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A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
NCT06045754 · View on ClinicalTrials.gov ↗
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 |
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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. 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 100 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 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions — of which Ustekinumab 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: NCT06045754 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Illinois. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06045754?
The interventions under investigation include: Ustekinumab (DRUG), Adalimumab (DRUG), Vedolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06045754?
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 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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