Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

NCT01243983 | Completed Phase 3 DMC

• 2 other identifiers: LX211-112010-022128-63
• Study Type: interventional
• Target: 155
• Locations: 9 countries
• Sites: 52

Brief Summary

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).

Conditions

Noninfectious Uveitis

Outcome Measures

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.

  12 weeks

Secondary Outcomes (2)

• Daily mean systemic corticosteroid dose used during Weeks 12-24

  Weeks 12-24

• Time to augmentation with corticosteroid therapy.

  Week 24

Study Arms (2)

LX211

EXPERIMENTAL

Drug: LX211

Placebo

PLACEBO COMPARATOR

Drug: LX211

Interventions

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

LX211; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Ocular Disease/Conditions
• 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.

Sponsors & Collaborators

• Lux Biosciences, Inc.: lead

Study Sites (52)

Unknown Facility

Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85014, United States

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Little Rock, Arkansas, 72205, United States

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Beverly Hills, California, 90211, United States

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Mountain View, California, 94040, United States

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Sacramento, California, 95819, United States

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Santa Ana, California, 92705, United States

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Torrance, California, 90503, United States

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Indianapolis, Indiana, 46290, United States

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Ellsworth, Maine, 04605, United States

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Baltimore, Maryland, 21287, United States

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Cambridge, Massachusetts, 02142, United States

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Newark, New Jersey, 07103, United States

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Belmont, North Carolina, 28012, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44122, United States

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Cleveland, Ohio, 44195, United States

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Dublin, Ohio, 43016, United States

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Middleburg Heights, Ohio, 44130, United States

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Ashland, Oregon, 97520, United States

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Philadelphia, Pennsylvania, 19107, United States

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Ladson, South Carolina, 29456, United States

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Arlington, Texas, 76012, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78240, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23219, United States

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Vienna, 1030, Austria

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Recife, 50070-040, PE, Brazil

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Rio de Janeiro, 21941-913, RJ, Brazil

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São Paulo, 04023-062, SP, Brazil

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Ottawa, Ontario, K1H 8L6, Canada

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Brno, 62500, Czechia

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Hradec Králové, 50005, Czechia

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Olomouc, 77520, Czechia

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Prague, 12808, Czechia

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Angers, 49933, France

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Bordeaux, 33000, France

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Paris, 75013, France

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Paris, 75019, France

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Münster, 48145, Germany

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Tübingen, 72076, Germany

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Bologna, 40138, Italy

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Milan, 20132, Italy

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Padua, 35128, Italy

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Parma, 43126, Italy

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Reggio Emilia, 42100, Italy

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Birmingham, B18 7QU, United Kingdom

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London, EC1V 2PD, United Kingdom

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London, SE1 7EH, United Kingdom

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York, YO31 8HE, United Kingdom

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Study Officials

• Eddy Anglade, M.D.

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

AU (1); US (28); CA (1); CZ (4); DE (2); BR (3); GB (4); IT (5); FR (4)