Ulcerative Colitis study: Vedolizumab IV vs Vedolizumab SC
Official title A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
ClinicalTrials.gov ID: NCT06581328
What this study is testing
What is Vedolizumab IV?
This is an investigational medicine being studied to treat ulcerative colitis. It is designed to block specific proteins in the gut to help reduce swelling and inflammation.
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
- This study is testing whether Vedolizumab can reduce symptoms of ulcerative colitis and Crohn's disease after 14 weeks of treatment.
- Who it's for
- You may be able to join if you are an adult with ulcerative colitis or Crohn's disease and can travel to a clinic for visits.
- What's involved
- You will receive Vedolizumab first by a vein infusion for 6 weeks, then by a skin injection for the rest of the year. You will have clinic visits to monitor your health and to get the injections.
- Time commitment
- The study lasts about 52 weeks, with visits at 6 weeks, 14 weeks, 26 weeks, 52 weeks, and a follow‑up 18 weeks after the last injection.
- 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
- 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).
- Participants must meet the contraception recommendations.
You likely can't join if
- 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.
- The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening. a.
See the full eligibility 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).
- Participants must meet the contraception recommendations.
- 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 sub-score 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.
- 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 a 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 within 60 days prior to screening. a.
- 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 30 days prior to screening or planned or possible major surgery during the study period.
- History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening
- Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary...
- Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis...
- Participant is not on a stable dose of corticosteroid.
- Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin \ 1200 × 10\^9/L
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Sun City, Arizona, United States
- Escondido, California, United States
- Murrieta, California, United States
- Colorado Springs, Colorado, United States
- Littleton, Colorado, United States
- Brooksville, Florida, United States
- Clearwater, Florida, United States
- Kissimmee, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Pinellas Park, Florida, United States
- Atlanta, Georgia, United States
- Downers Grove, Illinois, United States
- Glenview, Illinois, United States
- Lake Barrington, Illinois, United States
+ 54 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; Mobile, Alabama, United States; Chandler, Arizona, United States; Gilbert, Arizona, United States; Sun City, Arizona, United States; Escondido, California, United States and 68 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.