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1 Clinical Trial Details (PDF Generation Date :- Thu, 01 Nov :59:59 GMT) CTRI Number CTRI/2007/091/ [Registered on: 20/12/2007] - Last Modified On 22/07/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Biological Randomized, Parallel Group, Placebo Controlled Trial A double blind clinical trial to study the multiple dose effect of the study drug on safety, effectiveness and blood levels of the drug in patients with Ulcerative colitis who are non responsive to steroids. A randomized, double blind, placeo controlled evaluation of the safety, efficacy and pharmacokinetics of multiple doses of Basiliximab with concomitant corticosteroids in steroid refractory Ulcerative colitis. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) BSX-001, Amendment 2, 21 Dec 2006 NCT Designation Affiliation Protocol Number ClinicalTrials.gov Details of Principal Investigator Dr Smita Deshmukh Deputy Manager Clinigene International Ltd. Phone Fax Designation Affiliation Clinigene International Ltd., Clinigene House, Tower 1, Semicon Park, Phase II Electronics City, Hosur Road, Clinigene International Ltd., Clinigene House, Tower 1, Semicon Park, Phase II Electronics City, Hosur Road, smita.deshmukh@clinigeneintl.com Details Contact Person (Scientific Query) Dr Anand Eswaraiah Head- CDMB & CDRA Clinigene International Ltd. Phone Fax Designation Affiliation Clinigene International Ltd., Clinigene House, Tower 1, Semicon Park, Phase II Electronics City, Hosur Road, anand.eswaraiah@clinigeneintl.com Details Contact Person (Public Query) Dr Anand Eswaraiah Head- CDMB & CDRA Clinigene International Ltd. Clinigene International Ltd., Clinigene House, Tower 1, Semicon page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Park, Phase II Electronics City, Hosur Road, Source of Monetary or Material Support > Cerimon Pharmaceuticals, Inc. 701 Gateway Boulevard, Suite 100 South San Francisco CA Primary Sponsor Details Cerimon Pharmaceuticals Inc Cerimon Pharmaceuticals, Inc. 701 Gateway Boulevard, Suite 100 South San Francisco CA Type of Sponsor Nil List of Countries Belgium Czech Republic Poland Russian Federation Slovakia Ukraine United Kingdom United States of America of Principal Investigator Dr Shine Sadasivan Dr E Peda Veerraju Pharmaceutical industry-global of Site Site Phone/Fax/ Amrita Institute of Medical Sciences and Research Centre gastroenterology, Amrita Institute of Medical Sciences, Amritha lane,ellamakkara post Kochi Ernakulam KERALA Andhra Medical College Dept. of gastroenterology, Andhra Medical College, Visakhapatnam Visakhapatnam ANDHRA PRADESH Dr Ajay Kumar Apollo Apollo, Gastroenterology, Spectra Clinical Research, Basement,Hostel shines@aims.amrita.ed u epvr515@yahoo.co.uk scrcdelhi@rediffmail.co m page 2 / 7

3 Dr Varghese Thomas Dr Ramakrishna Dr Ajit Sood Complex, Sarita Vihar, New Delhi New Delhi DELHI Calicut Medical College Dept of Gastroenterology Calicut Medical College Kozhikode Kozhikode KERALA Christian Medical college Dayanand Medical College and Dr Prashant Bhandakar Gastroenterology & Endoscopy Center Dr Gopal Krishna Dhali Dr B S Satyaprakash Institute of Postgraduate Medical Education and Research M S Ramaiah Memorial Gastroenterology, Christian Medical College, Vellore Vellore TAMIL NADU Medicine,Dayanand Medical College and Tagore Nagar, Civil Lines, Ludhiana Ludhiana PUNJAB Gastroenterology & Endoscopy center, 128, 1st Floor, Shriman Complex, Near Lokmat square, Wardha Road, Nagpur Nagpur MAHARASHTRA School of digestive and liver diseases, Institute of Postgraduate Medical Education and Research, Rabindra Sadan, Calcutta Kolkata WEST BENGAL Gastroenterology, MS Ramaiah Memorial, New BEL Road, MS Ramaiah Nagar, MSRIT Post, Dr Dinesh Kini Manipal Manipal, Gastroenterology, 98 Rustom Bagh, Airport Road, -17 Dr B Prabhakar Osmania General Dept Of Gastroenterology drvarghesethomas@gm ail.com rama@cmcvellore.ac.in ajitsood10@sify.com gaec@satyam.net.in gkdhali@yahoo.co.in satyaprakash@gmail.co m shwetha.v@acunovalife.com page 3 / 7

4 Details of Ethics Committee Dr Anand Joshi Dr G N Ramesh P D Hinduja National P.V.S. Memorial DrUday Chand Ghoshal Sanjay Gandhi Postgraduate Institute of Medical Sciences Osmania General, Afzalganj, Hyderabad Hyderabad ANDHRA PRADESH P D Hinduja National, Gastroenterology, Veer Savarkar Marg,Mahim, Mumbai Mumbai MAHARASHTRA Gastroenterology P.V.S. Memorial, Kaloor, Cochin , Kerala Ernakulam KERALA Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road Lucknow Lucknow UTTAR PRADESH bprabhakardr@yahoo.c om Joshianand3@rediffmai l.com gnram@satyam.net.in ghoshal@sgpgi.ac.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Central Medical Research ethics Committee, Nagpur Drug Trial Ethical Committee, Dayanand Medical College &, Ludhiana Ethical Committee on Clinical Trials, Indrapratha Apollo s, New Delhi Ethics Committee of Christian Medical College, Vellore Ethics Committee of Manipal & Manipal Heart Foundation, Comittee, Calicut Medical College, Kozhikode Committee, AIMS, Kochi Committee, Andhra Medical College, Approved 12/09/2007 Yes Approved 08/09/2007 No Approved 16/07/2007 No Approved 20/11/2007 No Approved 26/10/2007 No Approved 07/09/2007 No Approved 24/09/2007 No Approved 18/07/2007 No page 4 / 7

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Vishakapatnam Committee, Institute of Post graduate Medical Education & Research Centre, Kolkata Committee, Sanjay Gandhi Post Graduate Institute of Medical Science, Lucknow MSRMC Ehical review Board, Banglaore National Health & Education Society, Clinical Research & Ethics Committee, Mumbai Osmania Medical College Ethics Committee, Hyderabad P.V.S Memorial Ethics Committee, Kaloor Status Approved 28/08/2007 No Approved 17/09/2007 No Approved 29/08/2007 No Approved 14/08/2007 No Approved 11/09/2007 No Approved 10/10/2007 No Date Approved/Obtained 27/07/2007 Health Type Patients Condition Ulcerative Colitis Type Details Intervention 40 mg basiliximab Study Drug: basiliximab given as short intravenous infusion Dosing Schedule: at Day 1, week 2 and week 4 for a total of 3 doses Intervention 20 mg basiliximab Study Drug: basiliximab given as short intravenous infusion Dosing Schedule: at Day 1, week 2 and week 4 for a total of 3 doses Comparator Agent Placebo Total of 3 doses at 2 week intervals Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Male or female subjects, age greater or equal to 18 years and & less than or equal to 75 years 2. Weight of 40 kg or greater 3. Signed a current IRB/IEC-approved informed consent form 4. Diagnosis of ulcerative colitis confirmed through screening endoscopy. A rectal biopsy will be obtained and reviewed by a local pathologist. Histopathology must be compatible with the diagnosis. 5. Extent of disease must involve at least the left colon (i.e., greater than 15 cm beyond the anal verge as the endoscope is withdrawn) 6. Moderate to severe disease, defined as a total Mayo score of 6 page 5 / 7

6 points or greater, including an endoscopic subscore of 2 points or greater. Systemic features of tachycardia, fever, and/or significant anemia should not be present 7. Steroid-refractory disease, defined as moderate to severe disease, without systemic features, despite treatment with prednisone 40? 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry 8. Concomitant azathioprine or 6-mercaptopurine treatment is permitted during the study if initiated at least 12 weeks before study entry, and if the dose has not been changed or stopped for at least 8 weeks before study entry. 9. Concomitant oral aminosalicylate treatment is permitted during the study if initiated at least 4 weeks before study entry, and if the dose has not been changed or stopped during this time. 10. Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug. 11. Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years. Exclusion Criteria Details Exclusion Criteria 1. Prior treatment with basiliximab or daclizumab at any time 2. Prior treatment with cyclosporine, tacrolimus, methotrexate, or any anti-tnf agent within 3 months before study entry 3. Prior treatment with parenteral corticosteroids within 14 days before study entry 4. Initiation of azathioprine or 6-mercaptopurine treatment less than 12 weeks before study entry, or discontinuation or change of dose less than 8 weeks before study entry 5. Initiation of oral aminosalicylate treatment, or change of dose, or discontinuation less than 4 weeks before study entry 6. Rectally administered medications containing corticosteroids or aminosalicylates within 2 weeks before screening endoscopy 7. If currently taking a nonsteroidal anti-inflammatory agent (NSAID), the inability to discontinue NSAID use during study participation 8. Intolerance or inability to continue oral corticosteroids during the trial 9. Stool studies that show presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin 10. Colitis that is indeterminate, suggestive of Crohn?s disease, or isolated to the rectum, based on endoscopic and/or biopsy findings 11. Presence of toxic megacolon 12. Severely ill patients as evidenced by greater than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the screening window, concurrent with any of the following systemic features:? Heart rate >90 beats/min at rest? Temperature >37.8 degrees C? Hemoglobin <10.5 g/dl 13. Laboratory values as follows:? Hemoglobin <8.5 g/dl? WBC <3.0 x 109 /L? Neutrophils <1.5 x 109 /L? Lymphocytes <0.5 x 109 /L? Platelets <100 x 109 /L? AST (SGOT) >3 times upper limit of normal? ALT (SGPT) >3 times upper limit of normal 14. Pregnant or breast-feeding female patients 15. Chest radiograph abnormalities consistent with an infectious process 16. Known HIV, or viral Hepatitis B or C infection 17. History of or exposure to tuberculosis within 6 months before study entry 18. History of central nervous system demyelinating disorder 19. History of colonic dysplasia 20. History of malignancy during the previous 5 years or current malignancy, with exception of adequately treated non-melanoma skin cancer or in situ carcinoma of the cervix 21. History of varicella, herpes zoster, or severe viral infection within 6 weeks before study entry, exposure to varicella within 21 days before study entry, or vaccination with live virus within 4 weeks before study page 6 / 7

7 Powered by TCPDF ( PDF of Trial Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Participant, Investigator and Outcome Assessor Blinded entry 22. Any ECG abnormalities not approved by the Medical Monitor 23. Treatment with an investigational drug or device within 30 days before study entry 24. Treatment with an investigational biologic within 6 months before study entry Primary Outcome Outcome Timepoints Clinical Remission 8th Week Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Clinical remission Clinical response Mucosal healing Total Sample Size=181 Sample Size from =45 01/04/ /09/2007 Years=1 Months=0 Days=0 Completed Completed Nil 4th Week 4th and 8th Week 4th and 8th week This is a randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis.This study This study is presently planned as a global study that will include up to 60 investigational sites in as many as eight countries will randomize up to 135 subjects worldwide out of which 40 patients are to be recruited from. A subject will be considered to have entered the study once randomized. Primary objectives of the study includes assessment of the efficacy, relative to placebo, of basiliximab 40 mg, given with concomitant corticosteroids, in subjects with steroid-refractory, moderate to severe ulcerative colitis and to evaluate the overall safety of this multiple-dose regimen. Secondary Objectives include To assess the efficacy of basiliximab 20 mg, given with concomitant corticosteroids, assess the safety of basiliximab 20 mg, in this multiple-dose regimen, assess the pharmacokinetics of both basiliximab regimens, assess the immunogenicity of multiple doses of basiliximab page 7 / 7