Non-infectious Intermediate, Posterior, or Pan- Uveitis MedDRA version: 17.0 Level: PT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 10015919 - Eye disorders MedDRA version: 17.0 Level: PT Classification code 10069034 Term: Tubulointerstitial nephritis and uveitis syndrome System Organ Class: 10038359 - Re
Conditions
Interventions
Product Name: Gevokizumab
Product Code: S78989
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gevokizumab
CAS Number:
Sponsors
XOMA (US) LLC
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to first occurence of uveitic disease, - Mean change from baseline BCVA at D168 - Proportion of subjects who reach zero corticosteroids without an occurence of uveitic disease - Ophthalmologic assessments (visual acuity, vitreous haze score, ...) - 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. -Safety measurements : from selection to the end of the trial. | — |
Countries
Argentina, Australia, Austria, Brazil, China, France, Germany, Greece, Hong Kong, Italy, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, Spain, Taiwan, Tunisia, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Studies Department
Institut de Recherches Internationales Servier
Outcome results
None listed