A Phase 3, Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-Controlled Induction Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Subjects in China With Moderately to Severely Active Crohn's Disease

Status: Recruiting
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University First Hospital - Changqiao Campus
COMPLETED
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Changzhou No.2 People's Hospital - Yanling Campus
RECRUITING
Changzhou
The First People's Hospital of Foshan
RECRUITING
Foshan
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Guangzhou First People's Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital, Sun Yat-sen University - Main
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The Third Affiliated Hospital, Sun Yat-Sen University
COMPLETED
Guangzhou
The 2nd Affliated Hospital of Harbin Medical University
RECRUITING
Haerbin
The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS
RECRUITING
Hangzhou
The Second Hospital of Anhui Medical University
RECRUITING
Hefei
Huizhou Central People's Hospital
RECRUITING
Huizhou
The First People's Hospital of Yunnan Province
RECRUITING
Kunming
Lanzhou University Second Hospital
RECRUITING
Lanzhou
The Second Affiliated Hospital of Nanchang University - Donghu Campus
RECRUITING
Nanchang
Zhongda Hospital, Affiliated to Southeast University
RECRUITING
Nanjing
Nanyang First People's Hospital
RECRUITING
Nanyang
The First Affiliated Hospital of Ningbo University - Fangqiao Campus
RECRUITING
Ningbo
Qingyuan People's Hospital
COMPLETED
Qingyuan
People's Hospital of Quzhou
COMPLETED
Quzhou
Shanghai Changhai Hospital
RECRUITING
Shanghai
Shanghai East Hospital - Main
RECRUITING
Shanghai
Zhongshan Hospital Fudan University
COMPLETED
Shanghai
Shengjing Hospital of China Medical University - Nanhu Campus
RECRUITING
Shenyang
The University of Hong Kong - Shenzhen Hospital
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University - Main
COMPLETED
Shijiazhuang
Changshu No.2 People's Hospital
RECRUITING
Suzhou
Taizhou Hospital of Zhejiang Province - Main
RECRUITING
Taizhou
The First People's Hospital of Wenling
RECRUITING
Taizhou
Tianjin Medical University General Hospital
RECRUITING
Tianjin
The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus
COMPLETED
Wenzhou
Renmin Hospital of Wuhan University - Main Campus
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Yijishan Hospital of Wannan Medical College
RECRUITING
Wuhu
Xuzhou Central Hospital
COMPLETED
Xuzhou
Yantai Yuhuangding Hospital
COMPLETED
Yantai
People's Hospital of Ningxia Hui Aotonomous Region
COMPLETED
Yinchuan
The Fifth Affiliated Hospital Sun Yat-Sen University
RECRUITING
Zhuhai
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2023-06-16
Estimated Completion Date: 2031-05-30
Participants
Target number of participants: 408
Treatments
Experimental: Induction Period: Vedolizumab 300 mg
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.
Placebo_comparator: Induction Period: Placebo
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.
Experimental: Open-label Extension (OLE) Period: Vedolizumab 300 mg
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.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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