Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.

Last updated: February 28, 2023
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Colic

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT03234907
Vedolizumab-3034
U1111-1195-3932
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has a diagnosis of Crohn's disease (CD) established at least 3 months prior toScreening by clinical and endoscopic evidence corroborated by a histopathology report.Cases of CD established at least 6 months prior to randomization for which ahistopathology report is not available will be considered based on the weight ofevidence supporting the diagnosis and excluding other potential diagnosis, and must bediscussed with the sponsor on a case-by-case basis prior to randomization.
  2. Has moderately to severely active CD as determined by a Crohn's Disease Activity Index (CDAI) score of 220 to 400 within 7 days prior to the first dose of study drug and 1of the following:
  • C-reactive protein (CRP) level >2.87 mg/L during the Screening Phase, OR
  • Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomoticulcerations (each >0.5 cm in diameter) or 10 aphtous ulcerations (involving aminimum of 10 contiguous cm of intestine) consistent with CD, within 4 monthsprior to randomization, OR
  • Fecal calprotectin >250 μg/g stool during the Screening Phase in conjunction withcomputed tomography enterography (CTE), magnetic resonance enterography (MRE),contrast enhanced small bowel radiography, or wireless capsule endoscopyrevealing CD ulcerations (aphthae not sufficient), within 4 months prior toScreening
  1. Has CD involvement of the ileum and/or colon, at a minimum.
  2. Has extensive colitis or pancolitis of >8 years duration or limited colitis of >12years duration must have documented evidence that a surveillance colonoscopy wasperformed within 12 months prior to initial screening (may be performed duringScreening if not performed in previous 12 months).
  3. Has a family history of colorectal cancer, personal history of increased colorectalcancer risk, age >50 years, or other known risk factor must be up-to-date oncolorectal cancer surveillance (may be performed during Screening).
  4. Has demonstrated an inadequate response to, loss of response to, or intolerance of atleast 1 of the following agents as defined below:
  • Corticosteroids.
  • Immunomodulators.
  • Tumor necrosis factor-alpha (TNF-α) antagonists.

Exclusion

Exclusion Criteria:

  1. Has evidence of abdominal abscess at the initial Screening Visit.
  2. Has had extensive colonic resection, subtotal or total colectomy.
  3. Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
  4. Has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, orevidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.
  5. Has had previous exposure to approved or investigational anti-integrins (e.g.,natalizumab, efalizumab, etrolizumab, or AMG-181), or MAdCAM-1 antagonists, orrituximab.
  6. Has used topical (rectal) treatment with 5-ASA, corticosteroid enemas/suppositories ortraditional Chinese medications for CD treatment within 2 weeks of the administrationof the first dose of study drug.
  7. Requires currently or is anticipated to require surgical intervention for CD duringthe study.
  8. Has a history or evidence of adenomatous colonic polyps that have not been removed.
  9. Has a history or evidence of colonic mucosal dysplasia including low or high-gradedysplasia, as well as indeterminate for dysplasia.
  10. Has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,ischemic colitis, and radiation colitis.
  11. Has evidence of treatment for C.difficile infection or other intestinal pathogen with 28 days prior to first dose of study drug.
  12. Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)infection.
  13. Has active or latent tuberculosis.
  14. Has any identified congenital or acquired immunodeficiency (e.g., common variableimmunodeficiency, human immunodeficiency virus [HIV] infection, organtransplantation).
  15. Has any history of malignancy, except for the following: (a) adequately-treatednonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has beenadequately treated and that has not recurred for at least 1 year prior torandomization; and (c) history of cervical carcinoma in situ that has been adequatelytreated and that has not recurred for at least 3 years prior to randomization.Participants with remote history of malignancy (e.g., >10 years since completion ofcurative therapy without recurrence) will be considered based on the nature of themalignancy and the therapy received and must be discussed with the sponsor on acase-by-case basis prior to randomization.
  16. Has a history of any major neurological disorders, including stroke, multiplesclerosis, brain tumor, or neurodegenerative disease.
  17. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptomchecklist at Screening or prior to the administration of the first dose of study drugat Week 0.

Study Design

Total Participants: 215
Study Start date:
August 03, 2017
Estimated Completion Date:
August 14, 2020

Study Description

The drug being tested in this study is called vedolizumab. Vedolizumab will be administered as an intravenous (IV) infusion in Chinese participants. This study will investigate the efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants with moderately to severely active Crohn's Disease (CD).

The study will enroll approximately 300 moderately to severely active Chinese patients with CD.

Induction Phase: participants will be randomized 2:1 to receive:

  • Vedolizumab IV 300 mg

  • Placebo IV

Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for clinical response. Results of Week 10 clinical response will determine the treatment pathway in the maintenance phase.

Maintenance Phase: participants who achieved clinical response at Week 10 will continue to receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W) starting at Week 14.

This multi-center trial will be conducted in China. The overall time to participate in this study is 60 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long-term follow-up safety survey.

Connect with a study center

  • Gastroenterology

    Hefei, Anhui 230024
    China

    Site Not Available

  • Gastroenterology

    Beijing, Beijing 100050
    China

    Site Not Available

  • Gastroenterology

    Chongqing, Chongqing 400037
    China

    Site Not Available

  • Gastroenterology

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • Gastroenterology

    Xiamen, Fujian 361004
    China

    Site Not Available

  • Gastroenterology

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Gastroenterology

    Wuhan, Hubei 430060
    China

    Site Not Available

  • Gastroenterology

    Changsha, Hunan 410013
    China

    Site Not Available

  • Gastroenterology

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Gastroenterology

    Wuxi, Jiangsu 241023
    China

    Site Not Available

  • Gastroenterology

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Gastroenterology

    Changchun, Jilin 130000
    China

    Site Not Available

  • Gastroenterology

    Shenyang, Liaoning 110022
    China

    Site Not Available

  • Gastroenterology

    Shanghai, Shanghai 200092
    China

    Site Not Available

  • Gastroenterology

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Gastroenterology

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Gastroenterology

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Gastroenterology

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

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