Safety and Efficacy Study of Gevokizumab to Treat Non-inf... | NCT01747538

Studies
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

NCT01747538

Sponsor

XOMA (US) LLC

Status

Terminated

Last Update Posted

Jul 12, 2016Estimated

Enrollment

281Actual

Phase

Phase 3

Conditions

Uveitis

Interventions

Placebo
Dose 1 gevokizumab
Dose 2 gevokizumab

Countries

United States
Argentina
Armenia
Australia
Brazil
Canada
China
France
Germany
Greece
Israel
Italy
Mexico
Poland
Portugal
Russia
South Africa
Spain
Taiwan
Tunisia
Turkey (Türkiye)
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2012-001609-25	EudraCT Number
U1111-1135-1462	Other Identifier	WHO

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Jun 2016Actual

Completion Date

Not provided

First Submitted Date

Dec 7, 2012

First Submission Date that Met QC Criteria

Dec 7, 2012

First Posted Date

Dec 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2016

Last Update Posted Date

Jul 12, 2016Estimated

Name	Class
Institut de Recherches Internationales Servier	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

281Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
Dose 1 gevokizumab	Experimental	Drug: Dose 1 gevokizumab
Dose 2 gevokizumab	Experimental	Drug: Dose 2 gevokizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Solution for subcutaneous injection	Placebo
Dose 1 gevokizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects with an occurrence of uveitic disease through Day 168		Day 0 through Day 168

Secondary Outcomes

Measure	Description	Time Frame
Time to first occurrence of uveitic disease		Day 0 through Day 168

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
Controlled uveitic disease in both eyes
Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
Effective contraceptive measures

Exclusion Criteria:

Infectious uveitis and masquerade syndromes
Isolated anterior uveitis
Contraindication to mydriatics
Active tuberculosis disease
History of allergic or anaphylactic reactions to monoclonal antibodies
History of recurrent infection or predisposition to infection; active ocular infection
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Facility	Status	City	State	ZIP	Country	Contacts
		Chandler	Arizona		United States

ID	Term
D014605	Uveitis
D015867	Uveitis, Intermediate
D015866	Uveitis, Posterior
D015864	Panuveitis

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases