Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis - Clinical Trial for Non-infectious Uveitis | NCT01090310

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AIN457

Placebo

About this trial

This is an interventional treatment trial for Non-infectious Uveitis focused on measuring Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis, NVS Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database., Avoid acronyms, abbreviations and trade names., Examples: Heart failure, aliskiren, heart attack, cardiovascular diseases, Psoriasis, inflammatory skin disease, scaly patches

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who have completed the entire treatment period of the 24 week core 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 wouldpreclude the participant from adhering to the protocol or completing the study per protocol.

Other protocol-defined inclusion/exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

AIN457 300mg every 2 weeks

AIN457 300 mg every 4 weeks

AIN457 150 mg every 4 weeks

Placebo

Arm Description

AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks

AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

Placebo s.c. every 2 weeks

Outcomes

Primary Outcome Measures

The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline

Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension

Secondary Outcome Measures

Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value

The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks

Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension

The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score

Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies

Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4

Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension

IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.

Full Information

NCT ID

NCT01090310

First Posted

March 18, 2010

Last Updated

December 8, 2015

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01090310

Brief Title

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

Acronym

ENDURE

Official Title

A 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Systemic Immunosuppression in Patients With Quiescent, Non-infectious Intermediate, Posterior or Panuveitis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Terminated

Study Start Date

August 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-infectious Uveitis

Keywords

Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis, NVS Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database., Avoid acronyms, abbreviations and trade names., Examples: Heart failure, aliskiren, heart attack, cardiovascular diseases, Psoriasis, inflammatory skin disease, scaly patches

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIN457 300mg every 2 weeks

Arm Type

Experimental

Arm Description

AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks

Arm Title

AIN457 300 mg every 4 weeks

Arm Type

Experimental

Arm Description

AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

Arm Title

AIN457 150 mg every 4 weeks

Arm Type

Experimental

Arm Description

AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo s.c. every 2 weeks

Intervention Type

Drug

Intervention Name(s)

AIN457

Intervention Description

AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo to AIN457

Primary Outcome Measure Information:

Title

The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline

Description

Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension

Time Frame

Baseline to 52 weeks

Secondary Outcome Measure Information:

Title

Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value

Description

The changes in steps (0, 1, or >= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (<1+ anterior chamber cell grade and <1+ vitreous haze) for at least 2 weeks

Time Frame

Baseline to 52 weeks

Title

Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension

Description

The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score

Time Frame

Baseline to 52 weeks

Title

Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies

Description

Evaluation of recurrence until resolution is ascertained, based on the first criteria (a >2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4

Time Frame

Baseline to 52 weeks

Title

Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension

Description

IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment & baseline IMS as covariate, where the lower IMS showed better clinical outcome.

Time Frame

Baseline to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients who have completed the entire treatment period of the 24 week core 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 wouldpreclude the participant from adhering to the protocol or completing the study per protocol. Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205-2005

Country

United States

Facility Name

Novartis Investigative Site

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02142

Country

United States

Facility Name

Novartis Investigative Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novartis Investigative Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

Country

United States

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

SP

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

SP

ZIP/Postal Code

04023-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Novartis Investigative Site

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Novartis Investigative Site

City

New Delhi

ZIP/Postal Code

110 029

Country

India

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

5266202

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel-Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15705

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Lausanne

State/Province

CHE

ZIP/Postal Code

1004

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3012

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1003

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Luzern

ZIP/Postal Code

6000

Country

Switzerland

Facility Name

Novartis Investigative Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zuerich

ZIP/Postal Code

8063

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B18 7QU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

York

ZIP/Postal Code

YO31 8HE

Country

United Kingdom

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis (ENDURE)

Non-infectious Uveitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial