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

Lux Biosciences

Status and phase: Completed; Phase 3

Conditions: Uveitis, Intermediate; Uveitis, Posterior; Panuveitis

Treatments: Drug: LX211; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404742

EudraCT No: 2006-006544-66

LX211-02-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 clinically quiescent non-infectious uveitis

Enrollment: 232 patients

Sex: All

Ages: 13+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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232 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