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

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Kurz gefasst

Phase 4200 Teilnehmende gesucht101 Studienzentren1 Land

Kategorien

Gastroenterologie und Hepatologie96%Dermatologie4%

In 1 Register registriert

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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.

Zusammenfassung

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.

Erkrankungen

Ulcerative Colitis
Crohn's Disease

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – 80 Years
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 4
Zuteilung	Nicht randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	NONE (0)
Teilnahme	200 Teilnehmende gesucht

Sponsor und Mitwirkende

Takeda Sponsor

Studienarme und Interventionen

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.

Interventionen

Arzneimittel Vedolizumab IV
Vedolizumab IV infusion
Arzneimittel Vedolizumab SC
Vedolizumab SC injection

Endpunkte

Primärer Endpunkt
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.
Zeitrahmen At Week 14
Primärer Endpunkt
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.
Zeitrahmen At Week 14
Sekundärer Endpunkt
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.
Zeitrahmen At Weeks 6 and 52
Sekundärer Endpunkt
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.
Zeitrahmen At Weeks 6, 14, and 52
Sekundärer Endpunkt
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.
Zeitrahmen At Week 52
Sekundärer Endpunkt
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.
Zeitrahmen At Week 52
Sekundärer Endpunkt
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.
Zeitrahmen At Week 52
Sekundärer Endpunkt
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.
Zeitrahmen At Week 52
Sekundärer Endpunkt
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.
Zeitrahmen At Weeks 6, 14, and 52
Sekundärer Endpunkt
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.
Zeitrahmen At Week 52
Sekundärer Endpunkt
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.
Zeitrahmen Baseline, Weeks 6, 14, 26, and 52
Sekundärer Endpunkt
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.
Zeitrahmen Baseline, Weeks 6, 14, and 52
Sekundärer Endpunkt
Percentage of CD and UC Participants With Serious Infections
Percentage of CD and UC participants with serious infections will be reported.
Zeitrahmen Up to end of study (up to 72 weeks)

Daten

Daten
Startdatum	27. März 2025 (tatsächlich)
Primärer Abschluss	1. Mai 2027 (geschätzt)
Abschluss	1. Juni 2028 (geschätzt)
Erstveröffentlichung	3. September 2024 (tatsächlich)
Zuletzt aktualisiert	15. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

78 Studienzentren rekrutieren

United States

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

51 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

15. September 2026
Abschlussdatum nach vorne verschoben
Primary completion advanced 153 days
2027-10-012027-05-01
15. September 2026
Teilnahmeziel geändert
Enrollment target revised down from 400 to 200
400200

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