May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Design of Phase 2/3 Clinical Trials of a Novel Calcineurin Inhibitor, Lx 211, for the Treatment of Non-Infectious Uveitis
Author Affiliations & Notes
  • J. T. Rosenbaum
    Ophthalmology, Casey Eye Institute-OHSU, Portland, Oregon
  • LUMINATE Uveitis Program Study Group
    Ophthalmology, Casey Eye Institute-OHSU, Portland, Oregon
  • Footnotes
    Commercial Relationships  J.T. Rosenbaum, Lux, Bausch & Lomb, Abbott, Centocor, Genentech, Celgene, F; Lux, Bausch & Lomb, Abbott, Centocor, Genentech, Celgene, C; Lux, Bausch & Lomb, Abbott, Centocor, Genentech, R.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 3883. doi:https://doi.org/
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      J. T. Rosenbaum, LUMINATE Uveitis Program Study Group; Design of Phase 2/3 Clinical Trials of a Novel Calcineurin Inhibitor, Lx 211, for the Treatment of Non-Infectious Uveitis. Invest. Ophthalmol. Vis. Sci. 2008;49(13):3883. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : LX211 is a novel calcineurin inhibitor (CNi) possessing four-fold greater potency, an altered metabolic and pharmakokinetic profile, and potentially improved safety compared to the prototypical CNi, cyclosporine A. Three pivotal dose-ranging clinical trials have been designed to evaluate the safety and efficacy of LX211 as a corticosteroid-sparing agent for the management of non-infectious uveitis.

Methods: : Three global, prospective, double-masked, parallel-group, dose-ranging, placebo-controlled, randomized multicenter studies comprise the LUMINATE Program, which is currently in progress in the United States, Europe, and Asia. Study LX211-01-UV (LUMINATE Active) will evaluate 210 patients with active predominantly posterior manifestations. Study LX211-03-UV (LUMINATE Anterior) will evaluate 100 patients with active predominantly anterior manifestations. Study LX211-02-UV (LUMINATE Maintenance) will evaluate 220 patients whose disease is controlled and will be employed to spare the use of systemic corticosteroid and, if applicable, to replace the patient’s current poorly-tolerated corticosteroid-sparing agent.

Results: : The studies are ongoing. Primary endpoints in protocol LX211-01-UV are mean change from baseline in graded vitreous haze after 16 weeks and 24 weeks of therapy or at time of rescue. Protocol LX211-02-UV will assess proportion of subjects experiencing inflammatory exacerbation during 26 weeks of treatment. Protocol LX211-03-UV will assess mean change in graded anterior chamber cells after 16 and 24 weeks of therapy or at time of rescue. Secondary endpoints include corticosteroid utilization, rates of exacerbation, quality of life, macular edema, and visual acuity.

Conclusions: : The LUMINATE Program consists of the first prospective, randomized placebo-controlled trials for an oral corticosteroid-sparing immunosuppressive agent in different types of sight-threatening non-infectious uveitis.

Clinical Trial: : www.clinicaltrials.gov NCT00404612, 00404742, 00404885

Keywords: uveitis-clinical/animal model • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • immunomodulation/immunoregulation 
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