UveitisPhase 3INSURENCT01095250
Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
A Phase 3 study testing AIN457 in people with Uveitis, run by Novartis Pharmaceuticals at 36 sites in 13 countries.
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
- Uveitis
- What is being tested?
- AIN457
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 36 sitesin 13 countries
- Study dates
- Apr 2010to Oct 2010
- 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
- Male and female subjects ≥18 years of age. Where relevant, parents will also sign the informed consent according to local laws and regulations
- Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye
- Evidence of active intermediate, posterior or panuveitis (grade ≥ 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye
- Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis:
- Prednisone or equivalent ≥10 mg daily at any time within the past 3 months.
- ≥1 periocular injection or ≥1 intravitreal corticosteroid injection (e.g. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening).
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- Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate at any time within the past 3 months (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.
- Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
Who cannot join
- Ocular concomitant conditions/disease
- Patients receiving or that may require prednisone (or equivalent) ≥1.5 mg/kg/day for the treatment of their active uveitis
- 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 infectious uveitis or uveitis of an underlying diagnosis that is uncertain and would reasonably include a disease for which immunosuppression would be contraindicated (e.g. ocular lymphoma)
- Ocular treatments
- Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening
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- Treatment with fluocinolone acetonide implant 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
- Ocular disease that would interfere with ocular evaluations (e.g. corneal scarring, cataract, vitreous hemorrhage) or that in the opinion of the investigator would complicate the evaluation of the safety or efficacy of the study treatment (e.g. uncontrolled glaucoma, toxoplasma scar, macular scarring)
- Current use of or likely need for systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine, ethambutol, etc.)
- Systemic conditions or treatments
- Any previous treatment with AIN457
- 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
36 sites in 13 countries.
36 sites in 13 countries
Japan9 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8655
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Fukushima, Fukushima, 960-1295
Novartis Investigative Site
Kyoto, Kyoto, 602-8566
Novartis Investigative Site
Mitaka, Tokyo, 181-8611
Novartis Investigative Site
Osaka, Osaka, 545-8586
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
Novartis Investigative Site
Shimotsuka-gun, Tochigi, 321-0293
Novartis Investigative Site
Suita, Osaka, 565-0871
United States5 sites
Novartis Investigative Site
Arlington, Texas, 76012
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Cambridge, Massachusetts, 02142
Novartis Investigative Site
Houston, Texas, 77025
Novartis Investigative Site
Slingerlands, New York, 12159
Switzerland5 sites
Novartis Investigative Site
Bern, 3010
Novartis Investigative Site
Bern, 3012
Novartis Investigative Site
Lausanne, CHE, 1004
Novartis Investigative Site
Lucerne, 6000
Novartis Investigative Site
Sankt Gallen, 9007
Israel4 sites
Novartis Investigative Site
Afula, 18101
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Ramat Gan, 52621
Novartis Investigative Site
Tel Aviv, 64239
Canada3 sites
Novartis Investigative Site
London, Ontario, N6A 4G5
Novartis Investigative Site
Montreal, Quebec, H3A 1A1
Novartis Investigative Site
North York, Ontario, M3N 2V6
Germany2 sites
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Göttingen, D-37075
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
About this study
Official title: A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior or Panuveitis Requiring Immunosuppression (INSURE Study)
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.
- Conditions
- Uveitis
- Being tested
- AIN457, Placebo
- Keywords
- Active uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
- Medical subject headings
- Uveitis, Uveitis, Intermediate, Panuveitis, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIN457Drug
AIN457Drug
AIN457Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AIN457 300mg s.c every 2 weeks | Experimental | AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks. Receives: Drug: AIN457 |
| AIN457 300mg s.c. every 4 weeks | Experimental | AIN457 300 mg s.c. at baseline and Week 2, then every 4 weeks. Receives: Drug: AIN457 |
| AIN457 150mg s.c every 4 weeks | Experimental | AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks Receives: Drug: AIN457 |
| Placebo s.c every 2 weeks | Placebo comparator | Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Measured: baseline to 28 weeks
Secondary outcomes (5)
Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Measured: baseline to 28 weeks
Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Measured: baseline to 28 weeks
Change From Baseline in Quality of Life/Patient Reported Outcome Assessments
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Measured: baseline to 28 weeks
Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Measured: baseline to 28 weeks
Change in Immunosuppressive Medication Score From Baseline to Week 28
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
Measured: baseline to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Terminated: Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095250
- Sponsor's protocol ID
- CAIN457C2302
- Other IDs
- 2009-014834-22, 2009
- Acronym
- INSURE
- Status last verified
- Oct 2015
- First submitted
- 25 Mar 2010
- Last updated
- 3 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior or Panuveitis Requiring Immunosuppression (INSURE Study)
- ClinicalTrials.gov ID
- NCT01095250
- Acronym / sponsor ID
- INSURE / CAIN457C2302
- Conditions
- Uveitis
- Keywords
- Active uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated: Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Posted 3 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 s.c every 2 weeks | Experimental | Drug: AIN457AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks. |
| AIN457 300mg s.c. every 4 weeks | Experimental | Drug: AIN457AIN457 300 mg s.c. at baseline and Week 2, then every 4 weeks. |
| AIN457 150mg s.c every 4 weeks | Experimental | Drug: AIN457AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks |
| Placebo s.c every 2 weeks | Placebo comparator | Drug: PlaceboPlacebo s.c at baseline, Week 1 and Week 2, then 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 (9 listed)
- Male and female subjects ≥18 years of age. Where relevant, parents will also sign the informed consent according to local laws and regulations
- Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye
- Evidence of active intermediate, posterior or panuveitis (grade ≥ 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye
- Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis:
- Prednisone or equivalent ≥10 mg daily at any time within the past 3 months.
Key exclusion criteria (16 listed)
- Ocular concomitant conditions/disease
- Patients receiving or that may require prednisone (or equivalent) ≥1.5 mg/kg/day for the treatment of their active uveitis
- 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 infectious uveitis or uveitis of an underlying diagnosis that is uncertain and would reasonably include a disease for which immunosuppression would be contraindicated (e.g. ocular lymphoma)
- Ocular treatments
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 |
|---|---|---|
| AIN457 | Drug | AIN457 300mg s.c every 2 weeks |
| AIN457 | Drug | AIN457 150mg s.c every 4 weeks |
| AIN457 | Drug | AIN457 300mg s.c. every 4 weeks |
| Placebo | Drug | Placebo s.c every 2 weeks |
Primary outcome
Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier.
Time frame: baseline to 28 weeks
No patients of Study CAIN457C2303 achieved the milestone of the primary endpoint in non-infectious uveitis patients with Behçet's disease. Study CAIN457C2302 (active uveitis study) was terminated to avoid continuing patients on a study with a low probability of success.Since patients did not reach the endpoint of analysis there can be no meaningful interpretation of data and data will be not provided.
5 secondary outcomes
Proportion of Responders With no Recurrence of Active Intermediate, Posterior, or Panuveitis in the Study Eye at 28 Weeks
Time frame: baseline to 28 weeks
Mean Change in Best Corrected Visual Acuity From Baseline to 28 Weeks
Time frame: baseline to 28 weeks
Change From Baseline in Quality of Life/Patient Reported Outcome Assessments
Time frame: baseline to 28 weeks
Mean Change in Vitreous Haze Grade and Anterior Chamber Cell Grade From Baseline to 28 Weeks
Time frame: baseline to 28 weeks
Change in Immunosuppressive Medication Score From Baseline to Week 28
Time frame: baseline to 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23290985Dick 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.
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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
36 sites in 13 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 Uveitis, run by Novartis Pharmaceuticals at 36 sites in 13 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 9 inclusion and 16 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 3 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 36 sites in Japan, United States, Switzerland, Israel, Canada and 8 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 3 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?
Mean Change in Vitreous Haze Grade in the Study Eye From Baseline to 28 Weeks or at Time of Rescue, if Earlier. (time frame: baseline to 28 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 NCT01095250, 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 3 Nov 2015.