NCT01090310

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3

Geographic Reach
8 countries

35 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

January 14, 2016

Completed
Last Updated

January 14, 2016

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

March 18, 2010

Results QC Date

February 12, 2015

Last Update Submit

December 8, 2015

Conditions

Non-infectious Uveitis

Keywords

Quiescent uveitisintermediate uveitispanuveitisposterior uveitisuveitisNVS 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 diseasesPsoriasis, inflammatory skin disease, scaly patches

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline to 52 weeks

Secondary Outcomes (4)

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

    Baseline to 52 weeks

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

    Baseline to 52 weeks

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

    Baseline to 52 weeks

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

    Baseline to 52 weeks

Study Arms (4)

AIN457 300mg every 2 weeks

EXPERIMENTAL

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

Drug: AIN457

AIN457 300 mg every 4 weeks

EXPERIMENTAL

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

Drug: AIN457

AIN457 150 mg every 4 weeks

EXPERIMENTAL

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

Drug: AIN457

Placebo

PLACEBO COMPARATOR

Placebo s.c. every 2 weeks

Drug: Placebo

Interventions

AIN457DRUG

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

AIN457 150 mg every 4 weeksAIN457 300 mg every 4 weeksAIN457 300mg every 2 weeks
PlaceboDRUG

Matching placebo to AIN457

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have completed the entire treatment period of the 24 week core study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Novartis Investigative Site

Beverly Hills, California, 90211, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30322, United States

Location

Novartis Investigative Site

Louisville, Kentucky, 40202, United States

Location

Novartis Investigative Site

Baltimore, Maryland, 21205-2005, United States

Location

Novartis Investigative Site

Cambridge, Massachusetts, 02142, United States

Location

Novartis Investigative Site

Teaneck, New Jersey, 07666, United States

Location

Novartis Investigative Site

Charlotte, North Carolina, 28210, United States

Location

Novartis Investigative Site

Portland, Oregon, 97239, United States

Location

Novartis Investigative Site

Arlington, Texas, 76012, United States

Location

Novartis Investigative Site

Houston, Texas, 77025, United States

Location

Novartis Investigative Site

São Paulo, São Paulo, 04023-900, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 05403-000, Brazil

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Kiel, 24105, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

New Delhi, 110 029, India

Location

Novartis Investigative Site

Jerusalem, 9112001, Israel

Location

Novartis Investigative Site

Petah Tikva, 49100, Israel

Location

Novartis Investigative Site

Ramat Gan, 5266202, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08036, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15705, Spain

Location

Novartis Investigative Site

Madrid, Madrid, 28040, Spain

Location

Novartis Investigative Site

Lausanne, CHE, 1004, Switzerland

Location

Novartis Investigative Site

Lausanne, Switzerland, 1003, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Bern, 3012, Switzerland

Location

Novartis Investigative Site

Lucerne, 6000, Switzerland

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Zurich, 8063, Switzerland

Location

Novartis Investigative Site

Birmingham, B18 7QU, United Kingdom

Location

Novartis Investigative Site

Liverpool, L7 8XP, United Kingdom

Location

Novartis Investigative Site

London, SE1 7EH, United Kingdom

Location

Novartis Investigative Site

York, YO31 8HE, United Kingdom

Location

MeSH Terms

Conditions

Uveitis, IntermediatePanuveitisUveitis, PosteriorUveitisMyocardial InfarctionCardiovascular DiseasesPsoriasisDermatitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesMyocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 19, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 14, 2016

Results First Posted

January 14, 2016

Record last verified: 2015-12

Locations

ES(4)IL(4)CH(7)GB(4)IN(1)BR(2)US(10)DE(3)