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A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
NCT06581328 · View on ClinicalTrials.gov ↗
Study Summary
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), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.
Conditions Studied
Interventions
- DRUG Vedolizumab IV
- DRUG Vedolizumab SC
Study Locations (20)
California
- Gastroenterology and Liver Institute — Escondido
- Inland Empire Gastroenterology — Murrieta
- United Clinical Research Institute — Murrieta
- Digestive Health Institute — Newport Beach
- Knowledge Research Center — Orange
- Medical Associates Research Group, Inc. — San Diego
Florida
- Access Research Institute — Brooksville
- Gastro Florida — Clearwater
- Doral Medical Research, LLC — Hialeah
- Digestive and Liver Center of Florida, P.A. — Kissimmee
- Gastro Health Research - Miami — Miami
Arizona
- AZ Gastro Care — Chandler
- Spectrum Research Institute LLC — Gilbert
- GI Alliance- Sun City — Sun City
Colorado
- Peak Gastroenterology Associates — Colorado Springs
- Associates in Gastroenterology, PC — Colorado Springs
- Rocky Mountain Endocopy Centers LLC — Littleton
Alabama
- Gastro Health Research- St. Vincents East — Birmingham
- East View Medical Research — Mobile
Arkansas
- UAMS Health Gastroenterology Clinic — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-03-27 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06581328
The ClinicalTrials.gov registry entry for NCT06581328 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Vedolizumab IV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06581328 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06581328 about?
NCT06581328 is a clinical study titled "A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting". 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...
What is the current status of trial NCT06581328?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2025-03-27. Estimated completion is 2028-06-01.
What conditions does trial NCT06581328 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Crohn's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06581328?
The interventions under investigation include: Vedolizumab IV (DRUG), Vedolizumab SC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06581328?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06581328 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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