Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00404612
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Lux Biosciences, Inc.

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

Condition or disease Intervention/treatment Phase
Uveitis, Posterior Uveitis, Intermediate Panuveitis Drug: Placebo Drug: LX211 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. vitreous haze [ Time Frame: 16 and 24 weeks ]

Secondary Outcome Measures :
  1. BCVA [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00404612


  Show 41 Study Locations
Sponsors and Collaborators
Lux Biosciences, Inc.
Investigators
Layout table for investigator information
Study Chair: Eddy Anglade, M.D. Chief Medical Officer

Additional Information:
Layout table for additonal information
Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00404612     History of Changes
Other Study ID Numbers: LX211-01-UV
EudraCT No: 2006-006543-31
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Lux Biosciences, Inc.:
uveitis
calcineurin
Additional relevant MeSH terms:
Layout table for MeSH terms
Uveitis
Panuveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroiditis
Choroid Diseases