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OpenTrials
Completed

NCT Number: NCT01243983

Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

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).

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Key information

Conditions

Noninfectious Uveitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LX211

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Lux Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2010
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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