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New treatment option for Ulcerative Colitis
Official title A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
ClinicalTrials.gov ID: NCT06581328
What this study is testing
What is Vedolizumab IV?
Vedolizumab IV is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ulcerative colitis.
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
- Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).
- Phase 4: studies an already-approved treatment
- Time commitment: about 1 year
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 80
You may be able to join if
- To be eligible to participate in this study, participants must meet all the following criteria:
- In the investigator's opinion, the participant can understand and comply with protocol requirements.
- The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.
- The participant is 18 to 80 years of age at the time of signing the ICF.
- The participant's immunization is up to date per vedolizumab US prescribing information (USPI).
You likely can't join if
- Participants who meet any of the following exclusion criteria will be excluded from participation in this study:
- Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any...
- Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.
- Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).
- In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population...
- Received any investigational biologic therapy \<= 6 months prior to screening.
See the full eligibility criteria
- To be eligible to participate in this study, participants must meet all the following criteria:
- In the investigator's opinion, the participant can understand and comply with protocol requirements.
- The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.
- The participant is 18 to 80 years of age at the time of signing the ICF.
- The participant's immunization is up to date per vedolizumab US prescribing information (USPI).
- If participant is a woman of childbearing potential (WOCBP):
- Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.
- Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.
- Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.
- Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.
- If participant is a fertile man:
- Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab
- Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.
- The participant has a diagnosis of moderate to severely active UC or CD defined by the following:
- CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR
- UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening
- UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
- Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy.
- Participants who meet any of the following exclusion criteria will be excluded from participation in this study:
- Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab [AMG 181]) at any time prior to screening.
- Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.
- Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).
- In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known...
- Received any investigational biologic therapy \<= 6 months prior to screening.
- The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12/23 antagonist...
- The participant has any evidence of an active infection during screening.
- Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.
- A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.
- History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to...
- History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.
- Has laboratory abnormalities during the screening period.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Sun City, Arizona, United States
- Little Rock, Arkansas, United States
- Escondido, California, United States
- Murrieta, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Littleton, Colorado, United States
- Brooksville, Florida, United States
- Clearwater, Florida, United States
- Hialeah, Florida, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
+ 71 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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Sun City, Arizona, United States; Little Rock, Arkansas, United States and 85 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.