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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


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
See also
  Status Clinical Trial Phase
Terminated NCT03207815 - Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis Phase 2
Completed NCT01789320 - Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis Phase 1/Phase 2