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CTRI Number  CTRI/2010/091/000479 [Registered on: 07/09/2010]
Last Modified On: 02/10/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis (INSURE) 
Scientific Title of Study   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) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CAIN457C2302  Protocol Number 
NCT01095250  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Muruganananthan K 
Designation  Head Clinical Development 
Affiliation   
Address  Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India 
Phone  02224958545  
Fax  02224954112  
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Murugananthan K 
Designation  Head Clinical Development 
Affiliation   
Address  Novartis Healthcare Private Limited, Medical Department,
Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli,
Mumbai
MAHARASHTRA
400 018
India 
Phone  02224958545  
Fax  02224954112  
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Basel, Switzerland. 
 
Primary Sponsor
Modification(s)  
Name  Novartis Healthcare Pvt Ltd 
Address  Medical Dept., Sandoz House, Shiv Sagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400018 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Rajvardhan Azad  AIIMS  Room No: 486, 4th floor office block, Dr. R P Centre for Ophthalmic sciences,Ansari Nagar,-110029
New Delhi
DELHI 		 011 26593187

rajvardhan.azad@gmail.com 
Dr. B. Manohar Babu  Aravind Eye Hospital  Avinashi Road,-641 014
Coimbatore
TAMIL NADU 		 422 4360400

dr.mb@cbe.aravind.org 
Dr. S. R Rathinam  Aravind Eye Hospital  Uveitis Services, 1, Anna Nagar,,-625 020
Madurai
TAMIL NADU 		 0452 4356100

rathinam@aravind.org 
Dr.Padmamalini Mahendradas  Narayana Nethralaya (NN1)  121/C, 1st 'R' Block, ,Chord Road, Rajajinagar- 560 010
Bangalore
KARNATAKA 		 080 - 66121319

padmamalini@narayananethralaya.com 
Dr. Amod Gupta  Post Graduate Institute of Medical Education & Research  Room No. 116, Ground floor,-160 012
Chandigarh
CHANDIGARH 		 0172 2756111

eyepgi@sify.com 
Dr. Himadri Datta  Regional Institute of Ophthalmology  Medical College,88 College Street, -700 073

 		 033 ? 4007 1886

himadri.datta@gmail.com 
Dr. Manish Nagpal  Retina Foundation and Eye Research Center Asopalav Eye Hospital  Near Under bridge, Old Raj Bhavan road,,Next to hotel Naeeka, Shahibaug-380 004
Ahmadabad
GUJARAT 		 079 22865537

drmanishnagpal@yahoo.com 
Dr. Jyotirmay Biswas  Vision research Foundation  Shankara Nethralaya,18 College Road-600 006
Chennai
TAMIL NADU 		 +91 9841428151

drjb@snmail.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Ethical Committee, Regional institute of Ophthalmology Medical college & Hospital  Submittted/Under Review 
Ethics Committee / Institutional Review Board, Madurai  Submittted/Under Review 
Ethics Committee / Institutional Review Board, Madurai  Submittted/Under Review 
ETHICS SUB COMMITTEE, Chennai  Approved 
Institute Ethics Committee, Chandigardh  Submittted/Under Review 
Institution Ethics Committee, All India Institute of Medical Sciences New Delhi   Approved 
Narayana Nethralaya Ethics Committee, Bangalore  Submittted/Under Review 
The Institutional Review Board, ARAVIND EYE CARE SYSTEM  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Uveitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AIN457  AIN457 150mg s.c every 4 weeks 
Intervention  AIN457   AIN457 300mg s.c every 2 weeks 
Intervention  AIN457   AIN457 300mg s.c. every 4 weeks 
Comparator Agent  Placebo   Placebo s.c every 2 weeks  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Day(s)
Age To  0.00 Day(s)
Gender  Both 
Details  Male and female subjects greater than or equal to 18 years of age. Where relevant, parents will also sign the
informed consent according to local laws and regulations.
2. Patients with diagnosis of chronic non infectious intermediate uveitis, posterior uveitis or
panuveitis in at least one eye
3. Evidence of active intermediate, posterior or panuveitis (grade greater than or equal to 2+ vitreous haze with or
without the presence of anterior chamber cells) at screening and baseline in at least one eye
4. Requirement for any of the following immunosuppressive therapies for the treatment or
prevention of uveitis
• Prednisone or equivalent greater than or equal to 10 mg daily at any time within the past 3 months
• Greater than or equal to 1 periocular injection or greater than or equal to 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 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
5. 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 
 
ExclusionCriteria 
Details  Ocular concomitant conditions or disease
1. Patients receiving or that may require prednisone (or equivalent) greater than or equal to 1.5 mg/kg/day for the
treatment of their active uveitis.
2.Patients with a primary diagnosis of Behçets 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 (e.g. punctuate inner choroidopathy (PIC), acute zonal occult outer
retinopathy (AZOOR)
3. 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
4. Treatment with intravitreal antiVEGF agents administered to the study eye within 3 months
prior to screening.
5. 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.
6. 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.
7. Planned elective ocular surgery during the study.
8. 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).
9. 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
10. Any previous treatment with AIN457
11. 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.
12. Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within
the past 5 years prior to screening.
13. 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.
14. Active systemic infections during the last two weeks prior to screening (exception. common
cold)
15. Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions
which in the opinion of the investigator immunocompromises the patient and/or places the
patient at an unacceptable risk for participation in an immunomodulatory therapy.
16. Systemic or extraocular disease that would contraindicate long-term immunosuppression,
especially infectious diseases such as
• any active, chronic or localized infection
• a history of an infectious disease that can spontaneously reemerge or that is impossible
to completely cure, such as histoplasmosis, toxoplasmosis, malaria, viral hepatitis, and
HIV AIDS
• history of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis
infection as defined by either a positive PPD skin test or a positive QuantiFERON TBGold
test. Patients with evidence of latent tuberculosis may enter the trial after evaluation
15. Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions
which in the opinion of the investigator immunocompromises the patient and/or places the
patient at an unacceptable risk for participation in an immunomodulatory therapy.
16. Systemic or extraocular disease that would contraindicate long term immunosuppression,
especially infectious diseases such as
• any active, chronic or localized infection
• a history of an infectious disease that can spontaneously re-emerge or that is impossible
to completely cure, such as histoplasmosis, toxoplasmosis, malaria, viral hepatitis, and
HIV AIDS
• history of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis
infection as defined by either a positive PPD skin test or a positive QuantiFERON TBGold
test. Patients with evidence of latent tuberculosis may enter the trial after evaluation.
by a appropriate specialist and after sufficient treatment has been initiated according to
local regulations or standard of care
17. History of lymphoproliferative disease or any known malignancy or history of malignancy
within the past 5 years of any organ system, treated or untreated, whether or not there is
evidence of local recurrence or metastases (except for non-melanoma skin cancer that has
been treated with no evidence or recurrence in the past 3 months, carcinoma in situ of the
cervix or colon polyps with non invasive malignancy that have been removed).
18. History of ongoing drug or alcohol abuse within the 6 months prior to screening or clinical
evidence of such abuse or clinical suspicion of such abuse.
19. 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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in vitreous haze grade in the study eye from baseline to 28 weeks or at time of rescue, if earlier.  baseline to 28 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
? Mean change in best corrected visual acuity from baseline to 28 weeks   baseline to 28 weeks  
? Proportion of responders with no recurrence of active intermediate, posterior, or panuveitis in the study eye at 28 weeks   baseline to 28 weeks  
? Change from baseline in Quality of Life/Patient reported outcome assessments   baseline to 28 weeks  
? Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 28 weeks   baseline to 28 weeks 
? change in immunosuppressive medication score from baseline to Week 28   baseline to 28 weeks  
 
Target Sample Size
Modification(s)  		 Total Sample Size="208"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 10/09/2010 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/04/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Other (Terminated) 
Recruitment Status of Trial (India)   
Publication Details
Modification(s)  		 No Publication provided. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Target number of patients from India is 34. FPFV planned for the study is 10-Sep-2010. No patients screened from India 
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