Is NCT06581328 recruiting in Birmingham, AL?

Yes, NCT06581328 is currently recruiting participants at its Birmingham, AL location. This inflammatory bowel disease clinical trial is actively enrolling qualified participants.

How do I join the inflammatory bowel disease clinical trial in Birmingham?

To join this clinical trial in Birmingham, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Birmingham clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Inflammatory Bowel Disease Clinical Trial in Birmingham, AL

About This Inflammatory Bowel Disease Study in Birmingham

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). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), partici

Sponsor: Takeda

Who Can Participate

Inclusion 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.

Exclusion Criteria

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 allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \[FDA\] 2024).

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 (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).

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 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.

History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.

Has laboratory abnormalities during the screening period.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Birmingham?

Yes, this clinical trial (NCT06581328) has an active research site in Birmingham, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Inflammatory Bowel Disease Treatment Options in Birmingham, AL

If you're searching for inflammatory bowel disease treatment options in Birmingham, AL, this clinical trial (NCT06581328) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Birmingham research site is actively enrolling participants for this phase 4 clinical trial. You'll receive care from experienced inflammatory bowel disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all inflammatory bowel disease clinical trials near you to find additional studies recruiting in your area.

Inflammatory Bowel Disease Clinical Trial in Birmingham, AL

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