A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting

Launched by TAKEDA · Aug 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Vedolizumab to see how effective it is for adults with Ulcerative Colitis (UC) or Crohn's Disease (CD), which are long-term conditions affecting the gut. The main goal is to find out how many participants experience a reduction in their symptoms, like diarrhea and belly pain, after 14 weeks of treatment. Participants will receive Vedolizumab through an intravenous infusion for the first 6 weeks, followed by injections under the skin for about a year. If the treatment isn't working well by the 14-week mark, participants will stop taking Vedolizumab and can switch to another treatment.

To join the study, participants need to be between 18 and 80 years old and have a diagnosis of moderate to severe UC or CD. They should also have not responded well to other treatments in the past. Throughout the trial, participants will have regular visits to the study clinic, where their progress will be closely monitored. It’s important for those interested to know that they will need to follow specific guidelines regarding contraception if they are women of childbearing potential or fertile men, as well as comply with other health requirements.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• To be eligible to participate in this study, participants must meet all the following criteria:
• • 1. In the investigator's opinion, the participant can understand and comply with protocol requirements.
• • 2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.
• • 3. The participant is 18 to 80 years of age at the time of signing the ICF.
• • 4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).
• 5. If participant is a woman of childbearing potential (WOCBP):
• • 1. 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.
• • 2. 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.
• • 3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.
• • 4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.
• 6. If participant is a fertile man:
• • 1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab
• • 2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.
• 7. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:
• • 1. 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
• • 2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening
• • 8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.
• • 9. 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.
• • Exclusion Criteria
• Participants who meet any of the following exclusion criteria will be excluded from participation in this study:
• • 1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\]) at any time prior to screening.
• • 2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.
• • 3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).
• • 4. 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 allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \[FDA\] 2024).
• • 5. Received any investigational biologic therapy \<= 6 months prior to screening.
• • 6. 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 (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).
• • 7. The participant has any evidence of an active infection during screening.
• • 8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.
• • 9. 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.
• • 10. 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 screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.
• • 11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.
• • 12. Has laboratory abnormalities during the screening period.