Efficacy and safety of gevokizumab in the treatment of patients with active non-infectious uveitis.

Phase 1

• Conditions: on-infectious Intermediate, Posterior, or Pan- Uveitis; MedDRA version: 17.0Level: PTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10069034Term: Tubulointerstitial nephritis and uveitis syndromeSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 17.0Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862; MedDRA version: 17.0Level: LLTClassification code 10066681Term: Acute uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: LLTClassification code 10071139Term: Behcet's uveitisSystem Organ Class: 100000004866; MedDRA version: 17.0Level: LLTClassification code 10042745Term: Sympathetic uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10012692Term: Diabetic uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 17.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2012-001610-42-GB
• Lead Sponsor: XOMA (US) LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-25
• Last Update Posted: 26 November 2018

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
- Active uveitic disease, defined by the presence of = 2+ vitreous haze score in at least one eye
- Best Corrected Visual Acuity of at least 10 letters in the study eye
- Patients with a stable background treatment of oral corticosteroids, selected immunosuppressive therapy, or combination of both.
- 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 the non-study eye or monocular vision
- Presence of severe cataract or severe posterior capsular opacification.
- Contraindication to mydriatics or presence of posterior synechiae.
- 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 the treatment of subjects with active non infectious intermediate, posterior, or pan- uveitis.;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 responders at D56;Timepoint(s) of evaluation of this end point: From inclusion to D56.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Proportions of responders at D28,<br>- Proportion at responders at other visits,<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.