Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis
NCT ID: NCT01243983
Last Updated: 2013-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
155 participants
INTERVENTIONAL
2011-02-28
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LX211
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
Placebo
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Lux Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eddy Anglade, M.D.
Role: STUDY_CHAIR
Chief Medical Officer
Locations
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Peoria, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Mountain View, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Torrance, California, United States
Indianapolis, Indiana, United States
Ellsworth, Maine, United States
Baltimore, Maryland, United States
Cambridge, Massachusetts, United States
Newark, New Jersey, United States
Belmont, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Dublin, Ohio, United States
Middleburg Heights, Ohio, United States
Ashland, Oregon, United States
Philadelphia, Pennsylvania, United States
Ladson, South Carolina, United States
Arlington, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Vienna, , Austria
Recife, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Ottawa, Ontario, Canada
Brno, , Czechia
Hradec Králové, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Angers, , France
Bordeaux, , France
Paris, , France
Paris, , France
Münster, , Germany
Tübingen, , Germany
Bologna, , Italy
Milan, , Italy
Padua, , Italy
Parma, , Italy
Reggio Emilia, , Italy
Birmingham, , United Kingdom
London, , United Kingdom
London, , United Kingdom
York, , United Kingdom
Countries
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Other Identifiers
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2010-022128-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LX211-11
Identifier Type: -
Identifier Source: org_study_id
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