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NCT06581328 · ClinicalTrials.gov registry record · Phase 4
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
A Phase 4 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT06581328 is a Phase 4 study of Ulcerative Colitis and Crohn's Disease that is actively recruiting participants, run by Takeda. The registered enrollment target is 400 participants, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT06581328, a Phase 4 study of Ulcerative Colitis and Crohn's Disease, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (81% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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.
NCT06581328 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arizona.
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.
What interventions are being tested in trial NCT06581328?
The interventions under investigation include: Vedolizumab IV (DRUG), Vedolizumab SC (DRUG).
Who is sponsoring clinical trial NCT06581328?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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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