A Study of LX211 in Active Sight Threatening, 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

NCT00404612

EudraCT No: 2006-006543-31

LX211-01-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 uveitis

Enrollment: 218 patients

Sex: All

Ages: 13+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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218 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