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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014