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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06095128
The ClinicalTrials.gov registry entry for NCT06095128 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Related
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