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NCT06045754 · ClinicalTrials.gov registry record · Phase 4
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
A Phase 4 study of Crohn's Disease, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT06045754 is a Phase 4 study of Crohn's Disease that is actively recruiting participants, run by Takeda. The registered enrollment target is 100 participants, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT06045754, a Phase 4 study of Crohn's Disease, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.
Conditions Studied
Interventions
- DRUG Ustekinumab
- DRUG Adalimumab
- DRUG Vedolizumab
Study Locations (20)
Florida
- Clinical Research of Osceola - Kissimmee
- Endoscopic Research Inc - Orlando
- University of South Florida - Tampa
- Alliance Clinical Research of Tampa, LLC - Tampa
California
- University of California San Diego Health (UCSD) - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
- Hoag Hospital Newport Beach - Newport Beach
Illinois
- University of Chicago Medicine - Chicago
- GI Alliance - Illinois Gastroenterology Group - Glenview - Glenview
- GI Alliance - Illinois Gastroenterology Group LLC - Gurnee - Gurnee
Kansas
- University of Kansas Medical Center - Kansas City
- Cotton ONeil Clinical Research Center - Topeka
Louisiana
- GI Alliance - Metairie
- Tulane University - New Orleans
Alabama
- Digestive Health Specialsits - Dothan
Arizona
- GI Alliance Sun City - Sun City
Connecticut
- Medical Research Center of Connecticut, LLC - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2027-06-28 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06045754
The ClinicalTrials.gov registry entry for NCT06045754 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,414-participant average among 104 other Crohn's Disease trials with a reported enrollment target (96% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions - of which Ustekinumab is the first listed.
NCT06045754 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06045754 about?
NCT06045754 is a clinical study titled "A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease". The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual t...
What is the current status of trial NCT06045754?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2024-04-18. Estimated completion is 2027-06-28.
What conditions does trial NCT06045754 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT06045754?
The interventions under investigation include: Ustekinumab (DRUG), Adalimumab (DRUG), Vedolizumab (DRUG).
Who is sponsoring clinical trial NCT06045754?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06045754 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.