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

NCT04804540 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: Vedolizumab-4020EUPAS23702
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Ulcerative Colitis; Crohn Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46

  At Weeks 14, 30 and 46

• Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46

  At Weeks 14, 30 and 46

• Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46

  At Weeks 14, 30 and 46

• Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46

  At Weeks 14, 30 and 46

• Percentage of UC and CD Participants Who Discontinued Vedolizumab

  From first dose of study drug up to Week 46

Study Arms (1)

Vedolizumab 300 mg

EXPERIMENTAL

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

Interventions

Vedolizumab IV DRUG

Vedolizumab IV infusion

Also known as: Kynteles

Vedolizumab 300 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
• Conventional therapy
• TNF-α alpha antagonist

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (17)

Government General Hospital

Guntur, Andhra Pradesh, 522001, India

Location

Institute of Gastroenterology and Liver Disease Dispur Hospitals

Guwahati, Assam, 781006, India

Location

Indira Gandhi Institute of Medical Sciences

Patna, Bihar, 800014, India

Location

Gastroplus Digestive Disease Centre Pvt.Ltd

Ahmedabad, Gujarat, 380054, India

Location

Surat Institute of Digestive Sciences

Surat, Gujarat, 395002, India

Location

Banglore Medical College & Research Institute

Bangalore, Karnatka, 560002, India

Location

Midas Multispeciality Hospital

Nagpur, Maharashtra, 440010, India

Location

Dr. Ram Manohar Lohia Hospita Hospital

New Delhi, National Capital Territory of Delhi, 110001, India

Location

Maulana Azad Medical college & Associated G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

Location

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Dayanand Medical College and Hospital

Ludhiana, Punjab, 141001, India

Location

VGM Hospital- Institute of Gastroenterology

Coimbatore, Tamil Nadu, 641005, India

Location

Asian Institute of Gastroenterology

Hyderabad, Telangana, 500082, India

Location

Yashoda Hospitals

Secunderabad, Telangana, 500003, India

Location

King George's Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Osmania General Hospital

Hyderabad, 500012, India

Location

Deccan College of Medical Sciences

Hyderabad, 500058, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: December 8, 2021
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

IN (17)