A Multi-center, Double-Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects with Active Non-Infectious Intermediate, Posterior or Pan-uveitis - A MC study to assess Efficacy and Safety of Voclosporin in Panuveitis

Phase 1

• Conditions: on-Infectious Intermediate, Posterior or Pan-uveitis

• Registration Number: EUCTR2010-022128-63-GB
• Lead Sponsor: ux Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

I.1.Active noninfectious uveitis involving the intermediate and/or posterior segment (anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at Baseline visit (Visit 1).
I.2.Uveitis therapy
Current therapy must conform to one of the following:
-Prednisone monotherapy at a dose of = 10 mg/day and = 40 mg/day (or equivalent) for at least 2 weeks prior to baseline visit (Visit 1)
-Prednisone, at any dose, in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to baseline visit (Visit 1)
-N.B.: All immunosuppressive therapy (excluding systemic corticosteroids) must be discontinued by the evening prior to the baseline visit (Visit 1).
I.3.Considered by the Investigator to require systemic immunosuppressive therapy
I.4.A minimum ability to count fingers at a distance of 30 cm (1 foot) in both eyes
I.5.At least 18 years of age
I.6.Subjects, whether male or female, with reproductive potential and who are sexually active must agree to use double-barrier contraception methods throughout the course of the study (minimum of 24 weeks)
I.7.Women of childbearing potential must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug. All female subjects (including those with tubal ligations) will be considered to be of childbearing potential unless one or more of the following criteria are met:
-Over the age of 60 years
-Amenorrheic for at least 2 years if age 45-60 years
-Have had a hysterectomy and/or bilateral oophorectomy
I.8.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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

E1.1.Uveitis limited to only the anterior segment in the study eye
E1.2.Confirmed or suspected infectious uveitis in either eye, including but not limited to infectious uveitis due to tuberculosis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipples disease, herpes zoster virus (HZV) and herpes simplex virus (HSV) or history of other ocular herpetic infection
E1.3.Presence of an ocular toxoplasmosis scar or suspected active infection in either eye
E1.4.Active infection (i.e. bacterial, viral, parasitic or fungal) in either eye
E1.5.Serpiginous choroidopathy in either eye
E1.6.Active inflammatory lesions or vasculitis involving the central macula in either eye
E1.7.History of central serous chorioretinopathy in either eye
E1.8.Proliferative or severe non-proliferative diabetic retinopathy in either eye
E1.9.Neovascular/wet age-related macular degeneration in either eye
E1.10.Abnormality of vitreoretinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) thought by the Investigator to interfere with measurement of macular thickness or with the potential for macular structural damage independent of the inflammatory process in the study eye
E1.11.Clinically suspected or confirmed ocular or central nervous system lymphoma
E1.12.Lens opacities or obscured ocular media in the study eye (refer to section 8.1 for definition of the study eye) at baseline (Visit 1) such that reliable evaluations and grading of either the intermediate or posterior segment cannot be performed
E1.13.Any other ocular disease in the study eye that can interfere with the diagnosis or assessment of disease progression
E1.14.Monocular [anophthalmic fellow eye]
E1.15.Intraocular pressure of >21 mmHg in either eye
E1.16.Chronic hypotony (intraocular pressure less than 6 mmHg or clinical signs such as choroidals, choroidal or corneal folds) or pre-phthisical state (e.g., sclera thickening on ultrasonography, decreasing globe size) in either eye
E1.17.Contraindication to pupil dilation in either eye
E1.18.Unwillingness to defer elective ocular surgery (e.g., cataract extraction) until after completion of study participation in the study eye.
E2. Specific Prior and Current Treatments (for details please refer to protocol)
E3. Specific Extra-ocular Conditions (for details please refer to protocol)
E4. Specific Laboratory, Blood Pressure and ECG Evaluations (for details please refer to protocol)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: The secondary objective of this study is to assess the relationship of voclosporin exposure to efficacy and safety parameters.;Primary end point(s): Mean change from baseline in graded vitreous haze in the study eye at 12 weeks of therapy or at time of treatment failure, if earlier.