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Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01243983
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Noninfectious Uveitis Drug: LX211 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

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



Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Daily mean systemic corticosteroid dose used during Weeks 12-24 [ Time Frame: Weeks 12-24 ]
  2. Time to augmentation with corticosteroid therapy. [ Time Frame: Week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243983


  Show 52 Study Locations
Sponsors and Collaborators
Lux Biosciences, Inc.
Investigators
Study Chair: Eddy Anglade, M.D. Chief Medical Officer
More Information

Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01243983     History of Changes
Other Study ID Numbers: LX211-11
2010-022128-63 ( EudraCT Number )
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases