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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: Recruiting Phase 4 study of Crohn's Disease, sponsored by Takeda.
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 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Endoscopic response is defined by a \>=50 percent (%) reduction from baseline in the SES-CD. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for pre
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 |
What NCT06045754 shows while recruiting
NCT06045754 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
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 NCT06045754's enrollment target sits among peer trials
100 70th of 105 higher than 36 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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.
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