Non-infectious UveitisPhase 3ENDURENCT01090310

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 35 sites in 8 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 extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing 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
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 35 sitesin 8 countries
Study dates: Aug 2010to Jul 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 who have completed the entire treatment period of the 24 week core study

Who cannot join

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.

Trial locations and contacts

35 sites in 8 countries.

Country

City, postcode or hospital

35 sites in 8 countries

United States10 sites

Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Atlanta, Georgia, 30322
Novartis Investigative Site
Baltimore, Maryland, 21205-2005
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Cambridge, Massachusetts, 02142
Novartis Investigative Site
Charlotte, North Carolina, 28210
Novartis Investigative Site
Houston, Texas, 77025
Novartis Investigative Site
Louisville, Kentucky, 40202
Novartis Investigative Site
Portland, Oregon, 97239
Novartis Investigative Site
Teaneck, New Jersey, 07666

Other trials in United States

Switzerland7 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
Lucerne, 6000
Novartis Investigative Site
Sankt Gallen, 9007
Novartis Investigative Site
Zurich, 8063

Other trials in Switzerland

Israel4 sites

Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Ramat Gan, 5266202
Novartis Investigative Site
Tel Aviv, 6423906

Other trials in Israel

Spain4 sites

Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
Madrid, Madrid, 28040
Novartis Investigative Site
Santiago de Compostela, Galicia, 15705

Other trials in Spain

United Kingdom4 sites

Novartis Investigative Site
Birmingham, B18 7QU
Novartis Investigative Site
Liverpool, L7 8XP
Novartis Investigative Site
London, SE1 7EH
Novartis Investigative Site
York, YO31 8HE

Other trials in United Kingdom

Germany3 sites

Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Tübingen, 72076

Other trials in Germany

Brazil2 sites

Novartis Investigative Site
São Paulo, São Paulo, 04023-900
Novartis Investigative Site
São Paulo, São Paulo, 05403-000

Other trials in Brazil

India1 site

Novartis Investigative Site
New Delhi, 110 029

Other trials in India

About this study

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

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

Conditions: Non-infectious Uveitis
Being tested: AIN457, Placebo
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
Medical subject headings: Uveitis, Intermediate, Panuveitis, Uveitis, Posterior, Uveitis, Myocardial Infarction, Cardiovascular Diseases, Psoriasis, Dermatitis

What participants receive

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

AIN457Drug
AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
PlaceboDrug
Matching placebo to AIN457

Study groups in NCT01090310
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Drug: AIN457
Placebo	Placebo comparator	Placebo s.c. every 2 weeks Receives: Drug: Placebo

What is being measured

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

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
Measured: Baseline to 52 weeks

Secondary outcomes (4)

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
Measured: Baseline to 52 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
Measured: 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
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
Measured: Baseline to 52 weeks
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.
Measured: Baseline to 52 weeks

Timeline

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

Aug 2010Jul 2011

First posted19 Mar 2010 (estimated)
Study startAug 2010
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-infectious UveitisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01090310
Sponsor's protocol ID: CAIN457C2301E1
Other IDs: 2009-015508-24, 2009
Acronym: ENDURE
Status last verified: Dec 2015
First submitted: 18 Mar 2010
Last updated: 14 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01090310
Acronym / sponsor ID: ENDURE / CAIN457C2301E1
Conditions: 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
Phase: Phase 3
Study type: Interventional
Recruitment status: Terminated
Enrolment: 86 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 19 Mar 2010 (estimated)
Results: Posted 14 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
AIN457 300mg every 2 weeks	Experimental	Drug: AIN457AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks
AIN457 300 mg every 4 weeks	Experimental	Drug: AIN457AIN457 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 every 4 weeks	Experimental	Drug: AIN457AIN457 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	Placebo comparator	Drug: PlaceboPlacebo s.c. every 2 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AIN457AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake	Drug	AIN457 150 mg every 4 weeks, AIN457 300 mg every 4 weeks, AIN457 300mg every 2 weeks
PlaceboMatching placebo to AIN457	Drug	Placebo

Primary outcome

The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline
Time frame: Baseline to 52 weeks
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

4 secondary outcomes

Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value
Time frame: Baseline to 52 weeks
Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension
Time frame: 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
Time frame: Baseline to 52 weeks
Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension
Time frame: Baseline to 52 weeks

Results and safety

Results posted to the registry on 14 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIN457 300mg Every 2 Weeks	29	21
AIN457 300 mg Every 4 Weeks	31	20
AIN457 150 mg Every 4 Weeks	31	24
Placebo	34	27

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

Time frame: Baseline to 52 weeks. Median (95% Confidence Interval). Unit: Days

Measure	AIN457 300mg Every 2 Weeks n = 29	AIN457 300 mg Every 4 Weeks n = 31	AIN457 150 mg Every 4 Weeks n = 31	Placebo n = 33
Value	NA (265.0 to NA)	NA (87.0 to NA)	NA (178.0 to NA)	NA (228.0 to NA)

Population analysed: Full analysis set (FAS): all randomized patients who received at least one dose of study drug in the core study and had at least one post-baseline assessment for the primary efficacy parameter or any of its components. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIN457 300mg Every 2 Weeks	4 of 29 (13.8%)	20 of 29 (69%)	Not reported
AIN457 300mg Every 4 Weeks	1 of 31 (3.2%)	19 of 31 (61.3%)	Not reported
AIN457 150mg Every 4 Weeks	1 of 31 (3.2%)	22 of 31 (71%)	Not reported
Placebo Every 2 Weeks	2 of 33 (6.1%)	22 of 33 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

35 sites in 8 countries: see every site and its status.

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 35 sites in 8 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 1 inclusion and 2 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 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Switzerland, Israel, Spain, United Kingdom and 3 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 14 Jan 2016). 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?

The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline (time frame: Baseline to 52 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 NCT01090310.

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 14 Jan 2016.