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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404742
First Posted: November 29, 2006
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lux Biosciences, Inc.
  Purpose
The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with clinically quiescent non-infectious uveitis

Condition Intervention Phase
Uveitis, Posterior Uveitis, Intermediate Panuveitis Drug: Placebo Drug: LX211 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Lux Biosciences, Inc.:

Primary Outcome Measures:
  • recurrence of ocular inflammation [ Time Frame: 26 weeks ]

Secondary Outcome Measures:
  • BCVA [ Time Frame: 26 weeks ]
  • systemic corticosteroid usage [ Time Frame: 26 weeks ]

Enrollment: 232
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
PO BID
Active Comparator: LX211, 0.2 mg/kg Drug: LX211
0.2 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.4 mg/kg Drug: LX211
0.4 mg/kg, twice a day (BID)
Active Comparator: LX211, 0.6 mg/kg Drug: LX211
0.6 mg/kg, twice a day (BID)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404742


  Show 41 Study Locations
Sponsors and Collaborators
Lux Biosciences, Inc.
Investigators
Study Chair: Eddy Anglade, M.D. Chief Medical Officer
  More Information

Additional Information:
Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00404742     History of Changes
Other Study ID Numbers: LX211-02-UV
EudraCT No: 2006-006544-66
First Submitted: November 27, 2006
First Posted: November 29, 2006
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Lux Biosciences, Inc.:
uveitis
calcineurin

Additional relevant MeSH terms:
Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases