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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: Recruiting Phase 4 study of Ulcerative Colitis and Crohn's Disease, sponsored by Takeda.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.

Conditions Studied

Ulcerative Colitis Crohn's Disease

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

FieldValue
Enrollment Target 400 participants
Start Date 2025-03-27
Est. Completion 2028-06-01
Phase Phase 4
Takeda

408 total trials

What NCT06581328 shows while recruiting

NCT06581328 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 2,054-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (81% lower).

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 names 20 study sites across 6 states, led by 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.

Learn More About Clinical Trials

Similar trials for Ulcerative Colitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06581328's enrollment target sits among peer trials

400 26th of 122 higher than 97 of 122 other Ulcerative Colitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06581328

Source: ClinicalTrials.gov NCT06581328, the US trial registry maintained by the National Library of Medicine. NCT06581328 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.