A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease

NCT05837897 | Recruiting Phase 3 FDA Drug

• 1 other identifier: Vedolizumab-3040
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 41

Brief Summary

This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks. There will be up to 20 study visits over 58 weeks to complete assessments.

Conditions

Crohn's Disease

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Clinical Response at Week 14

  Clinical response is defined as ≥8 point decrease in 2-component patient-reported outcome (PRO2) score from baseline. The PRO2 is constituted by abdominal pain and number of liquid stools components of the Crohn's Disease Activity Index (CDAI). The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of liquid or very soft stools and abdominal pain score (with 0 indicating no pain and 3 indicating severe pain) are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain).

  Up to Week 14

Secondary Outcomes (7)

• Percentage of Participants Achieving Clinical Remission at Week 14

  Up to Week 14

• Percentage of Participants Achieving Endoscopic Response at Week 14

  Up to Week 14

• Percentage of Participants Achieving Both Clinical Response and Endoscopic Response at Week 14

  Up to Week 14

• Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Discontinuation

  From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks)

• Percentage of Participants With Abnormal Change from Baseline in Vital Sign Values

  From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks)

Study Arms (3)

Induction Period: Vedolizumab 300 mg

EXPERIMENTAL

Participants will receive vedolizumab 300 mg IV infusion on Days 1,15, and 43 (Weeks 0, 2, and 6) in the 14-week Induction Period.

Drug: Vedolizumab IV

Induction Period: Placebo

PLACEBO COMPARATOR

Participants will receive vedolizumab placebo-matching IV, infusion on Days 1,15, and 43 (Weeks 0, 2, and 6) in the 14-week Induction Period.

Drug: Placebo

Open-label Extension (OLE) Period: Vedolizumab 300 mg

EXPERIMENTAL

All participants completing the Week 14 visit, irrespective of their response status, will continue in the OLE without unblinding of their baseline treatment group and will receive vedolizumab 300 mg, IV infusion, Q8W, on Days 99, 155, 211, 267, 323, and 379 (Weeks 14, 22, 30, 38, 46 and 54). Starting from Day 127 (Week 18) until the end of OLE Period up to approximately 58 weeks, participants who are nonresponders or who have disease worsening are eligible to receive 300 mg vedolizumab Q4W.

Drug: Vedolizumab IV

Interventions

Vedolizumab IV DRUG

Vedolizumab IV infusion

Induction Period: Vedolizumab 300 mg; Open-label Extension (OLE) Period: Vedolizumab 300 mg

Placebo DRUG

Vedolizumab placebo-matching IV infusion

Induction Period: Placebo

Eligibility Criteria

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

You may qualify if:

• The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of CD established at least 6 months before randomization for which a histopathology report is not available will be considered based on the weight of evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor on a case-by-case basis before randomization.
• The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4 in cases of isolated ileitis) on screening ileocolonoscopy.
• The participant has CD involvement of the ileum and/or colon, at a minimum.
• A participant with extensive colitis or pancolitis of \>8 years duration or limited colitis of \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before initial screening (may be performed during screening if not performed in previous 12 months).
• A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).
• The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
• Corticosteroids.
• Immunomodulators.
• TNF-α antagonists.

You may not qualify if:

• The participant has evidence of abdominal abscess at the initial screening visit.
• The participant has had extensive colonic resection, subtotal or total colectomy.
• The participant has a history of \>3 small bowel resections or diagnosis of short bowel syndrome.
• The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose of study drug.
• The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
• Within 30 days before randomization, the participant has received any of the following for the treatment of underlying disease:
• Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in the Permitted Medications and Treatments section.
• An approved or investigational nonbiologic therapy in an investigational protocol.
• The participant has received traditional Chinese medication (TCMs) within 30 days before randomization.
• The participant has had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or abrilumab (AMG-181), or mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1) antagonists, or rituximab.
• The participant has had previous exposure to vedolizumab.
• The participant has used topical (rectal) treatment with 5-aminosalicylic acid (5-ASA), corticosteroid enemas/suppositories or traditional Chinese medications for CD treatment within 2 weeks of the administration of the first dose of study drug.
• The participant requires currently or is anticipated to require surgical intervention for CD during the study.
• The participant has a history or evidence of adenomatous colonic polyps that have not been removed.
• The participant has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia.

Sponsors & Collaborators

• Takeda: lead

Study Sites (41)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

RECRUITING

Yijishan Hospital of Wannan Medical College

Wuhu, Anhui, 241001, China

RECRUITING

Peking University First Hospital - Changqiao Campus

Beijing, Beijing Municipality, 100034, China

COMPLETED

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

RECRUITING

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University - Main

Guangzhou, Guangdong, 510080, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

COMPLETED

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Huizhou Central People's Hospital

Huizhou, Guangdong, 516001, China

RECRUITING

Qingyuan People's Hospital

Qingyuan, Guangdong, 511518, China

COMPLETED

The University of Hong Kong - Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

RECRUITING

The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

The Second Hospital of Hebei Medical University - Main

Shijiazhuang, Hebei, 50051, China

COMPLETED

The 2nd Affliated Hospital of Harbin Medical University

Haerbin, Heilongjiang, 150081, China

RECRUITING

Nanyang First People's Hospital

Nanyang, Henan, 474500, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Renmin Hospital of Wuhan University - Main Campus

Wuhan, Hubei, 430060, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Changzhou No.2 People's Hospital - Yanling Campus

Changzhou, Jiangsu, 213200, China

RECRUITING

Zhongda Hospital, Affiliated to Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Changshu No.2 People's Hospital

Suzhou, Jiangsu, 215516, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

COMPLETED

The Second Affiliated Hospital of Nanchang University - Donghu Campus

Nanchang, Jiangxi, 330008, China

RECRUITING

Shengjing Hospital of China Medical University - Nanhu Campus

Shenyang, Liaoning, 110004, China

RECRUITING

People's Hospital of Ningxia Hui Aotonomous Region

Yinchuan, Ningxia, 750002, China

COMPLETED

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

COMPLETED

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200022, China

COMPLETED

Shanghai East Hospital - Main

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650100, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS

Hangzhou, Zhejiang, 310003, China

RECRUITING

The First Affiliated Hospital of Ningbo University - Fangqiao Campus

Ningbo, Zhejiang, 315010, China

RECRUITING

People's Hospital of Quzhou

Quzhou, Zhejiang, 324307, China

COMPLETED

Taizhou Hospital of Zhejiang Province - Main

Taizhou, Zhejiang, 317000, China

RECRUITING

The First People's Hospital of Wenling

Taizhou, Zhejiang, 317599, China

RECRUITING

The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus

Wenzhou, Zhejiang, 325000, China

COMPLETED

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 1, 2023
• Study Start: June 16, 2023
• Primary Completion (Estimated): March 8, 2030
• Study Completion (Estimated): May 30, 2031
• Last Updated: November 5, 2025

Record last verified: 2025-11

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

CN (41)