CTRI/2025/02/080437 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On:
20/09/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Study to Compare the Efficacy, Safety, Immunogenicity and
Pharmacokinetics of Biosimilar Vedolizumab Injection in Patients with Moderate to Severe Active
Ulcerative Colitis
Scientific Title of Study
A Phase 3, Randomized, Double-Blind, Multicenter, Active-
Controlled, Two-Arm, Parallel Group Study to Compare the Efficacy, Safety,
Immunogenicity and Pharmacokinetics of the Proposed Biosimilar of
Vedolizumab (INTP53) Intravenous Injection and Vedolizumab Reference for
Induction and Maintenance Therapy in Patients with Moderate to Severe Active
Ulcerative Colitis
Department of Clinical research, Room No. NA, Advance Gastro & Liver Care Block-3,S9 Landmark,Opp.TVS Showroom,Near Hanuman Tekari, Abu Highway,Palanpur-385001.
Banas Kantha GUJARAT
9879344302
drekantsg@gmail.com
Dr Rupa Banerjee
AIG Hospital
Department of Clinical research, Room No. NA, Survey No. 136, 4/5, Plot no. 2/3, Midspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana- 500032
Hyderabad TELANGANA
9849287530
rupabanerjee.aig@gmail.com
Dr Abhilash Mansukhlal Surela
Anand Multispeciality Hospital & Research Center
Department of Clinical research, Room No. NA, 4th Floor, Sarthak Mall, Mahatma Mandir Road, Sargasan, Gandhinagar- 382421, Gujarat, India.
Gandhinagar GUJARAT
9909718158
surelaabhilash@gmail.com
Dr Prashant Katiyar
Atharva Multispeciality Hospital & Research Centre
Department of Clinical research, Room No. NA, H-4/Comm-2, Construction Div-21, UP Avas Vikas Parishad, Sector- E, Lucknow- 226003, U.P, India.
Lucknow UTTAR PRADESH
9565993769
hospital.atharva@gmail.com
Dr Srishail Hanagandi
Belagavi Institute of Medical Sciences
Department of Clinical research, Room No. NA, 3rd Floor, BIMS building, Dr. B R Ambedkar Road, Belagavi- 590001, India Belgaum KARNATAKA
9892713562
bimsclinicalresearch@gmail.com
Dr Kaivan Shah
DHS Multispeciality Hospital
Department of Clinical research, Room No. NA, Vastrapur Lake- Himalaya Mall Link Road, Sunrise Park, Vastrapur, Ahmedabad- 380054, Gujarat, India
Ahmadabad GUJARAT
9833622433
drkaivanshah26@gmail.com
Dr Vinay Kumar
G.S.V.M. Medical College
Department of Clinical research, Room No. NA, Swaroop Nagar - 208002, India Kanpur Nagar UTTAR PRADESH
8004877113
dr.vinaysachan@gmail.com
Dr P Shravan Kumar
Gandhi Hospital
Department of Clinical research, Room No. NA, Inpatient block, 5th Floor, Dep. of Gastroenterology, Gandhi Hospital, Musheerabad, Secunderabad (Hyderabad) - 500003, Telangana, India Hyderabad TELANGANA
9848011080
shravangastro@gmail.com
Dr Anumula Kavitha
Government General Hospital
Department of Clinical research, Room No. NA, Room no. 220, Second Floor, GMCANA Building, Department of Gastroenterology - 522001, India Guntur ANDHRA PRADESH
9399977555
jananigastro@gmail.com
Dr Bhabadev Goswami
Institute of Digestive & Liver Disease Dispur Hospital Pvt Ltd.
Department of Clinical research, Room No. NA, Ganeshguri, Guwahati- 781006 Assam, India
Golaghat ASSAM
9864094739
bhabadev@rediffmail.com
Dr Manoj Kumar
Jawahar Lal Nehru Medical College
Department of Clinical research, Room No. NA, Kala Bagh -305001, India Ajmer RAJASTHAN
9468964902
drmanoj.clinical@gmail.com
Dr Harshad Soni
Kaizen Hospital
Department of Clinical research, Room No. NA, 132, Ft. Ring Road, Near Helmet Circle, Memnagar, Ahmedabad- 380052, Gujarat India
Ahmadabad GUJARAT
9898471745
soniharshad77@gmail.com
Dr Ajay Kumar Patwa
King Georges Medical University
Department of Medicine, Room No. NA, Shahmeena Road. Chowk, Lucknow226003, Uttar Pradesh, India Lucknow UTTAR PRADESH
9455519306
drajaymd12345@gmail.com
Dr Santosh Hajare
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
Department of Clinical research, Room No. NA, Nehru Nagar, Belagavi 590010, India Belgaum KARNATAKA
9591358733
drsantoshhajare@gmail.com
Dr Shah Chirag Narendrakumar
Mission Gastro Hospital
Department of Clinical research, Room No. NA, 603 Golden Icon, Opp. Medilink Hospital, between Shivranjani Shyamal Cross Road 132 Fett Ring Rd. Satellite - 380015, India Ahmadabad GUJARAT
7567159591
drchirag29606@gmail.com
Dr Patel Pinakin Sureshbhai
Narayana Multispeciality Hospital
Department of Clinical research, Room No. NA, Unit of Narayana Hrudayalaya Ltd. Opp. Police Station, Rakhiyal Cross Road, Ahmedabad- 380023, Gujarat, India.
Ahmadabad GUJARAT
7045546896
drpinakinpatel86@gmail.com
Dr Shah Ishan Anil Kumar
Navneet Memorial Hospital
Department of Clinical research, Room No. NA, Opp. Sardar Patel Seva Samaj Hall, In Lane, Opp. Navrangpura Telephone Exchange, Off C.G Road, Navrangpura, Ahmedabad- 380006 Gujarat.
Ahmadabad GUJARAT
9599555795
docishanshah@gmail.com
Dr Pinaki Roy
NRS Medical College And Hospital
Department of Clinical research, Room No. NA, 138, A.J.C Bose Road, Sealdeah - 700014, India Kolkata WEST BENGAL
9474891727
drpinaki1979@gmail.com
Dr MD Aejaz Habeeb
Origin Hospital
Department of Clinical research, Room No. NA, A Unit of C.L.R.D.2-5-36/ CLRD 11, Chitalmet X Road, Near Pillar No. 177, PVNR Expressway, Attapur - 500048, India Hyderabad TELANGANA
9848034860
aejazhabeeb@hotmail.com
Dr Vinay B N
PMSSY Hospital & Victoria Hospital
Department of Clinical research, Room No. NA, Bangalore Medical College & Research Institute, Bangalore- 560002, Karnataka
Bangalore KARNATAKA
9972121844
vinaybndoc@gmail.com
Dr Anupam Kumar Singh
Postgraduate Institute of Medical Education and Research
Department of Clinical research, Room No. NA, Sector-12 Chandigarh- 160012, India
Chandigarh CHANDIGARH
8284822540
anupam.pgi@gmail.com
Dr Hemant kumar Gupta
Samvedna Hospital
Department of Clinical research, Room No. B 27/88G, New colony, Ravindrapuri, -221005, India Varanasi UTTAR PRADESH
9415336365
hemantkrg26@gmail.com
Dr Kabrawala Mayank Vasantlal
SIDS Hospital and Research Centre
Department of Clinical
research, Room No.
NA, A Unit of SIDS Healthcare Private Limited. Off Ring Road, Near Shell Petrol Pump, Ring Road- Sosyo Circle lane, 395002, India Surat GUJARAT
9825130363
mayankkabrawala@gmail.com
Dr Sudhir Maharshi
SMS Super Speciali ty Hospital
Department of Clinical research, Room No. NA, Vivekanand Marg, C-Schema -302004, India Jaipur RAJASTHAN
8130369247
drsudhirmaharshi05@gmail.com
Dr Rishikesh VasantKumar Kalaria
Sterling Hospital
Department of Clinical research, Room No. NA, Unit of Sterling Add-Life India Pvt Ltd., Plot no. 251, 150 Feet Ring Road, Nr. Raiya Circle, Rajkot- 360007 Gujarat, India.
Rajkot GUJARAT
8879518870
kalaria.rishikesh@gmail.com
Dr Shubhra Mishra
The Gastro Liver Hospital
Department of Clinical research, Room No. NA, The Gastro Liver Hospital D 1,2,3 VIP Road, Swaroop Nagar, Kanpur, Uttar Pradesh-208002
Kanpur Nagar UTTAR PRADESH
7838655131
shubhra.mishra91@gmail.com
Dr Shubham Jain
TNMC BYL NAIR HOSPITAL
Department of Clinical research, Room No. NA, Anand Rao Nair Road, Mumbai Central East, 400 008, India. Mumbai MAHARASHTRA
7710915754
dr.shubhamjazz@gmail.com
Dr Takalkar Unmesh Vidyadha
United CIIGMA Institute of Medical Sciences Pvt. Ltd
Department of Clinical research, Room No. NA, Plot No 6, 7, Survey No 10. Shahnoorwadi Dargah Road, 431005, India Aurangabad MAHARASHTRA
Anand Ethics Committee, Dr. Abhilash Mansukhlal Surela
Approved
Apollo Specialty Hospitals Kanpur Ethics Committee, Dr. Shubhra Mishra
Approved
ECKMHGCH United CllGMA Institute of Medical Sciences Pvt.Ltd, Dr. Takalkar Unmesh Vidyadha
Approved
Ethics Committee Dispur Hospital Pvt Ltd, Dr. Bhabadev Goswami
Submittted/Under Review
ETHICS COMMITTEE GMC and GGH, Dr. Anumula Kavitha
Approved
ETHICS COMMITTEE GSVM MEDICAL COLLEGE, Dr. Vinay Kumar
Approved
Ethics Committee of BMCRI, Dr. Vinay B N
Approved
Ethics Committee of Navneet Memorial Hospital, Dr. Shah Ishan Anil Kumar
Approved
Ethics Committee S.M.S. Medical College and Attached Hospitals, Dr. Sudhir Maharshi
Approved
Ethics Committee, N.R.S. Medical College, Dr. Pinaki Roy
Approved
Institutional Ethics Committee Asian Institute of Gastroenterology, Dr. Rupa Banerjee
Approved
Institutional Ethics Committee BIMS Belagavi Institute Of Medical Sciences, Dr. Srishail Hanagandi
Approved
Institutional Ethics Committee King Georges Medical University, Dr. Ajay Kumar
Submittted/Under Review
Institutional Ethics Committee Origin Hospital, Dr. MD. Aejaz Habeeb
Approved
Institutional Ethics Committee PGIMER, Dr. Anupam Kumar Singh
Approved
Institutional Ethics Committee TNMC NAIR HOSPITAL, Dr. Shubham Jain
Approved
Institutional Ethics Committee, Atharva Multispeciality Hospital and Research Centre, Dr. Prashant Katiyar
Approved
Institutional Ethics Committee, Dr. P. Shravan Kuma
Submittted/Under Review
Institutional Ethics Committee, Jawahar Lal Nehru Medical College, Dr. Manoj Kumar
Approved
Institutional Ethics Committee, KLE University, Dr. Santosh Hajare
Approved
Kaizen Ethics Committee, Kaizen Hospital, Dr. Harshad Soni
Submittted/Under Review
Palanpur Ethics Committee Cancer Care Hospital, Dr.Gupta Ekant Surendrabhai
Approved
Samvedna Hospital Ethics Committee, Dr. Hemant kumar Gupta
Approved
Sangini Hospital Ethics Committee, Dr. Kaivan Shah
Approved
Sangini Hospital Ethics Committee, Dr. Patel Pinakin Sureshbhai
Approved
Shrey Hospital Institutional Ethics Committee, Dr. Shah Chirag Narendrakumar
Approved
Sterling Institutional Ethics Committee, Dr. Rishikesh VasantKumar Kalaria
Approved
Surat Institute of digestive sciences EC, Dr. Kabrawala Mayank Vasantlal
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Vedolizumab (R)
Dosage Level: 300 mg at zero, two and six weeks and then every eight weeks after that till Week 22, Route of Administration: Intravenous infusion
Intervention
Vedolizumab (T)
Dosage Level: 300 mg at zero, two and six weeks and then every eight weeks after that till Week 22, Route of Administration: Intravenous infusion
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1 Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in section 10.1.3 and in this protocol and is willing to participate in the study.
2 Male or female participants with 18 completed years of age or older at the time of signing the informed consent.
3 Participants must have a documented diagnosis of UC at least three months duration before screening, confirmed by:Medical records with a report of an endoscopy, which shows features consistent with UC, as determined by the procedure performing physician, AND Medical record documentation of a histopathology report showing features consistent with UC, as determined by the local pathologist. Note: If a histopathology report is unavailable, histologic samples can be obtained at the screening endoscopy and sent to a local laboratory to confirm UC diagnosis before randomization. The screening endoscopy must show features consistent with UC, and medical records must still document a clinical diagnosis of UC at least three months duration before screening.
4 Participant has moderately to severely active UC as defined by a Complete Mayo score of 6 to 12 (both inclusive) with an endoscopic subscore (ES) greater than or equal to 2 (with endoscopy performed within ten days before the first dose of investigational intervention), a rectal bleeding subscore greater than or equal to 1, and a stool frequency subscore greater than or equal to 1 during the screening period (before randomization on Day 1).
5 Participants have evidence of UC extending proximal to the rectosigmoid junction (greater than or equal to 15 cm of the involved colon from the anal margin) as determined by screening endoscopy. Participants with rectal sparing on screening endoscopy must have documentation of rectal involvement on a prior endoscopy and histopathology report to confirm UC diagnosis.
6 Have documentation of:A surveillance colonoscopy for dysplasia (performed according to local standards) within 12 months before the first administration of investigational intervention for: a participants with pancolitis of greater than 8 years duration or a participants with left-sided colitis of greater than 12 years of duration or a participants with primary sclerosing cholangitis. OR Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age greater than 50 years, or other known risk factors must either have had a full colonoscopy to assess for the presence of adenomatous polyps within five years before the first administration of investigational intervention. Participants who do not have a colonoscopy report available in source documentation must have a colonoscopy at screening.
7 Participants must have an inadequate response to, loss of response to, or intolerance to a treatment course of one or more of the following standard of care medications described below as A OR B. Documentation of dose, dates, frequency, route of administration, and duration of the prior failed treatment, as well as documents that the participant had persistent disease activity UC treatment, is required.
Signs and symptoms of persistently active disease for this inclusion criteria are defined as the lack of improvement or worsening of at least 1 of the following: stool frequency, rectal bleeding, daily abdominal pain, worsening in urgency, and endoscopic appearance of the colonic mucosa. These signs and symptoms of UC are offered only as a benchmark of the minimally acceptable criteria. The ultimate decision to reduce the dose or discontinue UC drugs due to intolerance remains at the discretion of the investigator.
8 A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies
9 Participants with adequate haematology, liver and renal function at screening visit: a. Total WBC count greater than or equal to 3000 per cu.mm
b. Absolute neutrophil count greater than or equal to 1000 per cu.mm c. Absolute lymphocyte count greater than or equal to 500 per cu.mm d. Hb greater than or equal to 8 g per dL e. Platelet count greater than or equal to 100,000 per cu.mm
f. AST AND ALT less than or equal to 3 into ULN g. Total bilirubin less than or equal to 1.5 into ULN (isolated total bilirubin greater than 1.5 into ULN is allowed for those participants with known Gilberts syndrome; Gilberts syndrome is suggested by direct bilirubin less than 30 percent). h. Creatinine less than or equal to 2 into ULN
10 Willing and able to adhere to the lifestyle restrictions specified in this protocol.
11 Each potential participant must satisfy all of the following criteria to be enrolled in the study: Must be able to read, understand, and complete the patient diary. Must intend to comply with the completion of the patient diary.
ExclusionCriteria
Details
1 Documented medical history of uncontrolled, clinically significant intercurrent cardiac, vascular, pulmonary, gastrointestinal other than ulcerative colitis, endocrine, neurologic, haematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
2 Known history of serious or severe allergies, hypersensitivity, or intolerance to any chimeric, human, or humanized antibodies, fusion proteins, or murine proteins OR to
investigational interventions, components/ excipients thereof (L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, Sucrose, Polysorbate 80), OR any other
drug allergy that, in the opinion of the investigator, contraindicates participation in the study.
3 Contraindications to the use of any of the investigational interventions or components/excipients per DCGI approved PI of Kynteles[3] or SmPC of Entyvio [1]
4 Participant has one or more of the following gastrointestinal conditions with
documented evidence at the screening visit a. Have a current diagnosis of Crohn’s disease or inflammatory bowel disease unclassified (IBD-U) (formerly known as indeterminate colitis), ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis or any other abnormality which may affect the objective assessment as per PI’s judgment
b. Presence of symptomatic colonic or small bowel obstruction, confirmed by objective radiographic or endoscopic evidence of stricture with resulting obstruction (dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy). c. Previous bowel resection or intestinal or intra-abdominal surgery. d. Presence of a stoma. e. Presence or history of a fistula. f. Current or recent (within 12 weeks before the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation. g. Any history or current evidence of cancer of the gastrointestinal tract.
5 Has prior or current evidence of definite low-grade or high-grade colonic dysplasia including dysplasia identified during the screening endoscopy that has not been completely removed. Once completely removed, the participant is eligible for the study.
6 Has severe extensive colitis as evidenced by:
7 Exclusion Criteria Related to Prior or Concomitant Therapy
8 Participants with ongoing/inadequately treated serious, opportunistic or chronic/recurring extraintestinal infections at screening visit including but not limited
to the following.
9 Any current signs or symptoms of active extraintestinal infection within two weeks before the first dose of study intervention, except for the following:
10 Have evidence of active infectious herpes zoster infection less than or equal to 8 weeks before screening. Herpes zoster infections remain active until all vesicles are crusted over.
11 Had evidence of treatment for Clostridium difficile within 4 weeks of the first dose of investigational intervention or test positive for C. difficile. If a participant is positive
for C. difficile at screening, the participant may be treated and rescreened less than or equal to 4 weeks after completing treatment.
12 Clinically significant abnormalities on screening neurologic examination (PML Objective Checklist and PML Subjective Checklist). Participant may be rescreened once PML is ruled out conclusively by neurologist.
13 Presence of current acute or chronic hepatitis B infection or test positive for hepatitis B virus (HBV) at screening. Refer to Appendix 7 for eligibility based on the HBV
serologic markers.
14 Presence of current hepatitis C infection or test positive for hepatitis C virus (HCV) at screening. Refer to Appendix 7 for eligibility based on the HCV serologic markers.
15 Has known human immunodeficiency virus (HIV) seropositive status or positive HIV antibody test at screening.
16 The participant has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency).
17 Have evidence of active or latent infection with Mycobacterium tuberculosis (TB) as defined by either of the following.
18 Evidence of or treatment for clinically significant cytomegalovirus (CMV) colitis
(based on the investigator’s judgment) within 60 days before the first dose of investigational intervention. Laboratory confirmation of CMV from colon biopsy is required during screening evaluation only if clinical suspicion is high. Participants with a confirmed diagnosis of cytomegalovirus-associated colitis should have adequate treatment and resolution of symptoms at least three months before the first dose of investigational intervention.
19 Participants who have received any live vaccinations within four weeks before the first dose of the investigational intervention or intend to receive such during the study.
20 Have a solid organ transplant (except for a corneal transplant performed greater than 12 weeks before screening) or hematopoietic stem cell transplantation.
21 History of drug or alcohol abuse according to medical history assessment by the investigator within one year before Screening.
22 History of malignancy within the past five years except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least three years since initiating that therapy.
Note: The time requirement does not apply to participants with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ
cervical cancer, or other in situ cancers who underwent successful definitive resection with no evidence of metastatic disease which is considered cured with minimal risk of
recurrence.
23 Received an investigational intervention or used an invasive investigational medical device within 30 days or five half-lives before the first dose of investigational intervention, whichever is longer, before signing the consent or is currently enrolled in an investigational study.
24 Participants with uncontrolled hypertension (systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg) despite optimal antihypertensive treatment at screening. If blood pressure is out of range, up to 2 repeated assessments are permitted no more than 60 minutes apart. Note: Participants may be retested or rescreened after initiation or adjustments of antihypertensive medications to establish control.
25 Participants with uncontrolled diabetes mellitus (defined as HbA1c greater than 8 percent) at screening. Note: Participants may be retested or rescreened after initiation or adjustments of antidiabetic medications to establish control.
26 The participant with a systolic blood pressure of less than 90 mmHg at screening. If blood pressure is out of range, up to 2 repeated assessments are permitted no more than 60 minutes apart. Note: Participants may be retested or rescreened after correction of blood pressure.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
An Open list of random numbers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To establish non-inferiority for the clinical response rates associated with vedolizumab-test compared to vedolizumab-reference at Week 6 in participants with moderately to
severely active ulcerative colitis
Week 0, Week 2, Week 6, Week 14, Week 22 and Week 26 / EOS visit
Secondary Outcome
Outcome
TimePoints
To further evaluate the efficacy of
vedolizumab-test compared to
vedolizumab-reference in participants
with moderately to severely active
ulcerative colitis
Week 0, Week 2, Week 6, Week 14, Week 22 and Week 26 / EOS visit
Target Sample Size
Total Sample Size="214" Sample Size from India="214" 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)
24/02/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a study to Compare the Efficacy, Safety, Immunogenicity and Pharmacokinetics of Biosimilar Vedolizumab Injection in Patients with Moderate to Severe Active Ulcerative Colitis.