Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2012

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

Arms, Groups and Cohorts

  • Experimental: LX211
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary 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.
    • Time Frame: 12 weeks

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lux Biosciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eddy Anglade, M.D., Study Chair, Chief Medical Officer

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