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Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

NCT01243983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2013-01-10

No results posted yet for this study

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).

Conditions

  • Noninfectious Uveitis

Interventions

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

Sponsors & Collaborators

  • Lux Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Eddy Anglade, M.D. · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States
  • Austria
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01243983 on ClinicalTrials.gov