Not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.
PSC Trial Watch
Crohn'sRecruiting

A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Phase 4 · Testing Vedolizumab, Adalimumab and Ustekinumab · 48 sites · Takeda

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Vedolizumab (a drug), Adalimumab (a drug), Ustekinumab (a drug) and Ustekinumab (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.

It is open-label: participants know what they are receiving.

Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.

Who can join

Some of the main requirements, copied from the record:

Plus 7 more requirement(s). There are also 18 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhasePhase 4
Study typeInterventional
ConditionsCrohn's Disease
Lead sponsorTakeda
Enrollment50 (estimated)
Start date2024-04-18
Primary completion (est.)2027-06-28
First posted2023-09-21
Last updated2026-09-09
Official titleAn Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)
ClinicalTrials.gov IDNCT06045754

Interventions

Full eligibility criteria (from the record)
Inclusion Criteria:

Part A:

1. Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.
2. Has moderately to severely active CD at Screening, defined as an SES-CD >=6 (>=4 if isolated ileal disease).
3. Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:

   1. Inadequate response after completing the full induction regimen;
   2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
   3. Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).

   Note: Participants with an inadequate response to >2 classes of advanced therapies or >1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.

   Part B:
4. In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.

Exclusion Criteria:

1. CDAI score > 450.
2. A current diagnosis of ulcerative colitis or indeterminate colitis.
3. Clinical evidence of an abdominal abscess.
4. Known fistula (other than perianal fistula) or phlegmon.
5. Known perianal fistula with abscess.
6. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.
7. Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
8. Short bowel syndrome.
9. Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.
10. History or evidence of adenomatous colonic polyps that have not been removed.
11. History or evidence of colonic mucosal dysplasia.
12. Intolerance or contraindication to ileocolonoscopy.
13. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).
14. Active or latent tuberculosis (TB), regardless of treatment history.
15. A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.
16. A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).
17. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \[AMG 181\], anti- mucosal addressin cell adhesion molecule-1 \[MAdCAM-1\] antibodies, or rituximab) for the treatment of CD.
18. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee. If the PML IAC deems the participant to have PML, the participant is ineligible.

Locations (48)

Show all 48 sites
SiteCityCountrySite status
Digestive Health SpecialsitsDothan, AlabamaUnited StatesRecruiting
GI Alliance Sun CitySun City, ArizonaUnited StatesRecruiting
University of California San Diego Health (UCSD)La Jolla, CaliforniaUnited StatesRecruiting
Cedars-Sinai Medical CenterLos Angeles, CaliforniaUnited StatesRecruiting
Hoag Hospital Newport BeachNewport Beach, CaliforniaUnited StatesRecruiting
Medical Research Center of Connecticut, LLCHamden, ConnecticutUnited StatesRecruiting
Clinical Research of OsceolaKissimmee, FloridaUnited StatesRecruiting
Endoscopic Research IncOrlando, FloridaUnited StatesRecruiting
Alliance Clinical Research of Tampa, LLCTampa, FloridaUnited StatesRecruiting
Gastroenterology Consultants, P.C.Roswell, GeorgiaUnited StatesRecruiting
University of Chicago MedicineChicago, IllinoisUnited StatesRecruiting
University of Kansas Medical CenterKansas City, KansasUnited StatesRecruiting
Cotton ONeil Clinical Research CenterTopeka, KansasUnited StatesRecruiting
University of LouisvilleLouisville, KentuckyUnited StatesRecruiting
GI AllianceMetairie, LouisianaUnited StatesRecruiting
Tulane UniversityNew Orleans, LouisianaUnited StatesRecruiting
Huron Gastroenterology Associates, P.C.Ypsilanti, MichiganUnited StatesRecruiting
Mid-America Gastro-Intestinal ConsultantsKansas City, MissouriUnited StatesRecruiting
BVL Clinical ResearchLiberty, MissouriUnited StatesRecruiting
Washington University School of MedicineSt Louis, MissouriUnited StatesRecruiting
NYU Langone HealthNew York, New YorkUnited StatesRecruiting
University of CincinnatiCincinnati, OhioUnited StatesRecruiting
Ohio Gastroenterology group, Inc.Columbus, OhioUnited StatesRecruiting
Great Lakes Gastroenterology Research, LLCMentor, OhioUnited StatesRecruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC.Westlake, OhioUnited StatesRecruiting
Digestive Disease Specialists, Inc.Oklahoma City, OklahomaUnited StatesRecruiting
Allegheny Health NetworkWexford, PennsylvaniaUnited StatesRecruiting
University GastroenterologyProvidence, Rhode IslandUnited StatesRecruiting
Sanford Health ResearchRapid City, South DakotaUnited StatesRecruiting
Texas Digestive Disease Consultants Cedar ParkCedar Park, TexasUnited StatesRecruiting
GI Alliance - Digestive Health Associates of TexasDallas, TexasUnited StatesRecruiting
The University of Texas Health Science Center at HoustonHouston, TexasUnited StatesRecruiting
Texas Digestive Disease Consultants LubbockLubbock, TexasUnited StatesRecruiting
GI Alliance - MansfieldMansfield, TexasUnited StatesRecruiting
Gastroenterology Research of San Antonio, LLCSan Antonio, TexasUnited StatesRecruiting
Southern Star Research Institute, LLC.San Antonio, TexasUnited StatesRecruiting
Texas Digestive Disease Consultants (TDDC), SouthlakeSouthlake, TexasUnited StatesRecruiting
Tyler Research Institute, LLCTyler, TexasUnited StatesRecruiting
GI Alliance - WebsterWebster, TexasUnited StatesRecruiting
University of Utah HealthSalt Lake City, UtahUnited StatesRecruiting
Washington Gastroenterology- GIATacoma, WashingtonUnited StatesRecruiting
Covenant HealthEdmonton, AlbertaCanadaRecruiting
London Health Sciences CentreLondon, OntarioCanadaRecruiting
Viable Clinical Research - North BayNorth Bay, OntarioCanadaRecruiting
Toronto Immune and Digestive Health Institute Inc. (TIDHI)North York, OntarioCanadaRecruiting
ABP Research Services Corp.Oakville, OntarioCanadaRecruiting
Toronto Digestive Disease Associates (TDDA) Inc.Vaughan, OntarioCanadaRecruiting
The Research Institute of the McGill University Health CentreMontreal, QuebecCanadaRecruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.