Efficacy and Safety Study of Gevokizumab to Treat Behcet'... | NCT02258867

Studies
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis

NCT02258867

Sponsor

XOMA (US) LLC

Status

Terminated

Last Update Posted

Dec 29, 2015Estimated

Enrollment

4Actual

Phase

Phase 3

Conditions

Behcet's Disease Uveitis

Interventions

Placebo
Gevokizumab

Countries

United States

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

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

Nov 2014

Primary Completion Date

Oct 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Oct 2, 2014

First Submission Date that Met QC Criteria

Oct 2, 2014

First Posted Date

Oct 8, 2014Estimated

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

Dec 28, 2015

Last Update Posted Date

Dec 29, 2015Estimated

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 objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Gevokizumab	Experimental		Drug: Gevokizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Solution for subcutaneous injection	Placebo
Gevokizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first ocular exacerbation	Time to first ocular exacerbation is defined as the number of days from randomization to the first ocular exacerbation.	Randomization through Day 280

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have characteristics of Behcet's disease consistent with International Criteria for Behcet's disease
Have a documented history of active uveitis with or without retinal vasculitis within the past 12 months
Best corrected visual acuity (BCVA) >= 20 ETDRS letters in both eyes at baseline
Effective contraceptive measures

Exclusion Criteria:

Infectious uveitis and masquerade syndromes
End stage ocular disease
History of allergic or anaphylactic reactions to monoclonal antibodies
Active tuberculosis disease
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

Condition Browse Module

MeSH Terms

ID	Term
D014605	Uveitis
D001528	Behcet Syndrome

Ancestor Terms

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C547697	gevokizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Santa Ana	California		United States