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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00404742
• Date of registration: 27/11/2006
• Prospective Registration: Yes
• Primary sponsor: Lux Biosciences, Inc.
• Public title: A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis LUMINATE
• Scientific title: A Double-Masked, Placebo-Controlled, Multi-Center, Parallel-Group, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Clinically Quiescent Sight Threatening, Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis
• Date of first enrolment: January 2007
• Target sample size: 232
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00404742
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Eddy Anglade, M.D.
• Affiliation: Chief Medical Officer

Key inclusion & exclusion criteria

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



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Panuveitis

Uveitis, Posterior

Uveitis, Intermediate

Intervention(s)

Drug: LX211

Drug: Placebo

Primary Outcome(s)

recurrence of ocular inflammation [Time Frame: 26 weeks]

Secondary Outcome(s)

systemic corticosteroid usage [Time Frame: 26 weeks]

BCVA [Time Frame: 26 weeks]

Secondary ID(s)

EudraCT No: 2006-006544-66

LX211-02-UV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors