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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00404612
• Date of registration: 27/11/2006
• Prospective Registration: Yes
• Primary sponsor: Lux Biosciences, Inc.
• Public title: A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis LUMINATE
• Scientific title: 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
• Date of first enrolment: January 2007
• Target sample size: 218
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00404612
• 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:

- 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



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

Health Condition(s) or Problem(s) studied

Panuveitis

Uveitis, Intermediate

Uveitis, Posterior

Intervention(s)

Drug: LX211

Drug: Placebo

Primary Outcome(s)

vitreous haze [Time Frame: 16 and 24 weeks]

Secondary Outcome(s)

BCVA [Time Frame: 24 weeks]

Secondary ID(s)

EudraCT No: 2006-006543-31

LX211-01-UV

Source(s) of Monetary Support

Please refer to primary and secondary sponsors