Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

A Multi-Center, Double-Masked, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects With Active Noninfectious Uveitis Involving the Intermediate and/or Posterior Segments of the Eye

The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior segments of the eye (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis).

Study Overview

• Status: Completed
• Conditions: Noninfectious Uveitis
• Intervention / Treatment: Drug: LX211

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1030
• Brazil
  • Recife, Brazil, 50070-040, PE
  • Rio de Janeiro, Brazil, 21941-913, RJ
  • São Paulo, Brazil, 04023-062, SP
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
• Czech Republic
  • Brno, Czech Republic, 62500
  • Hradec Kralove, Czech Republic, 50005
  • Olomouc, Czech Republic, 77520
  • Prague, Czech Republic, 12808
• France
  • Angers, France, 49933
  • Bordeaux, France, 33000
  • Paris, France, 75013
  • Paris, France, 75019
• Germany
  • Münster, Germany, 48145
  • Tübingen, Germany, 72076
• Italy
  • Bologna, Italy, 40138
  • Milano, Italy, 20132
  • Padova, Italy, 35128
  • Parma, Italy, 43126
  • Reggio Emilia, Italy, 42100
• United Kingdom
  • Birmingham, United Kingdom, B18 7QU
  • London, United Kingdom, EC1V 2PD
  • London, United Kingdom, SE1 7EH
  • York, United Kingdom, YO31 8HE
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
    • Phoenix, Arizona, United States, 85014
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
  • California
    • Beverly Hills, California, United States, 90211
    • Mountain View, California, United States, 94040
    • Sacramento, California, United States, 95819
    • Santa Ana, California, United States, 92705
    • Torrance, California, United States, 90503
  • Indiana
    • Indianapolis, Indiana, United States, 46290
  • Maine
    • Ellsworth, Maine, United States, 04605
  • Maryland
    • Baltimore, Maryland, United States, 21287
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
  • New Jersey
    • Newark, New Jersey, United States, 07103
  • North Carolina
    • Belmont, North Carolina, United States, 28012
    • Winston-Salem, North Carolina, United States, 27157
  • Ohio
    • Cleveland, Ohio, United States, 44195
    • Cleveland, Ohio, United States, 44122
    • Dublin, Ohio, United States, 43016
    • Middleburg Heights, Ohio, United States, 44130
  • Oregon
    • Ashland, Oregon, United States, 97520
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
  • South Carolina
    • Ladson, South Carolina, United States, 29456
  • Texas
    • Arlington, Texas, United States, 76012
    • Dallas, Texas, United States, 75231
    • Houston, Texas, United States, 77030
    • San Antonio, Texas, United States, 78240
  • Virginia
    • Norfolk, Virginia, United States, 23502
    • Richmond, Virginia, United States, 23219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Active noninfectious uveitis involving the intermediate and/or posterior segment (i.e., anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at the baseline visit. Subjects who also have anterior segment involvement need not be excluded if otherwise qualified.

• Subjects must be:

  • Capable of understanding the purpose and risks of the study.
  • Able to give written informed consent.
  • Able to comply with all study requirements.

Exclusion Criteria:

• Ocular Disease/Conditions

• The following conditions are exclusionary if present:

  • Uveitis limited to only the anterior segment of the study eye.
  • Confirmed or suspected infectious uveitis in either eye.

• Prior and Current Treatment:

  - As defined in the protocol

• Extraocular Conditions:

  - As defined in the protocol.

• Laboratory, Blood Pressure and ECG Evaluations:

  • As defined in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: LX211; Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio: Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d.; Treatment Arm B: placebo p.o. b.i.d. Dosage Form: • Soft gelatin capsule Duration of treatment: • 24 weeks
Experimental: LX211	Drug: LX211; Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio: Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d.; Treatment Arm B: placebo p.o. b.i.d. Dosage Form: • Soft gelatin capsule Duration of treatment: • 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at the time of treatment failure, if earlier.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Daily mean systemic corticosteroid dose used during Weeks 12-24	Weeks 12-24
Time to augmentation with corticosteroid therapy.	Week 24

Collaborators and Investigators

• Sponsor: Lux Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): January 10, 2013
• Last Update Submitted That Met QC Criteria: January 8, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: LX211-11; 2010-022128-63 (EudraCT Number)