Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01243983
First received: November 17, 2010
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Noninfectious Uveitis
Drug: LX211
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lux Biosciences, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily mean systemic corticosteroid dose used during Weeks 12-24 [ Time Frame: Weeks 12-24 ] [ Designated as safety issue: Yes ]
  • Time to augmentation with corticosteroid therapy. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: February 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243983

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

No publications provided

Responsible Party: Lux Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01243983     History of Changes
Other Study ID Numbers: LX211-11, 2010-022128-63
Study First Received: November 17, 2010
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on April 17, 2014