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

October 9, 2012 updated by: Lux Biosciences, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Universitätsklinik für Augenheilkunde
      • Wien, Austria
        • Klinik für Augenheilkunde, Dept. of Ophthalmology
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Ivey Eye Institute
      • Ottawa, Ontario, Canada, K1H 8L6
        • University of Ottawa Eye Institute
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Health Center
  • France
      • Angers, France
        • Center Hospitalier Universitaire d' Angers, Service d'Opthalmologie
      • Paris, France
        • Hôpital Pitié Salpétrière, Service d'Ophtalmologie
  • Germany
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Heidelberg, Germany
        • Augenklinik der Universität Heidelberg
      • Tübingen, Germany
        • Universitätsklinikum Tübingen
  • India
      • Bangalore, India
        • Vittala International Institute of Ophthalmology
      • Chandigarh, India
        • Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)
      • Coimbatore, India
        • Aravind Eye Hospital, Uvea Clinic
      • Mumbai, India
        • Aditya Jyot Eye Hospital Pvt Ltd
      • New Delhi, India
        • Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences
    • Andhra Pradesh
      • Hyderabaad, Andhra Pradesh, India
        • L V Prasad Eye Institute
    • Orissa
      • Bhubaneswar, Orissa, India
        • Consultant, Retina and Vitreous Services, Bhubaneswar L V Prasad Eye Institute
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Department of Opthalmology, Sankara Nethralaya, Medical Research Foundation,
      • Madurai, Tamil Nadu, India
        • Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Eye Hospital and University of Bristol
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • London, United Kingdom
        • Moorfields Eye Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois - Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Midwest Eye Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
      • Cambridge, Massachusetts, United States, 02142
        • Massachusetts Eye Research and Surgery Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Associated Retinal Consultants, PC
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ-New Jersey Medical School, Ophthalmology Dept.
    • New York
      • New York, New York, United States, 10003
        • New York Eye & Ear Hospital
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Eye Center, Erwin Road
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates
      • Houston, Texas, United States, 77030
        • Vitreoretinal Consultants
      • San Antonio, Texas, United States, 78240
        • Retina & Uveitis Consultants of Texas
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Viginia Eye Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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)
Drug: LX211
0.4 mg/kg, twice a day (BID)
Drug: LX211
0.6 mg/kg, twice a day (BID)
ACTIVE_COMPARATOR: LX211, 0.4 mg/kg
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)
ACTIVE_COMPARATOR: LX211, 0.6 mg/kg
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
vitreous haze
Time Frame: 16 and 24 weeks
16 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
BCVA
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lux Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

November 27, 2006

First Submitted That Met QC Criteria

November 27, 2006

First Posted (ESTIMATE)

November 29, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 9, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LX211-01-UV
  • EudraCT No: 2006-006543-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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