A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease

A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn's Disease

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab.

At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment.

Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: Vedolizumab IV

Detailed Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have active UC or CD.

The study will enroll approximately 150 patients. Participants will be assigned to the vedolizumab treatment group.

•Vedolizumab 300 mg

Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2, 6 and 10 (CD-participants who have not shown a response can receive a dose at Week 10) during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.

This multicentre trial will be conducted in India. The overall time to participate in this study is 74 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit after receiving their last dose of drug for a follow-up assessment.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Hyderabad, India, 500012
    • Osmania General Hospital
  • Hyderabad, India, 500058
    • Deccan College of Medical Sciences
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Government General Hospital
  • Assam
    • Guwahati, Assam, India, 781006
      • Institute of Gastroenterology and Liver Disease Dispur Hospitals
  • Bihar
    • Patna, Bihar, India, 800014
      • Indira Gandhi Institute of Medical Sciences
  • Delhi
    • New Delhi, Delhi, India, 110029
      • All India Institute of Medical Sciences
    • New Delhi, Delhi, India, 110001
      • Dr. Ram Manohar Lohia Hospita Hospital
    • New Delhi, Delhi, India, 110002
      • Maulana Azad Medical college & Associated G B Pant Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380054
      • Gastroplus Digestive Disease Centre Pvt.Ltd
    • Surat, Gujarat, India, 395002
      • Surat Institute of Digestive Sciences
  • Karnatka
    • Bangalore, Karnatka, India, 560002
      • Banglore Medical College & Research Institute
  • Maharashtra
    • Nagpur, Maharashtra, India, 440010
      • MIDAS Multispeciality Hospital
  • Punjab
    • Ludhiana, Punjab, India, 141001
      • Dayanand Medical College and Hospital
  • Tamilnadu
    • Coimbatore, Tamilnadu, India, 641005
      • VGM Hospital- Institute of Gastroenterology
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Asian Institute of Gastroenterology
    • Secunderabad, Telangana, India, 500003
      • Yashoda Hospitals
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • King George's Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of >=8 for CD at the time of enrolment.

2. Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:

   1. Conventional therapy
   2. TNF-α alpha antagonist

Exclusion Criteria:

1. Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
2. Has active or latent tuberculosis (TB).
3. Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
4. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vedolizumab 300 mg; Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2 and 6 during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase.	Drug: Vedolizumab IV; Vedolizumab IV infusion; Other Names: Kynteles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	AE was defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with the treatment. AE can therefore be any unfavourable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with use of a drug, whether or not it is considered related to the drug. A SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI (serious or nonserious) was one of scientific and medical concern specific to the compound or program.	From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs	An ADR was an AE for which there was at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. An unexpected ADR was an ADR with the nature, severity, or outcome which was not consistent with the product insert.	From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46	Clinical response for UC participants was defined as decrease in Simple Clinical Colitis Activity Index (SCCAI) of greater than and equal to (>=) 3 from baseline or by physician assessment of clinical response. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity.	At Weeks 14, 30 and 46
Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46	Clinical response for CD participants was defined as decrease in Harvey Bradshaw Index (HBI) of >= 3 points from baseline. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score < 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease. A higher score indicated a worse outcome.	At Weeks 14, 30 and 46
Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46	Clinical remission for UC participants was defined as decrease in SCCAI of less than and equal to (<=) 2 with no individual score > 1. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity.	At Weeks 14, 30 and 46
Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46	Clinical remission for CD participants was defined as HBI of <= 4. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score < 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and >16 severe disease. A higher score indicated a worse outcome.	At Weeks 14, 30 and 46
Percentage of UC and CD Participants Who Discontinued Vedolizumab	Vedolizumab discontinuation was defined as ceasing vedolizumab, or a treatment gap >= 90 days between consecutive doses.	From first dose of study drug up to Week 46
Percentage of UC Participants With Mucosal Healing at Week 46	Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Mayo endoscopic sub-score of <=1 point. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranged from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 were considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, with higher scores indicated more severe disease.	At Week 46
Percentage of CD Participants With Mucosal Healing at Week 46	Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Simple Endoscopic Score for Crohn Disease (SES-CD) 0-2 or SES-CD <=4 and at least a 2-point reduction from baseline with no sub-score >1. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease.	At Week 46
Percentage of UC Participants With Endoscopic Response at Week 46	Endoscopic response was defined as decrease in Mayo endoscopic sub-score of >=1 point in UC participants. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, where higher scores indicated more severe disease.	At Week 46
Percentage of CD Participants With Endoscopic Response at Week 46	Endoscopic response was defined as > 50% decrease in SES-CD in CD participants. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranged from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease.	At Week 46
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46	The SIBDQ was a valid and reliable instrument used to assess quality of life in adult participants with Inflammatory Bowel Disease (IBD). It was a 10-item questionnaire that included questions on 4 domains of health-related quality of life (HRQoL): bowel systems, emotional function, social function, and systemic function and was scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). A total SIBDQ score was calculated by summing the scores from each domain; the total SIBDQ score ranged from 10 (poor HRQoL) to 70 (optimum HRQoL). Higher values of SIBDQ represented a better quality of life.	Baseline, Weeks 14, 30 and 46

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Medical Director, Takeda

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Actual): February 2, 2024
• Study Completion (Actual): February 2, 2024

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Crohn Disease; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: Vedolizumab-4020; EUPAS23702 (Other Identifier: ENCePP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes