A Phase 3 interventional study of LX211 in Noninfectious Uveitis, sponsored by Lux Biosciences, Inc.. Completed at 52 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by Lux Biosciences, Inc. · Phase 3, Interventional, and Treatment
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).
Lux Biosciences, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Subjects must be:
Exclusion Criteria:
The following conditions are exclusionary if present:
Prior and Current Treatment:
- As defined in the protocol
Extraocular Conditions:
- As defined in the protocol.
Laboratory, Blood Pressure and ECG Evaluations:
Drug: 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
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
Daily mean systemic corticosteroid dose used during Weeks 12-24
Time frame: Weeks 12-24
Time to augmentation with corticosteroid therapy.
Time frame: Week 24
The record gives a start of Feb 2011, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Voclosporin
Lux Biosciences, Inc.