NCT06581328ClinicalTrials.gov

A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting

A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting

RecruitingTaking participants now, according to the registry record.

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In brief

Phase 4200 participants sought101 sites1 country

Registered in 1 registry

ClinicalTrials.govNCT06581328Open this record at ClinicalTrials.govSynced 5 days ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-09-03; recorded start 2025-03-27
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 194 other studies in this databaseCounted from the lead sponsor named in the record (Takeda)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 4 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Non-randomised allocation
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 101 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 200 participants (target), run at 101 sites.

How this score is built

Enrolment25/40
400 participants (target)
Site count23/25
101 sites
Country count0/15
Single country
Planned duration8/10
Planned over about 39 months
Sponsor scale9/10
Takeda has led 192 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission). Participants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab. During the study, participants will visit their study clinic several times.

Conditions

Ulcerative Colitis
Crohn's Disease

Eligibility

Eligibility
Sex	All
Ages	18 Years – 80 Years
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria To be eligible to participate in this study, participants must meet all the following criteria: 1. In the investigator's opinion, the participant can understand and comply with protocol requirements. 2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures. 3. The participant is 18 to 80 years of age at the time of signing the ICF. 4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI). 5. Participants must meet the contraception recommendations. 6. The participant has a diagnosis of moderate to severely active UC or CD defined by the following: 1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \>=6 (\>=4 if isolated ileal disease) at screening OR 2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy sub-score of 2 to 3 at screening. 7. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report. 8. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy. Exclusion Criteria Participants who meet any of the following exclusion criteria will be excluded from participation in this study: 1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\]) at any time prior to screening. 2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments. 3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD). 4. In the investigator's opinion, the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients. 5. Received any investigational biologic therapy \<= 6 months prior to screening. 6. The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening. a. Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators. 7. The participant has any evidence of an active infection during screening. 8. Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome. 9. A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period. 10. History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening; and adequately treated cervical carcinoma in situ that has not recurred for at least 3 years before screening. Participants with a remote history of malignancy (e.g., \>10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and therapy received; this must be discussed with the sponsor on a case-by-case basis before enrollment. 11. Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorders that, in the investigator's opinion, would confound the study results or compromise participant safety. 12. Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease. 13. Participant is not on a stable dose of corticosteroid. 14. Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin \<8 grams per deciliter (g/dL); (b) white blood cell (WBC) count \<3.0 × 10\^9 per liter (L); (c) lymphocyte count \<0.5 × 10\^9/L; (d) platelet count \<100 × 10\^9/L or \>1200 × 10\^9/L; (e) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3.0 × the upper limit of normal (ULN); or (f) alkaline phosphatase (ALP) \>1.5 × ULN. Historical laboratory data may be used for screening if available in the participant's electronic health record (EHR) within 6 weeks before screening.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 4
Allocation	Non-randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	200 participants sought

Sponsor and collaborators

Takeda Sponsor

Arms and interventions

UC Participants: VedolizumabEXPERIMENTAL
Participants with moderate to severely active UC will receive vedolizumab 300 milligrams (mg), intravenous (IV) infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg subcutaneous (SC) injection at Week 6, to be administered every 2 weeks until Week 50. Treating health care practitioner (HCP) may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.
CD Participants: VedolizumabEXPERIMENTAL
Participants with moderate to severely active CD will receive vedolizumab 300 mg, IV infusion at Weeks 0 and 2. Following the first 2 vedolizumab IV doses, participant may be switched to vedolizumab 108 mg SC injection at Week 6, to be administered every 2 weeks until Week 50. Treating HCP may give an additional dose of vedolizumab IV at Week 6 with mandatory transition by Week 14.

Interventions

Drug Vedolizumab IV
Vedolizumab IV infusion
Drug Vedolizumab SC
Vedolizumab SC injection

Outcome measures

Primary outcome
Percentage of CD Participants With 2-item Patient-reported Outcome Measure (PRO-2) Remission at Week 14
PRO-2 remission is defined as 7-day average of very soft or liquid stool frequency (SF) less than and equal to (\<=) 2.8, 7-day average of abdominal pain (AP) score \<= 1.0, and neither worse than baseline.
Time frame At Week 14
Primary outcome
Percentage of UC Participants With PRO-2 Remission at Week 14
PRO-2 remission is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
Time frame At Week 14
Secondary outcome
Percentage of CD and UC Participants With PRO-2 Remission at Weeks 6 and 52
PRO-2 remission for CD participants is defined as 7-day average of very soft or liquid SF \<= 2.8, 7-day average of AP score \<= 1.0, and neither worse than baseline. PRO-2 remission for UC participants is defined as Mayo rectal bleeding sub-score of 0 and stool frequency sub-score \<=1.
Time frame At Weeks 6 and 52
Secondary outcome
Percentage of CD and UC Participants With Clinical Response at Weeks 6, 14, and 52
CD clinical response is defined as greater than and equal to (\>=) 100 points decrease from baseline in CDAI score. UC clinical response is defined as reduction in complete Mayo score of \>=3 points and \>=30 percent (%) from baseline with an accompanying decrease in rectal bleeding sub-score of \>=1 point or absolute rectal bleeding sub-score of \<=1 point or an absolute rectal bleeding sub-score of \<=1 point, or a reduction in partial Mayo score of \>=2 points and \>=25% from baseline, if complete Mayo score was not performed at visit.
Time frame At Weeks 6, 14, and 52
Secondary outcome
Percentage of CD Participants With Endoscopic Response at Week 52
Endoscopic response is defined as a \>=50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing.
Time frame At Week 52
Secondary outcome
Percentage of CD Participants Achieving Endoscopic Remission at Week 52
Endoscopic remission as per SES-CD is defined as a SES-CD score of 0 to 4, with no individual sub-score greater than 1. SES-CD evaluates 4 endoscopic variables: the intestinal surface affected by ulcers, the intestinal surface affected by other inflammatory lesions, the presence of ulcers, and the presence of narrowing.
Time frame At Week 52
Secondary outcome
Percentage of UC Participants With Improvement of Endoscopic Appearance of the Mucosa at Week 52
Improvement of endoscopic appearance of the mucosa is defined as Modified Mayo endoscopic sub-score (MMES) of 0 or 1.
Time frame At Week 52
Secondary outcome
Percentage of UC Participants With Endoscopic Remission at Week 52
Endoscopic remission is defined as a centrally read complete Mayo endoscopy sub-score of 0.
Time frame At Week 52
Secondary outcome
Percentage of CD and UC Participants With Clinical Remission at Weeks 6, 14, and 52
Clinical Remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score greater than (\>) 1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, physician's global assessment \[PGA\]) score of \<=2 and no individual sub-score \>1.
Time frame At Weeks 6, 14, and 52
Secondary outcome
Percentage of CD and UC Participants With Clinical Remission at Week 52
Clinical remission for CD is defined as a CDAI \<150 point. Clinical remission for UC is defined as complete MS of \<=2 points and no participant sub-score \>1 point or defined as a partial Mayo score (stool frequency, rectal bleeding, PGA) score of \<=2 and no individual sub-score \>1. Percentage of CD and UC participants with clinical remission at Week 52, among those participants who achieved clinical remission at Week 6 and 14 will be reported.
Time frame At Week 52
Secondary outcome
Change From Baseline in C-reactive Protein (CRP) levels of CD and UC Participants at Weeks 6, 14, 26, and 52
Change from baseline in CRP levels of CD and UC participants at Weeks 6, 14, 26, and 52 will be reported.
Time frame Baseline, Weeks 6, 14, 26, and 52
Secondary outcome
Change From Baseline in Fecal Calprotectin Concentrations of CD and UC participants at Weeks 6, 14, and 52
Change from baseline in fecal calprotectin concentrations of CD and UC participants at Weeks 6, 14, and 52 will be reported.
Time frame Baseline, Weeks 6, 14, and 52
Secondary outcome
Percentage of CD and UC Participants With Serious Infections
Percentage of CD and UC participants with serious infections will be reported.
Time frame Up to end of study (up to 72 weeks)

Dates

Dates
Start date	March 27, 2025 (actual)
Primary completion	May 1, 2027 (estimated)
Completion	June 1, 2028 (estimated)
First posted	September 3, 2024 (actual)
Last updated	September 15, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

78 sites are recruiting

United States

United States
Facility	City	State or region	Status
Presbyterian Health care services	Albuquerque	New Mexico	Withdrawn
Digestive Healthcare of Georgia	Atlanta	Georgia	Recruiting
AGA GA Research LLC	Atlanta	Georgia	Recruiting
Baton Rouge General Medical Center - Bluebonnet Campus	Baton Rouge	Louisiana	Recruiting
GI Alliance	Bellevue	Washington	Recruiting
Gastro Health	Birmingham	Alabama	Recruiting
SSM Health Medical Group	Bridgeton	Missouri	Recruiting
Access Research Institute	Brooksville	Florida	Recruiting
Westchester Putnam Gastroenterology PC	Carmel	New York	Recruiting
Five Towns Gastroenterology	Cedarhurst	New York	Recruiting
AZ Gastro Care	Chandler	Arizona	Recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C	Charlotte	North Carolina	Recruiting
Capital Digestive Care	Chevy Chase	Maryland	Recruiting
Gastro Health Research - Cincinnati	Cincinnati	Ohio	Recruiting
Gastro Florida	Clearwater	Florida	Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	Recruiting
GI Associates Research, LLC	Columbia	Missouri	Recruiting
Tri-State Gastroenterology Associates	Crestview Hills	Kentucky	Recruiting
DSI Research Northridge LLC	Dayton	Ohio	Recruiting
Atlanta Center for Gastroenterology, P.C.	Decatur	Georgia	Withdrawn
Yapp, Rockford M.D. (Private Practice)	Downers Grove	Illinois	Recruiting
The Clinical Trials Network CTNX LLC	El Paso	Texas	Recruiting
IMIDeology	Elmhurst	New York	Recruiting
Gastroenterology and Liver Institute	Escondido	California	Recruiting
Gastro Health Research - Framingham	Framingham	Massachusetts	Recruiting
Intercity Gastroenterology	Fresh Meadows	New York	Recruiting
Amel Med LLC	Georgetown	Texas	Recruiting
Spectrum Research Institute LLC	Gilbert	Arizona	Recruiting
Woodholme Gastroenterology	Glen Burnie	Maryland	Recruiting
GI Alliance - Glenview	Glenview	Illinois	Recruiting
Carolina Digestive Diseases	Greenville	North Carolina	Recruiting
Doral Medical Research, LLC	Hialeah	Florida	Withdrawn
Integrity Advanced Therapeutics	Houston	Texas	Withdrawn
Kelsey Research Foundation	Houston	Texas	Recruiting
MedCare Pharma LLC	Houston	Texas	Recruiting
Spring Clinical Research	Houston	Texas	Recruiting
Hutchinson Clinic	Hutchinson	Kansas	Recruiting
Mid America Gastro Intestinal Consultants	Kansas City	Missouri	Recruiting
Gastro Health & Nutrition	Katy	Texas	Recruiting
Tri-Cities Gastroenterology	Kingsport	Tennessee	Recruiting
One of a Kind Clinical Research Center LLC	Kingwood	Texas	Recruiting
Digestive and Liver Center of Florida, P.A.	Kissimmee	Florida	Recruiting
Combined Gastro LLC	Lafayette	Louisiana	Recruiting
Gastroenterology and Internal Medicine Specialists, SC	Lake Barrington	Illinois	Recruiting
NYU Langone Long Island Clinical Research Associates	Lake Success	New York	Withdrawn
Gastro Health Research - Liberty Township	Liberty Township	Ohio	Recruiting
UAMS Health Gastroenterology Clinic	Little Rock	Arkansas	Withdrawn
Rocky Mountain Endocopy Centers LLC	Littleton	Colorado	Recruiting
West Texas Research Institute	Lubbock	Texas	Recruiting
Great Lakes Gastroenterology Research, LLC	Mentor	Ohio	Recruiting

51 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 15, 2026
Completion date moved earlier
Primary completion advanced 153 days
2027-10-012027-05-01
September 15, 2026
Enrolment target changed
Enrollment target revised down from 400 to 200
400200

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06581328

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

United States

Study documents

Changes over time