NCT01103024

Brief Summary

The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.

Trial Health

37
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_3

Geographic Reach
5 countries

11 active sites

Status
withdrawn

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

April 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

April 9, 2010

Last Update Submit

September 24, 2020

Conditions

Uveitis

Keywords

Active uveitisintermediate uveitispanuveitisposterior uveitisuveitis

Outcome Measures

Primary Outcomes (1)

  • Rate of recurrence

    baseline to 52 weeks

Secondary Outcomes (5)

  • 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

    baseline to 52 weeks

  • Mean change in best corrected visual acuity from baseline

    baseline to 52 weeks

  • Change from baseline in Quality of Life/Patient reported outcome assessments

    baseline to 52 weeks

  • Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks

    baseline to 52 weeks

Study Arms (4)

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

AIN457BIOLOGICAL
AIN457 300mg s.c every 2 weeks
PlaceboBIOLOGICAL
Placebo s.c every 2 weeks

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 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

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Novartis Investigative Site

London, Ontario, Canada

Location

Novartis Investigative Site

North York, Ontario, Canada

Location

Novartis Investigative Site

Ramat Gan, 52621, Israel

Location

Novartis Investigative Site

Bunkyō City, Japan

Location

Novartis Investigative Site

Fukuoka, Japan

Location

Novartis Investigative Site

Fukushima, Japan

Location

Novartis Investigational Site

Kyoto, 602-0841, Japan

Location

Novartis Investigative Site

Sapporo, Japan

Location

Novartis Investigative Site

Tochigi, Japan

Location

Novartis Investigative Site

Bern, Switzerland

Location

MeSH Terms

Conditions

UveitisUveitis, IntermediatePanuveitisUveitis, Posterior

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR
0

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

April 9, 2010

First Posted

April 13, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

CA(2)CH(1)JP(6)US(1)IL(1)