Efficacy and Safety of Vedolizumab in Biologic-naïve Korean Patients With Moderate to Severe Inflammatory Bowel Disease

NCT04919252 | Unknown Phase 3

• 1 other identifier: 4-2020-1365
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

If subjects voluntarily consent to participation in the study, those who are finally determined to be eligible for the study after whether all of the inclusion criteria and none of the exclusion criteria are met is checked will receive the study drug. Efficacy and safety will be evaluated at baseline, baseline, 2 weeks, 6 weeks, 14 weeks, 22 weeks, 30 weeks, 38 weeks, 46 weeks, and 54 weeks.

Conditions

Crohn's Disease and Ulcerative Colitis

Keywords

inflammatory bowel disease

Outcome Measures

Primary Outcomes (2)

• Clinical remission rate (%) at 14 weeks after commencement of vedolizumab treatment in induction phase

  Clinical remission is defined as Mayo score ≤ 2 points and individual score ≤ 1 point for Ulcerative colitis and CDAI(Crohn's Disease Activity Index) \< 150 for Crohn's Disease.

  14 weeks

• Clinical remission rate (%) at 54 weeks in maintenance phase

  Clinical remission is defined as Mayo score ≤ 2 points and individual score ≤ 1 point for Ulcerative colitis and CDAI(Crohn's Disease Activity Index) \< 150 for Crohn's Disease.

  54 weeks

Secondary Outcomes (12)

• Response rate of dose intensification at 54 weeks in inadequate responders at 6 weeks

  6 weeks, 54 weeks

• Mucosal healing rate at 14 weeks and 54 weeks

  14 weeks, 54 weeks

• Steroid free remission rate at 54 weeks

  54 weeks

• Transmural healing rate at 14 weeks and 54 weeks for Crohn's Disease

  14 weeks, 54 weeks

• Correlation of CRP(C-reactive protein) level with clinical remission at 54 weeks.

  54 weeks

Study Arms (1)

Vedolizumab

EXPERIMENTAL

* Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks. * Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks.

Drug: Vedolizumab

Interventions

Vedolizumab DRUG

* Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks. * Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks.

Vedolizumab

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥ 19 years to ≤ 70 years
• Patients with moderate-to-severe active Crohn's disease or ulcerative colitis who are unresponsive to, become unresponsive to, or have no tolerability to universal treatment (with corticosteroids, immunomodulators, etc.)
• CDAI (Crohn's Disease Activity Index) ≥ 220 for Crohn's disease
• Complete Mayo score ≥ 6 for ulcerative colitis

You may not qualify if:

• A history of total colectomy
• Acute severe UC(Ulcerative Colitis)
• A potential for a bowel resection surgery within 3 months
• Pregnancy and breastfeeding
• Prior use of any biologics including anti-TNFs, ustekinumab, and tofacitinib
• A history of solid cancer and blood cancer within 5 years
• Positive for active or latent tuberculosis (However, screening is possible if active tuberculosis is excluded and after at least 4 weeks of latent tuberculosis treatment.)
• Active severe infections such as sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
• Hypersensitivity to vedolizumab or its substances (e.g., dyspnoea, bronchospasm, redness, and increased heart rate)
• Experience of treatment with a drug or a medical device due to participation in another clinical trial within 3 months from the date of consent
• A woman of childbearing potential who has a positive pregnancy test (Urine-hCG or Serum hCG) at a screening visit or does not agree to use at least one of medically acceptable, effective contraceptive methods\*. However, females who reached menopause at least one year ago or turned out infertile due to an operation should be excluded.
• \*Effective contraceptive methods: intrauterine devices (e.g., IUD, mirena), dual barrier methods (diaphragm or condom/femidom + spermicide), and parenteral contraceptives. Continuing only sexual abstinence is not viewed as an acceptable method.
• A woman of childbearing potential who neither practices adequate contraception nor agrees to continue its use for at least 18 weeks after the last dose of the study drug.
• Those decided by the investigator to be not eligible for this study

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Jae hee Cheon, MD, PhD

  Severance Hospital of Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae hee Cheon, MD, PhD

CONTACT

82-2-2228-1990; geniushee@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: June 9, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)