Efficacy and safety of gevokizumab in the treatment of patients with active non-infectious uveitis currently controlled with systemic treatment

• Conditions: on-infectious Intermediate, Posterior, or Pan- Uveitis; MedDRA version: 14.1Level: PTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10069034Term: Tubulointerstitial nephritis and uveitis syndromeSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 14.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10071139Term: Behcet's uveitisSystem Organ Class: 100000004870; MedDRA version: 14.1Level: LLTClassification code 10042745Term: Sympathetic uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10012692Term: Diabetic uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-001609-25-GR
• Lead Sponsor: XOMA (US) LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-14
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- Diagnosis of non-infectious intermediate, posterior, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria ([SUN] criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history
- Controlled uveitic disease in both eyes, defined by no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber cell grade = 0.5+ according to SUN criteria, Vitrous Haze grade = 0.5+ according to the SUN/NEI Scoring for Vitrous Haze,
- Best Corrected Visual Acuity of 35 letters or more in both eyes,
- Patients with a stable dose of oral corticosteroids, alone or in combination with selected stable immunosuppressive therapy .
- Male or female, age =18 (or legal age of majority in the country) at selection
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures.
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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Infectious uveitis and masquerade syndromes
- Isolated anterior uveitis
- Best corrected visual acuity < 35 letters in both eyes or monocular vision
- Presence of severe cataract or severe posterior capsular opacification.
- Contraindication to mydriatics or presence of posterior synechiae, in either eye.
- Active TB disease.
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- History of malignancy within 5 years prior to Selection.
- Infectious disease.
- Known immunodeficiency.
- Pregnancy, breastfeeding or possibility to become pregnant during the study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to demonstrate the superiority of gevokizumab compared to placebo in reducing the risk of recurrent uveitic disease in subjects with non-infectious intermediate, posterior, or pan- uveitis currently controlled with systemic treatment. ;Secondary Objective: The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety.;Primary end point(s): Proportion of subjects with an occurence of uveitic disease ;Timepoint(s) of evaluation of this end point: From inclusion to D168

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Time to first occurence of uveitic disease,<br>- Mean change from baseline BCVA at D168<br>- Proportion of subjects who reach zero corticosteroids without an occurence of uveitic disease <br>- Ophthalmologic assessments (visual acuity, vitreous haze score, ...)<br>- Safety measurements (adverse events, optical coherence tomography, intraocular pressure, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters,...) ;Timepoint(s) of evaluation of this end point: -Ophthalmologic endpoints: at each visit until D168, and at D280, D392, OL-0, OL-112, and OL-224.<br>-Safety measurements : from selection to the end of the trial.