Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01243983

Enrollment

155

Registered

2010-11-19

Start date

2011-02-28

Completion date

2012-12-31

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Noninfectious Uveitis

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).

Interventions

DRUGLX211

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Daily mean systemic corticosteroid dose used during Weeks 12-24	Weeks 12-24
Time to augmentation with corticosteroid therapy.	Week 24

Countries

Austria, Brazil, Canada, Czechia, France, Germany, Italy, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026