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

Lux Biosciences

Status and phase: Completed; Phase 3

Conditions: Uveitis, Anterior; Panuveitis

Treatments: Drug: LX211; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404885

EudraCT No: 2006-006545-13

LX211-03-UV

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 13+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

LX211, 0.2 mg/kg

Active Comparator group

Treatment:

Drug: LX211

Drug: LX211

Drug: LX211

LX211, 0.4 mg/kg

Active Comparator group

Treatment:

Drug: LX211

Drug: LX211

Drug: LX211

LX211, 0.6 mg/kg

Active Comparator group

Treatment:

Drug: LX211

Drug: LX211

Drug: LX211