A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

NCT04738942 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: Vedolizumab-3039U1111-1262-7325jRCT2031200371
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 20

Brief Summary

The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). Vedolizumab is commercially available in Japan for 8-weekly treatment but not for 4-weekly treatment. The study doctors will also monitor side effects from the study treatment. This study will take place in Japan. At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will receive vedolizumab intravenously once every 4 weeks. After 3 infusions of vedolizumab (which will be 12 weeks of treatment), the study doctor will assess if symptoms of the participants have improved. Participants who do not have improved symptoms after 12 weeks of treatment with vedolizumab will stop this treatment. Then, they will visit the study clinic 16 weeks after their last infusion of vedolizumab for a final check-up. Participants who have improved symptoms after 12 weeks of treatment with vedolizumab will continue to receive vedolizumab every 4 weeks. Then, after their last infusion of vedolizumab, the participants will visit the study clinic 16 weeks later for a final check-up. Finally, the study clinic will make a phone call to each participant 6 months after their last infusion to check if they have any health problems.

Conditions

Ulcerative Colitis; Crohn's Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants with Clinical Response at Week 12 Based on Modified Mayo Score in UC Cohort

  Clinical response is defined as a reduction of \>=2 points and \>=25% in modified Mayo score, and a decrease of \>=1 point in rectal bleeding subscore or rectal bleeding subscore of =\<1 from baseline (Week 0). Mayo score is an instrument designed to measure disease activity of UC. Modified Mayo score consists of 3 sub-scores: stool frequency, rectal bleeding, and Mayo endoscopic subscore (findings on endoscopy), each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher score indicates more severe disease.

  Week 12

• Percentage of Participants with Clinical Response at Week 12 in CD Cohort

  Clinical response is defined as a reduction of =\>70 points in CDAI score from baseline (Week 0). CDAI assesses CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general well being, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease.

  Week 12

Secondary Outcomes (6)

• Percentage of Participants with Clinical Remission at Week 12 Based on Modified Mayo Score in UC Cohort

  Week 12

• Percentage of Participants with Mucosal Healing at Week 12 in UC Cohort

  Week 12

• Percentage of Participants with Corticosteroid-Free Remission Based on Partial Mayo Score in UC Cohort

  Week 12

• Percentage of Participants with Clinical Remission at Week 12 in CD Cohort

  Week 12

• Percentage of Participants with Enhanced Clinical Response at Week 12 in CD Cohort

  Week 12

Study Arms (2)

Vedolizumab 300 mg in UC cohort

EXPERIMENTAL

Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase.

Drug: Vedolizumab

Vedolizumab 300 mg in CD cohort

EXPERIMENTAL

Vedolizumab 300 mg, IV infusion, for up to 12 weeks Q4W for Treatment phase, and until the date of marketing approval of vedolizumab IV Q4W or study termination for Extension phase.

Drug: Vedolizumab

Interventions

Vedolizumab DRUG

Vedolizumab 300 mg, IV infusion

Vedolizumab 300 mg in CD cohort; Vedolizumab 300 mg in UC cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• UC cohort
• The participant has moderate to severe UC, who had previously shown clinical response in initial treatment with commercially available vedolizumab IV, then experienced secondary loss of response during maintenance therapy with commercially available vedolizumab IV Q8W.
• Previous "clinical response" is to be judged by the investigators referring to one of the following criteria.
• Reduction of \>=2 points and \>=25% in modified Mayo score, and a decrease of \>=1 point in rectal bleeding subscore or rectal bleeding subscore of =\<1, from the start of initial treatment with commercially available vedolizumab IV.
• Reduction of \>=2 points and \>=25% in partial Mayo score, and a decrease of \>=1 point in rectal bleeding subscore or rectal bleeding subscore of =\<1, from the start of initial treatment with commercially available vedolizumab IV.
• Significant improvement on endoscopy (i.e., a decrease of \>=2 points in Mayo endoscopic subscore).
• "Secondary loss of response" is to be judged by the investigators referring to one of the following criteria.
• Increase of \>=2 points in modified Mayo score, and an increase of \>=1 point in rectal bleeding subscore or rectal bleeding subscore \>=2, from the start of maintenance therapy with commercially available vedolizumab IV.
• Increase of \>=2 points in partial Mayo score, and an increase of \>=1 point in rectal bleeding subscore or rectal bleeding subscore \>=2, from the start of maintenance therapy with commercially available vedolizumab IV.
• Significant deterioration on endoscopy (i.e., an increase of \>=2 points in Mayo endoscopic subscore).
• The participant has active UC as determined by a modified Mayo score of \>=5 at baseline (within 10 days prior to the start of treatment phase), with a Mayo rectal bleeding subscore of \>=1 at baseline (within 10 days prior to the start of treatment phase) and a Mayo endoscopic subscore of \>=1 as assessed by the central reader.
• CD cohort
• The participant has moderate to severe CD, who had previously shown clinical response in initial treatment with commercially available vedolizumab IV, then experienced secondary loss of response during maintenance therapy with commercially available vedolizumab IV Q8W.
• Previous "clinical response" is to be judged by the investigators referring to one of the following criteria.
• Reduction of \>=70 points in CDAI score from the start of initial treatment with commercially available vedolizumab IV.

You may not qualify if:

• The participant has had extensive colonic resection, subtotal or total colectomy.
• The participant has received any of the investigational or approved non-biologic therapies (e.g., cyclosporine, tacrolimus or tofacitinib, except for those specifically listed as permitted medications) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
• The participant has received any investigational or approved biologic or biosimilar agent other than vedolizumab within 60 days or 5 half-lives of screening (whichever is longer).
• The participant has a clinically significant active infection (e.g., pneumonia, pyelonephritis or coronavirus disease 2019 \[COVID-19\]) within 30 days prior to screening or during screening, or has an ongoing chronic infection.
• The participant has known or suspected intolerance or hypersensitivity to vedolizumab or closely related compounds, or any of the vedolizumab IV excipients.
• The participant has active cerebral/meningeal disease, or signs/symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML at screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (20)

Ieda Hospital

Toyota, Aichi-ken, Japan

Location

Hirosaki University Hospital

Hirosaki, Aomori, Japan

Location

Tsujinaka Hospital

Kashiwa, Chiba, Japan

Location

Toho University Sakura Medical Center

Sakura, Chiba, Japan

Location

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Location

Sapporo Kosei General Hospital

Sapporo, Hokkaido, Japan

Location

Hyogo College of Medicine Hospital

Nishinomiya, Hyōgo, Japan

Location

Ofuna Chuo Hospital

Kamakura, Kanagawa, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Location

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Location

Institute of Science Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Location

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Tokyo Yamate Medical Center

Shinjuku-ku, Tokyo, Japan

Location

Infusion Clinic.

Osaka, Japan

Location

Osaka Metropolitan University Hospital

Osaka, Japan

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 4, 2021
• Study Start: June 4, 2021
• Primary Completion: May 30, 2025
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

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

JP (20)