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NCT06095128 · ClinicalTrials.gov registry record · Phase 4
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
A Phase 4 study of Ulcerative Colitis, sponsored by Takeda.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT06095128: Recruiting Phase 4 study of Ulcerative Colitis, sponsored by Takeda.
NCT06095128 is a Phase 4 study of Ulcerative Colitis that is actively recruiting participants, run by Takeda. The registered enrollment target is 65 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06095128, a Phase 4 study of Ulcerative Colitis, is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 65 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 tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks. Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.
Primary Outcome
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore \>1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more
Conditions Studied
Interventions
- DRUG Vedolizumab
- DRUG Tofacitinib
Study Locations (20)
Illinois
- University of Chicago Medicine - Chicago
- GI Alliance - Illinois Gastroenterology Group - Glenview - Glenview
- GI Alliance - Illinois Gastroenterology Group LLC - Gurnee - Gurnee
Missouri
- Mid-America Gastro-Intestinal Consultants - Kansas City
- BVL Clinical Research - Liberty
- Washington University School of Medicine - St Louis
California
- Cedars-Sinai Medical Center - Los Angeles
- Hoag Hospital Newport Beach - Newport Beach
Florida
- Endoscopic Research Inc - Orlando
- Alliance Clinical Research of Tampa, LLC - Tampa
Louisiana
- GI Alliance - Metairie
- Tulane University - New Orleans
Alabama
- Digestive Health Specialsits - Dothan
Arizona
- GI Alliance Sun City - Sun City
Georgia
- Gastroenterology Consultants, P.C. - Roswell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2024-06-12 |
| Est. Completion | 2027-07-09 |
| Phase | Phase 4 |
What NCT06095128 shows while recruiting
NCT06095128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Vedolizumab is the first listed.
NCT06095128 names 20 study sites across 13 states, led by Illinois, Missouri, California.
Frequently Asked Questions
What is clinical trial NCT06095128 about?
NCT06095128 is a clinical study titled "A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)". The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment. All participants wi...
What is the current status of trial NCT06095128?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2024-06-12. Estimated completion is 2027-07-09.
What conditions does trial NCT06095128 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06095128?
The interventions under investigation include: Vedolizumab (DRUG), Tofacitinib (DRUG).
Who is sponsoring clinical trial NCT06095128?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06095128 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06095128's enrollment target sits among peer trials
65 78th of 122 higher than 45 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.
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