A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Recruiting · NCT06045754 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Part A:
- Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.
- Has moderately to severely active CD at Screening, defined as an SES-CD \>=6 (\>=4 if isolated ileal disease).
- Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:
- Inadequate response after completing the full induction regimen;
- Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
- Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).
- Note: Participants with an inadequate response to \>2 classes of advanced therapies or \>1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.
- Part B:
- In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.
Exclusion criteria
- CDAI score \> 450.
- A current diagnosis of ulcerative colitis or indeterminate colitis.
- Clinical evidence of an abdominal abscess.
- Known fistula (other than perianal fistula) or phlegmon.
- Known perianal fistula with abscess.
- Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
- Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
- Short bowel syndrome.
- Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.
- History or evidence of adenomatous colonic polyps that have not been removed.
- History or evidence of colonic mucosal dysplasia.
- Intolerance or contraindication to ileocolonoscopy.
- Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).
- Active or latent tuberculosis (TB), regardless of treatment history.
- A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.
- A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).
- Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\], anti- mucosal addressin cell adhesion molecule-1 \[MAdCAM-1\] antibodies, or rituximab) for the treatment of CD.
- History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee. If the PML IAC deems the participant to have PML, the participant is ineligible.
Where it is running
48 locations listed across 21 US states.
- Digestive Health Specialsits - Dothan, Alabama, United States
- GI Alliance Sun City - Sun City, Arizona, United States
- University of California San Diego Health (UCSD) - La Jolla, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Hoag Hospital Newport Beach - Newport Beach, California, United States
- Medical Research Center of Connecticut, LLC - Hamden, Connecticut, United States
- Clinical Research of Osceola - Kissimmee, Florida, United States
- Endoscopic Research Inc - Orlando, Florida, United States
- Alliance Clinical Research of Tampa, LLC - Tampa, Florida, United States
- Gastroenterology Consultants, P.C. - Roswell, Georgia, United States
- University of Chicago Medicine - Chicago, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Cotton ONeil Clinical Research Center - Topeka, Kansas, United States
- University of Louisville - Louisville, Kentucky, United States
- GI Alliance - Metairie, Louisiana, United States
- Tulane University - New Orleans, Louisiana, United States
- Huron Gastroenterology Associates, P.C. - Ypsilanti, Michigan, United States
- Mid-America Gastro-Intestinal Consultants - Kansas City, Missouri, United States
- BVL Clinical Research - Liberty, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- NYU Langone Health - New York, New York, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- Ohio Gastroenterology group, Inc. - Columbus, Ohio, United States
- Great Lakes Gastroenterology Research, LLC - Mentor, Ohio, United States
- Gastro Intestinal Research Institute of Northern Ohio, LLC. - Westlake, Ohio, United States
- Digestive Disease Specialists, Inc. - Oklahoma City, Oklahoma, United States
- Allegheny Health Network - Wexford, Pennsylvania, United States
- University Gastroenterology - Providence, Rhode Island, United States
- Sanford Health Research - Rapid City, South Dakota, United States
- Texas Digestive Disease Consultants Cedar Park - Cedar Park, Texas, United States
- GI Alliance - Digestive Health Associates of Texas - Dallas, Texas, United States
- The University of Texas Health Science Center at Houston - Houston, Texas, United States
- Texas Digestive Disease Consultants Lubbock - Lubbock, Texas, United States
- GI Alliance - Mansfield - Mansfield, Texas, United States
- Gastroenterology Research of San Antonio, LLC - San Antonio, Texas, United States
- Southern Star Research Institute, LLC. - San Antonio, Texas, United States
- Texas Digestive Disease Consultants (TDDC), Southlake - Southlake, Texas, United States
- Tyler Research Institute, LLC - Tyler, Texas, United States
- GI Alliance - Webster - Webster, Texas, United States
- University of Utah Health - Salt Lake City, Utah, United States
- Washington Gastroenterology- GIA - Tacoma, Washington, United States
- Covenant Health - Edmonton, Alberta, Canada
- London Health Sciences Centre - London, Ontario, Canada
- Viable Clinical Research - North Bay - North Bay, Ontario, Canada
- Toronto Immune and Digestive Health Institute Inc. (TIDHI) - North York, Ontario, Canada
- ABP Research Services Corp. - Oakville, Ontario, Canada
- Toronto Digestive Disease Associates (TDDA) Inc. - Vaughan, Ontario, Canada
- The Research Institute of the McGill University Health Centre - Montreal, Quebec, Canada