Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

Lux Biosciences

Status and phase: Completed; Phase 3

Conditions: Noninfectious Uveitis

Treatments: Drug: LX211

Study type: Interventional

Funder types: Industry

Identifiers

NCT01243983

2010-022128-63 (EudraCT Number)

LX211-11

Details and patient eligibility

About

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).

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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155 participants in 2 patient groups, including a placebo group

LX211

Experimental group

Treatment:

Drug: LX211

Placebo

Placebo Comparator group

Treatment:

Drug: LX211