A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404885

Acronym

LUMINATE

Enrollment

108

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, Anterior

Keywords

uveitis, calcineurin, inflammation

Brief summary

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

* Documented history of non-infectious anterior, anterior and intermediate- or panuveitis * Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated. * Grade of 2+ or higher for anterior chamber cells at time of enrollment * Considered by the investigator to require corticosteroid-sparing therapy. * Subjects not planning to undergo elective ocular surgery during the study

Exclusion criteria

* Uveitis of infectious etiology * Presence of an ocular toxoplasmosis scar * An immune suppression regimen that includes an alkylating agent within the previous 90 days

Design outcomes

Primary

Measure	Time frame
anterior chamber cells	16 and 24 weeks

Secondary

Measure	Time frame
BCVA	24 weeks
macular thickness	16 and 24 weeks

Countries

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

Outcome results

None listed

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