Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

Noninfectious Uveitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243983
• Other study ID #: LX211-11
• Secondary ID: 2010-022128-63
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2010
• Last updated: January 8, 2013
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Lux Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Noninfectious Uveitis
• Uveitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lux Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Brazil,  Canada,  Czech Republic,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Daily mean systemic corticosteroid dose used during Weeks 12-24		Weeks 12-24	Yes
Secondary	Time to augmentation with corticosteroid therapy.		Week 24	Yes