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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00404742
First received: November 27, 2006
Last updated: June 21, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BCVA [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • systemic corticosteroid usage [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00404742     History of Changes
Other Study ID Numbers: LX211-02-UV, EudraCT No: 2006-006544-66
Study First Received: November 27, 2006
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Lux Biosciences, Inc.:
uveitis
calcineurin

Additional relevant MeSH terms:
Panuveitis
Uveitis
Chorioretinitis
Uveitis, Intermediate
Uveitis, Posterior
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases

ClinicalTrials.gov processed this record on August 20, 2014