A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404742

Acronym

LUMINATE

Enrollment

232

Registered

2006-11-29

Start date

2007-01-31

Completion date

2009-05-31

Last updated

2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panuveitis, Uveitis, Intermediate, Uveitis, Posterior

Keywords

uveitis, calcineurin

Brief summary

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

Interventions

DRUGPlacebo

PO BID

DRUGLX211

0.2 mg/kg, twice a day (BID)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Inclusion criteria

* A documented history of non-infectious intermediate, anterior and intermediate, posterior or panuveitis. * Minimum prescribed therapy upon enrollment is one or more of the following: * systemic prednisone or equivalent averaging ≥ 10 mg/day * at least 2 periocular/intravitreal corticosteroid administrations for control of inflammatory disease within the previous 8 months (but not within 6 weeks of randomization). * at least one, but not more than 2 immunosuppressive drugs from among the following compounds: cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, methotrexate * Subjects with clinically quiescent uveitis in both eyes at enrollment and who have been on a stable treatment regimen for a minimum of 6 weeks * Best-corrected distance visual acuity in the worst involved eye of 20/400 or better (ETDRS logMAR \<1.34) * Subjects not planning to undergo elective ocular surgery during the study

Exclusion criteria

* Evidence of active, uncontrolled non-infectious uveitis * Periocular administration of corticosteroids within the previous 6 weeks. * Uveitis of infectious etiology * Uncontrolled glaucoma * Clinically suspected or confirmed central nervous system or ocular lymphoma * History or diagnosis of Behçet's disease * Primary diagnosis of anterior uveitis

Design outcomes

Primary

Measure	Time frame
recurrence of ocular inflammation	26 weeks

Secondary

Measure	Time frame
BCVA	26 weeks
systemic corticosteroid usage	26 weeks

Countries

Austria, Canada, France, Germany, India, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026