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Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

Primary Purpose

Noninfectious Uveitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LX211
Sponsored by
Lux Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Noninfectious Uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LX211

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2010
Last Updated
January 8, 2013
Sponsor
Lux Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01243983
Brief Title
Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lux Biosciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noninfectious Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LX211
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LX211
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Daily mean systemic corticosteroid dose used during Weeks 12-24
Time Frame
Weeks 12-24
Title
Time to augmentation with corticosteroid therapy.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddy Anglade, M.D.
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Chair
Facility Information:
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
City
Ellsworth
State/Province
Maine
ZIP/Postal Code
04605
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
City
Vienna
ZIP/Postal Code
1030
Country
Austria
City
Recife
ZIP/Postal Code
50070-040, PE
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
21941-913, RJ
Country
Brazil
City
São Paulo
ZIP/Postal Code
04023-062, SP
Country
Brazil
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
City
Angers
ZIP/Postal Code
49933
Country
France
City
Bordeaux
ZIP/Postal Code
33000
Country
France
City
Paris
ZIP/Postal Code
75013
Country
France
City
Paris
ZIP/Postal Code
75019
Country
France
City
Münster
ZIP/Postal Code
48145
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Parma
ZIP/Postal Code
43126
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Birmingham
ZIP/Postal Code
B18 7QU
Country
United Kingdom
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

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Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

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