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Non-infectious UveitisPhase 3ENDURENCT01032915

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

A Phase 3 study testing AIN457 in people with Non-infectious Uveitis, run by Novartis Pharmaceuticals at 94 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-infectious Uveitis
What is being tested?
AIN457
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
94 sitesin 10 countries
Study dates
Feb 2010to Jun 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with quiescent chronic, non-infectious intermediate uveitis, posterior uveitis or panuveitis as evidenced by <1+ anterior chamber cell grade and <1+ vitreous haze in both eyes for at least 6 weeks prior to screening.
  • Requirement for either of the following immunosuppressive therapies at any time within the past 3 months for the treatment or prevention of uveitis which must not have been increased within the 6 weeks prior to screening:
  • Prednisone or equivalent ≥10 mg daily.
  • ≥1 periocular injection or ≥1 intravitreal corticosteroid injection (i.e. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening.)
  • Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate as monotherapy or in combination with or without steroids. (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study.)
  • Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator.

Who cannot join

  • Ocular concomitant conditions/disease
  • Patients with a primary diagnosis of Behcet's disease, anterior uveitis or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (i.e. Punctate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR.)
  • Patients with active, non-infectious intermediate, posterior or panuveitis in one or both eyes (≥1+ anterior chamber cells and /or ≥1+ vitreous haze.)
  • Patients receiving or that may require corticosteroids (prednisone or equivalent) ≥1 mg/kg/day to maintain quiescence of their intraocular inflammation.
  • Ocular treatments
  • Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening.
Show all 13Show fewer
  • Treatment with fluocinolone acetonide implant (Retisert®) in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months.
  • Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle.
  • Systemic conditions or treatments
  • Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening. No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial.
  • Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening.
  • Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening. No treatment with live or live-attenuated vaccines will be allowed during the course of the clinical trial.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

94 sites in 10 countries.

94 sites in 10 countries

United States24 sites

  • Novartis Investigative Site

    Arlington, Texas, 76012

  • Texas Retina Associates

    Arlington, Texas, 76012

  • Sall Research Medical Center

    Artesia, California, 90701

  • Novartis Investigative Site

    Artesia, California, 90704

  • Emory University

    Atlanta, Georgia, 30322

  • Novartis Investigative Site

    Atlanta, Georgia, 30322

  • Novartis Investigative Site

    Baltimore, Maryland, 21205-2005

  • The Wilmer Eye Institute

    Baltimore, Maryland, 21287

  • Charlotte Eye, Ear, Nose, and Throat Associates

    Belmont, North Carolina, 28012

  • Novartis Investigative Site

    Beverly Hills, California, 90211

  • Retina-Vitreous Assoc. Medical Group

    Beverly Hills, California, 90211

  • Massachusets Eye Research and Surgery Institution (MERSI)

    Cambridge, Massachusetts, 02142

  • Novartis Investigative Site

    Cambridge, Massachusetts, 02142

  • Novartis Investigative Site

    Charlotte, North Carolina, 28210

  • Houston Eye Associates

    Houston, Texas, 77025

  • Novartis Investigative Site

    Houston, Texas, 77025

  • Novartis Investigative Site

    Louisville, Kentucky, 40202

  • University of Louisville Opthamology

    Louisville, Kentucky, 40202

  • Novartis Investigative Site

    Portland, Oregon, 97239

  • OHSU, Casey Eye Institute

    Portland, Oregon, 97239

  • University of Washington

    Seattle, Washington, 98104

  • Novartis Investigative Site

    Seattle, Washington, 98195

  • Novartis Investigative Site

    Teaneck, New Jersey, 07666

  • The Cornea and Laser Institute and UMDNJ

    Teaneck, New Jersey, 07666

Other trials in United States

Spain13 sites

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barakaldo, 48903

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08028

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15705

  • Novartis Investigative Site

    Santiago de Compostela, 15705

  • Novartis Investigative Site

    Valencia, Valencia, 46026

  • Novartis Investigative Site

    Valencia, 46009

  • Novartis Investigative Site

    Valencia, 46014

Other trials in Spain

Germany10 sites

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Dessau, 06847

  • Novartis Investigative Site

    Dessau, D-06822

  • Novartis Investigative Site

    Essen, 45122

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Tübingen, 72076

Other trials in Germany

India10 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 010

  • Novartis Investigative Site

    Chandigarh, 160 012

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600006

  • Novartis Investigative Site

    Chennai, 600006

  • Novartis Investigative SIte

    Coimbatore, 641014

  • Novartis Investigative Site

    Hyderabad, Telangana, 500 034

  • Novartis Investigative Site

    Kolkata, 700 073

  • Novartis Investigative Site

    Madurai, Tamil Nadu, 625020

  • Novartis Investigative Site

    Madurai, 625020

  • Novartis Investigative Site

    New Delhi, 110 029

Other trials in India

Switzerland10 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Bern, 3012

  • Novartis Investigative Site

    Lausanne, CHE, 1004

  • Novartis Investigative Site

    Lausanne, Switzerland, 1003

  • Novartis Investigative Site

    Lausanne, 1003

  • Novartis Investigative Site

    Lausanne, 1004

  • Novartis Investigative Site

    Lucerne, 6000

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Zurich, Switzerland, 8063

  • Novartis Investigative Site

    Zurich, 8063

Other trials in Switzerland

Italy8 sites

  • Novartis Investigative Site

    Ancona, 60126

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, 20132

  • Novartis Investigative Site

    Milan, 20157

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Parma, 43100

  • Novartis Investigative Site

    Roma, RM, 00100

  • Novartis Investigative Site

    Roma, 00100

Other trials in Italy

United Kingdom7 sites

  • Novartis Investigative Site

    Birmingham, B18 7QU

  • Novartis Investigative Site

    Bristol, BD1 2LX

  • Novartis Investigative Site

    Bristol, BS1 2LX

  • Novartis Investigative Site

    Liverpool, L7 8XP

  • Novartis Investigative Site

    London, EC1V 2PD

  • Novartis Investigative Site

    London, SE1 7EH

  • Novartis Investigative Site

    York, YO31 8HE

Other trials in United Kingdom

Brazil5 sites

  • Novartis Investigative Site

    Rio de Janeiro, 21941-590

  • Novartis Investigative Site

    São Paulo, São Paulo, 04023-900

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

  • Novartis Investigative Site

    São Paulo, 04040-002

  • Novartis Investigative Site

    São Paulo, 05403-000

Other trials in Brazil

Israel4 sites

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 5262100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, 06490

  • Novartis Investigative Site

    Fatih / Istanbul, 34098

  • Novartis Investigative Site

    Istanbul, 34390

Other trials in Turkey (Türkiye)

About this study

Official title: A 24 Week Multi-center, 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.

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppression.

Being tested
AIN457, Placebo
Keywords
Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
Medical subject headings
Uveitis, Intermediate, Panuveitis, Uveitis, Posterior, Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIN457Biological

    AIN457 300mg s.c weekly for 3 weeks then every 2 weeks

  • AIN457Biological

    AIN457 300mg s.c at baseline and Week 2 then every 4 weeks

  • AIN457Biological

    AIN457 150mg s.c at baseline and Week 2 then every 4 weeks

  • PlaceboDrug

    Placebo s.c weekly for 3 weeks then every 2 weeks

Study groups in NCT01032915
Study groupRoleWhat they receive
AIN457 300mg s.c weekly for 3 weeksExperimentalAIN457 300mg s.c weekly for 3 weeks then every 2 weeks
Receives: Biological: AIN457
AIN457 300mg s.c at baseline and Week 2ExperimentalAIN457 300mg s.c at baseline and Week 2 then every 4 weeks
Receives: Biological: AIN457
AIN457 150mg s.c at baseline and Week 2ExperimentalAIN457 150mg s.c at baseline and Week 2 then every 4 weeks
Receives: Biological: AIN457
Placebo s.c weekly for 3 weeksPlacebo comparatorPlacebo s.c weekly for 3 weeks then every 2 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to 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 baselineRecurrence of active intermediate, posterior, or panuveitis 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 of ≥ 10 ETDRS letters

    Measured: Baseline to 24 weeks

Secondary outcomes (3)

  1. Change (Reduction) From Baseline in Composite Immunosuppressive Medication Score (IMS) From Baseline to 24 Weeks

    Participants could have received up to 5 immunosuppresive agents (prednisone, cyclosporine, azathioprine, methotrexate, mycophenolate). Immunosuppressive Medication Score (IMS) is a combined, single numeric score derived on basis of total daily dose of specific immunosuppressive agents / unit body weight, ranged on a scale from 0-9 for the total daily dose in mg per kg. Patients receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. 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 (or its reduction from baseline) showed better clinical outcome

    Measured: Baseline to 24 weeks

  2. Mean Change in Best Corrected Visual Acuity From Baseline

    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.

    Measured: Baseline to 24 weeks

  3. Mean Change in Vitreous Haze Grade From Baseline to 24 Weeks

    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

    Measured: Baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: Results of a planned interim analysis did not show significant effects for any of the 3 AIN dose regimens versus placebo on any primary or secondary endpoint

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01032915
Sponsor's protocol ID
CAIN457C2301
Other IDs
2009-014835-19, 2009
Acronym
ENDURE
Status last verified
Oct 2015
First submitted
14 Dec 2009
Last updated
5 Nov 2015
Data monitoring committee
Yes

Publications

  • Dick AD, Tugal-Tutkun I, Foster S, Zierhut M, Melissa Liew SH, Bezlyak V, Androudi S. Secukinumab in the treatment of noninfectious uveitis: results of three randomized, controlled clinical trials. Ophthalmology. 2013 Apr;120(4):777-87. doi: 10.1016/j.ophtha.2012.09.040. Epub 2013 Jan 3.

    PubMed 23290985

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AIN457 in people with Non-infectious Uveitis, run by Novartis Pharmaceuticals at 94 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States, Spain, Germany, India, Switzerland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01032915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.

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