Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis - Full Text View

Sponsor:	Lux Biosciences, Inc.
Information provided by:	Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT01243983

Purpose

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 ocular segments. The secondary objective of this study is to assess the relationship of voclosporin exposure to efficacy and safety parameters.

Condition	Intervention	Phase
Noninfectious Uveitis	Drug: LX211	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3 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

Further study details as provided by Lux Biosciences, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Daily mean systemic corticosteroid dose used during Weeks 12-24 [ Time Frame: Weeks 12-24 ] [ Designated as safety issue: Yes ]
Time to augmentation with corticosteroid therapy. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	December 2010
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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
Placebo Comparator: Placebo	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243983

Contacts

Contact: Eddy Anglade, MD

201-946-0223

eddy.anglade@luxbio.com

Show 36 Study Locations

Sponsors and Collaborators

Lux Biosciences, Inc.

Investigators

Study Chair:

Eddy Anglade, M.D.

Chief Medical Officer

More Information

No publications provided

Responsible Party:	Eddy Anglade, Chief Medical Officer, Lux Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT01243983 History of Changes
Other Study ID Numbers:	LX211-11, 2010-022128-63
Study First Received:	November 17, 2010
Last Updated:	May 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Uveitis
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2012