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New treatment option for Crohn's Disease
Official title A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
ClinicalTrials.gov ID: NCT06045754
What this study is testing
What is Vedolizumab?
Vedolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn's disease.
Also referred to as Entyvio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Inadequate response after completing the full induction regimen;
You likely can't join if
- 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.
See the full eligibility 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...
- In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Sun City, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Hamden, Connecticut, United States
- Kissimmee, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Roswell, Georgia, United States
- Chicago, Illinois, United States
- Glenview, Illinois, United States
- Gurnee, Illinois, United States
- Kansas City, Kansas, United States
- Topeka, Kansas, United States
- Louisville, Kentucky, United States
- Metairie, Louisiana, United States
- New Orleans, Louisiana, United States
- Ypsilanti, Michigan, United States
- Kansas City, Missouri, United States
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Sun City, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Hamden, Connecticut, United States and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.