress in recent decades uveitis and the related intraocular inflammation are comparable to diabetes or macular degeneration as a cause of lost quality-adjusted life years due to visual morbidity and as such are a significant public health problem The Standardization of Uveitis Nomenclature Working Group Guidelines recommend the use of corticosteroids as the first-line therapy for patients with active uveitis However long-term corticosteroid treatment can cause serious systemic and ocular side effects such as hypertension diabetes osteoporosis cataract and glaucoma that limit its use in the treatment of uveitis Alternatively immunomodulatory therapy IMT drugs are given as steroid-sparing agents and have shown good clinical results for both systemic diseases and ocular inflammatory diseases Given the side effects of chronic corticosteroid therapy and better understanding of the mechanisms of autoimmune-mediated uveitis the aim of the treatment for patients with noninfectious uveitis is steroid-free remission with IMT While uveitis is a heterogeneous disease with polygenic and environmental factors most forms of immune-mediated uveitis are thought to be due to an imbalance between regulatory mechanisms that inhibit the immune system and inflammatory mechanisms which have evolved to rid the body of infectious organisms but which can result in immune-mediated often chronic disease if they are activated outside the context of the immediate infection The pathophysiology of non-infectious uveitis involves the rupture of peripheral tolerance resulting in auto-aggressive Th1 or Th17 lymphocytes reaching the eye L-12 and IL-23 are two key cytokines involved in Th1 and Th17 polarization in uveitis respectively Furthermore these two cytokines share a common subunit p40 Ustekinumab a humanized anti-p40 monoclonal antibody is able to target both IL-12 and IL-23 pathways thus disrupting Th1 and Th17 immune responses

Decreasing the dose as well as the duration of treatment with GC is of particular importance in uveitis and ustekinumab which selectively inhibits Th1 and Th17 pathways in the inflammatory cascade could provide a ideal additional therapy for non-infectious severe uveitis NISU to reach this objective

Therefore in the present study we propose to evaluate the efficacy and safety of ustekinumab for the treatment of NISU
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None