A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis (LUMINATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00404885
First received: November 27, 2006
Last updated: June 21, 2012
Last verified: June 2012

November 27, 2006
June 21, 2012
January 2007
November 2008   (final data collection date for primary outcome measure)
anterior chamber cells [ Time Frame: 16 and 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00404885 on ClinicalTrials.gov Archive Site
  • BCVA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • macular thickness [ Time Frame: 16 and 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Multi-center Study to Assess the Efficacy and Safety of LX211 in Active Non-infectious Anterior Uveitis
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 Anterior Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Uveitis, Anterior
  • Panuveitis
  • Drug: Placebo
    PO BID
  • Drug: LX211
    0.2 mg/kg, twice a day (BID)
  • Drug: LX211
    0.4 mg/kg, twice a day (BID)
  • Drug: LX211
    0.6 mg/kg, twice a day (BID)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: LX211, 0.2 mg/kg
    Intervention: Drug: LX211
  • Active Comparator: LX211, 0.4 mg/kg
    Intervention: Drug: LX211
  • Active Comparator: LX211, 0.6 mg/kg
    Intervention: Drug: LX211
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
May 2009
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented history of non-infectious anterior, anterior and intermediate- or panuveitis
  • Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated.
  • Grade of 2+ or higher for anterior chamber cells at time of enrollment
  • Considered by the investigator to require corticosteroid-sparing therapy.
  • Subjects not planning to undergo elective ocular surgery during the study

Exclusion Criteria:

  • Uveitis of infectious etiology
  • Presence of an ocular toxoplasmosis scar
  • An immune suppression regimen that includes an alkylating agent within the previous 90 days
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India,   United States,   Germany,   United Kingdom,   France,   Austria,   Canada
 
NCT00404885
LX211-03-UV, EudraCT No: 2006-006545-13
Yes
Lux Biosciences, Inc.
Lux Biosciences, Inc.
Not Provided
Study Chair: Eddy Anglade, M.D. Chief Medical Officer
Lux Biosciences, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP