UMIN-CTR Clinical Trial

Public title

A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis

Acronym

A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis

Scientific Title

A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis

Scientific Title:Acronym

A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis

Region

Japan

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Primary Objective:
To evaluate endoscopic changes induced by vedolizumab IV by LCI classification at Week 22 in subjects with moderately to severely active UC.
Secondary Objectives:
To evaluate relationships between LCI classification and clinical remission, mucosal healing or histological remission at Weeks 22 and 54.
To evaluate relationships between LCI index and clinical remission, mucosal healing or histological remission at Weeks 22 and 54.
Exploratory Objective:
To investigate changes in various factors potentially related to changes induced by vedolizumab from baseline at Weeks 22 and 54.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

- LCI classification at Week 22

Key secondary outcomes

- LCI classification at Week 54
- LCI index at Weeks 22 and 54
- Proportion of subjects with clinical remission, mucosal healing and histologic remission at Weeks 22 and 54
- Association between LCI classification and clinical remission, mucosal healing or histologic remission at Weeks 22 and 54
- Association between changes in LCI classification from Week 0 (baseline) to Week 22 and clinical remission, mucosal healing or histologic remission at Week 22
- Association between changes in LCI classification from Week 0 (baseline) to Weeks 22 or 54, and clinical remission, mucosal healing or histologic remission at Week 54
- Association between changes in LCI classification from Week 22 to Week 54 and clinical remission, mucosal healing or histologic remission at Week 54
- Relationship between LCI index and clinical remission, mucosal healing or histologic remission at Weeks 22 and 54
- Relationship between changes in LCI index from Week 0 (baseline) to Week 22 and clinical remission, mucosal healing or histologic remission at Week 22
- Relationship between changes in LCI index from Week 0 (baseline) to Weeks 22 or 54, and clinical remission, mucosal healing or histologic remission at Week 54
- Relationship between changes in LCI index from Week 22 to Week 54 and clinical remission, mucosal healing or histologic remission at Week 54

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Main Criteria for Inclusion:
[Subjects with UC]
-Subjects with a diagnosis of UC at least 3 months prior to informed consent
-Subjects who have been scheduled to receive initial administration of vedolizumab IV
-Subjects with a partial Mayo score of 5 to 9, inclusive, at screening
-Subjects who meet the following treatment failure criteria with at least one of the following agents:
>Resistant, dependent, or intolerant to corticosteroids
>Refractory or intolerant to immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)or 5-ASA
>Inadequate response, loss of response, or intolerance to biological agents (anti-TNFa antibodies or ustekinumab) or tofacitinib
-Subjects aged 18 to 80 years, inclusive, at informed consent
[Subjects without UC]
-Subjects who have been scheduled to undergo colonoscopy for disease monitoring following resection of colonic adenomas and/or hyperplastic polyps
-Subjects aged 18 to 80 years, inclusive, at informed consent

Key exclusion criteria

[All subjects]
1.Subjects with a history of extensive colonic resection, subtotal or total colectomy
2.Subjects with a history of ileostomy, colostomy, or symptomatic intestinal stricture
[Subjects with UC]
1.Subjects with UC that are classified as predominant proctitis
2.Subjects who had received any of the following drugs within the designated period prior to the initial administration of vedolizumab: infliximab (8 weeks), adalimumab (2 weeks), golimumab (4 weeks), tofacitinib (1 week), and ustekinumab (8 weeks)
3.Subjects with prior exposure to vedolizumab, natalizumab, efalizumab or anti-CD20 antibodies (e.g., rituximab, ofatumumab and obinutuzumab)
4.Subjects with any evidence of an active infection within 1 month prior to the first administration of vedolizumab
5.Subjects previously diagnosed as having PML or subjects with symptoms suggestive of PML
6.Subjects with concurrent malignancies who are deemed unsuitable for enrollment by the investigator (e.g., Eastern Cooperative Oncology Group performance status of 2 or more, or are receiving cytotoxic chemotherapy, molecularly targeted therapy, or immune checkpoint inhibitors)
7.Subjects with a history of hypersensitivity reaction to vedolizumab or its components (subjects with contraindication in the vedolizumab package insert)
8.Subjects who are pregnant, are susceptible to being pregnant, are planning to be pregnant, or are lactating
[Subjects without UC]
1.Subjects with inflammatory bowel diseases, autoimmune disorders or connective tissue diseases

Target sample size

60

Name of lead principal investigator

1st name	Tomohisa
Middle name
Last name	Takagi

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Medical Frontier Development

Zip code

602-8566

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan

TEL

075-251-5519

Email

takatomo@koto.kpu-m.ac.jp

Name of contact person

1st name	Kazuhiko
Middle name
Last name	Uchiyama

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan

TEL

075-251-5519

Homepage URL

Email

k-uchi@koto.kpu-m.ac.jp

Institute

Kyoto Prefectural University of Medicine
Department of Molecular Gastroenterology and Hepatology

Institute

Department

Personal name

Organization

Takeda Pharmaceutical Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

- Setsunan University
- Institute of Physical and Chemical Research(RIKEN)

Name of secondary funder(s)

Organization

Kyoto Prefectural University of Medicine Institutional Review Board

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan

Tel

075-251-5111

Email

rinri@koto.kpu-m.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

・京都府立医科大学附属病院（京都府）
・京都府立医科大学附属北部医療センター（京都府）
・藤田胃腸科病院（大阪府）

Date of disclosure of the study information

2021

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2020

Year

11

Month

22

Day

Date of IRB

2021

Year

09

Month

15

Day

Anticipated trial start date

2021

Year

10

Month

21

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Plan
This is an open-label study to evaluate endoscopic changes induced by vedolizumab 300 mg intravenous (IV) infusion using linked color imaging (LCI) over a 46-week treatment period in Japanese patients with moderately to severely active ulcerative colitis (UC). Thirty subjects will be enrolled and relationships between LCI classification and clinical remission by complete Mayo score, LCI classification and mucosal healing by Mayo endoscopic subscore, and LCI classification and histological remission by Nancy histological index are evaluated at Weeks 22 and 54 of treatment. LCI classification is defined by assigning one of the three following categories to the region of colonic mucosa with the strongest degree of inflammation at each endoscopy: A (no redness), B (redness with visible vessels), or C (redness without visible vessels). Similar evaluations will be conducted using LCI index, which is an assessment of the redness of the inflamed mucosa that is defined as the Commission Internationale de l'Eclairage (CIE) a* value of a 40-pixel square area within the captured endoscopic image that displays the region of colonic mucosa with the strongest degree of inflammation at each endoscopy. This study will also evaluate as exploratory outcomes various factors potentially related to changes induced by vedolizumab. To this end, 30 subjects without UC will additionally be enrolled as a reference arm. Subjects without UC will undergo assessments at Week 0 and exit the study immediately without receiving vedolizumab.
The definitions in the study are provided below;
Clinical remission:Complete Mayo score is 2 or less and all subscores are 1 or less
Mucosal healing:Mayo endoscopic subscore is 1 or less
Histologic remission:Nancy histological index is 1 or less

Registered date

2020

Year

12

Month

25

Day

Last modified on

2023

Year

02

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048756