A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-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 Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00404612

Acronym

LUMINATE

Enrollment

218

Registered

2006-11-29

Start date

2007-01-31

Completion date

2009-05-31

Last updated

2012-10-11

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 active 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

* Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis * Current uveitis therapy must conform to one of the following: 1. Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization 2. Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy 3. Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization 4. Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization 5. Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy * Grade of 2+ or higher for vitreous haze at time of enrollment * Considered by the investigator to require immunomodulatory therapy. * Not planning to undergo elective ocular surgery during the study

Exclusion criteria

* Uveitis of infectious etiology * Clinically suspected or confirmed central nervous system or ocular lymphoma * Primary diagnosis of anterior uveitis

Design outcomes

Primary

Measure	Time frame
vitreous haze	16 and 24 weeks

Secondary

Measure	Time frame
BCVA	24 weeks

Countries

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

Outcome results

None listed

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