UveitisPhase 3INSURENCT01103024
Extension Study to Assess 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 at 11 sites in 5 countries.
Trial 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. 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
- 0 participants
- Where
- 11 sitesin 5 countries
- Study dates
- Dec 2010to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 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
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 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
Show all 11Show fewer
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
Japan6 sites
Novartis Investigative Site
Bunkyō City
Novartis Investigative Site
Fukuoka
Novartis Investigative Site
Fukushima
Novartis Investigational Site
Kyoto, 602-0841
Novartis Investigative Site
Sapporo
Novartis Investigative Site
Tochigi
Canada2 sites
Novartis Investigative Site
London, Ontario
Novartis Investigative Site
North York, Ontario
About this study
Official title: A 34-week Extension to 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)
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.
- 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.
AIN457Biological
AIN457Biological
AIN457Biological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| AIN457 300mg s.c every 2 weeks | Experimental | Not described Receives: Biological: AIN457 |
| AIN457 300mg s.c every 4 weeks | Experimental | Not described Receives: Biological: AIN457 |
| AIN457 150mg s.c every 4 weeks | Experimental | Not described Receives: Biological: AIN457 |
| Placebo s.c every 2 weeks | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence
Measured: baseline to 52 weeks
Secondary outcomes (5)
Change in immunosuppressive medication score from core study baseline
Measured: 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
Measured: baseline to 52 weeks
Mean change in best corrected visual acuity from baseline
Measured: baseline to 52 weeks
Change from baseline in Quality of Life/Patient reported outcome assessments
Measured: baseline to 52 weeks
Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks
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.
- First posted13 Apr 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Core study in non-infectious active uveitis was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103024
- Sponsor's protocol ID
- CAIN457C2302E1
- Other IDs
- 2009-015509-38, 2009
- Acronym
- INSURE
- Status last verified
- Sep 2020
- First submitted
- 9 Apr 2010
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 34-week Extension to 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
- NCT01103024
- Acronym / sponsor ID
- INSURE / CAIN457C2302E1
- Conditions
- Uveitis
- Keywords
- Active uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Core study in non-infectious active uveitis was terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 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 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
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 | Biological | AIN457 300mg s.c every 2 weeks |
| AIN457 | Biological | AIN457 300mg s.c every 4 weeks |
| AIN457 | Biological | AIN457 150mg s.c every 4 weeks |
| Placebo | Biological | Placebo s.c every 2 weeks |
Primary outcome
Rate of recurrence
Time frame: baseline to 52 weeks
5 secondary outcomes
Change in immunosuppressive medication score from core study baseline
Time frame: 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
Time frame: baseline to 52 weeks
Mean change in best corrected visual acuity from baseline
Time frame: baseline to 52 weeks
Change from baseline in Quality of Life/Patient reported outcome assessments
Time frame: baseline to 52 weeks
Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks
Time frame: baseline to 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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
11 sites in 5 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 at 11 sites in 5 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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan, Canada, United States, Israel, Switzerland. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of recurrence (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?
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 29 Sep 2020.