Extension Study to Assess Safety and Efficacy of AIN457 i... | NCT01103024

Studies
Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

NCT01103024

Sponsor

Novartis

Status

Withdrawn

Last Update Posted

Sep 29, 2020Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Uveitis

Interventions

AIN457
AIN457
AIN457
Placebo

Countries

United States
Canada
Israel
Japan
Switzerland

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

ID	Type	Description	Link
2009-015509-38	EudraCT Number

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Core study in non-infectious active uveitis was terminated

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Apr 9, 2010

First Submission Date that Met QC Criteria

Apr 12, 2010

First Posted Date

Apr 13, 2010Estimated

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

Sep 24, 2020

Last Update Posted Date

Sep 29, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
AIN457 300mg s.c every 2 weeks	Experimental	Biological: AIN457
AIN457 300mg s.c every 4 weeks	Experimental	Biological: AIN457
AIN457 150mg s.c every 4 weeks	Experimental	Biological: AIN457
Placebo s.c every 2 weeks	Placebo Comparator	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AIN457	Biological		AIN457 300mg s.c every 2 weeks
AIN457

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of recurrence		baseline to 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in immunosuppressive medication score from core study baseline		baseline to 52 weeks
Time to recurrence after the initial induction of quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) by study treatment or rescue medication

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have completed the entire treatment period of the 28-week core study
Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before study treatment in the extension study

Exclusion Criteria:

Inability or unwillingness to undergo repeated subcutaneous injections
Inability to comply with study or follow-up procedures
Any medical or psychiatric condition which, in the investigator's opinion would preclude the participant from adhering to the protocol or completing the study per protocol
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS
They are using simultaneously double barrier or two acceptable methods of contraception
They are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing
They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing
Their career, lifestyle, or sexual orientation precludes intercourse with a male partner
Partners have been sterilized by vasectomy or other reliable means

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

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Texas Retina Associates		Arlington	Texas	76012	United States
Novartis Investigative Site

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

ID	Term
D014603	Uveal Diseases
D005128	Eye Diseases