A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease (NCT06227910) — UK Trial Details

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

VedolizumabUpadacitinibPlacebo

Vedolizumab: Vedolizumab IV infusion.

Upadacitinib: Upadacitinib over-encapsulated tablets.

Placebo: Upadacitinib matched placebo capsules.

Study summary

The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants.

All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks.

During the study, participants will visit their study clinic 15 times.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

No

Inclusion Criteria: 1. The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report. 2. The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450. 3. The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score of \>=6 (or \>=4 for participants with isolated ileal disease), as confirmed by a central reader. 4. The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy. Exclusion Criteria: 1. The participant has a current diagnosis of ulcerative colitis or indeterminate colitis. 2. The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or oral/intramuscular anti-infectives within 14 days prior to baseline. 3. The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to screening, or ongoing chronic infection. 4. The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex. 5. The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study. 6. The participant has an ostomy or ileoanal pouch. 7. The participant has severe renal impairment, defined as an estimated glomerular filtration rate of \<30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2). 8. The participant has severe (Child-Pugh C) hepatic impairment.

Primary outcome measure(s)

Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 — Week 12
Clinical remission is defined as a CDAI score of less than (\<) 150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12 — Week 12
Endoscopic response per SES-CD is defined as decrease in SES CD greater than (\>) 50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or a \>=2-point reduction in SES-CD from baseline) read centrally. SES-CD evaluates 4 endoscopic variables (ulcer size,percentage of ulcerated and affected surface area, presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum,right,transverse,and left colon,rectum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. Overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.

Trial sites (138)

Facility	City	Region	Status
UCSD Medical Center	La Jolla	California	Not Yet Recruiting
Keck Medicine Of USC - USC Healthcare Center 1	Los Angeles	California	Not Yet Recruiting
Peak Gastroenterology Associates	Colorado Springs	Colorado	Recruiting
GI PROS, Inc.	Naples	Florida	Active Not Recruiting
Orlando Health Ambulatory Care Center	Orlando	Florida	Active Not Recruiting
USF Health Morsani Center for Advanced Healthcare	Tampa	Florida	Active Not Recruiting
Indiana University (IU) Health University Hospital	Indianapolis	Indiana	Active Not Recruiting
University of Kentucky	Lexington	Kentucky	Active Not Recruiting
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center	New York	New York	Active Not Recruiting
Columbia University Medical Center, New York-Presbyterian Hospital	New York	New York	Not Yet Recruiting
Lenox Hill Hospital Northwell Health	New York	New York	Active Not Recruiting
Gastroenterology Associates	Greenville	South Carolina	Active Not Recruiting
Rapid City Medical Center	Rapid City	South Dakota	Active Not Recruiting
Southern Star Research Institute, LLC	San Antonio	Texas	Recruiting
Tyler Research Institute, LLC	Tyler	Texas	Recruiting
Virginia Mason Medical Center	Seattle	Washington	Active Not Recruiting
Swedish Cancer Institute	Seattle	Washington	Not Yet Recruiting
University of Washington Medical Center - Montlake	Seattle	Washington	Not Yet Recruiting
Medical College of Wisconsin Cancer Center - Froedtert Hospital	Milwaukee	Wisconsin	Not Yet Recruiting
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III	Vienna	State of Vienna	Not Yet Recruiting
Medical University Innsbruck	Innsbruck	Tyrol	Not Yet Recruiting
Johannes Kepler Universitat Linz (JKU)	Linz	Austria	Not Yet Recruiting
Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss	Salzburg	Austria	Not Yet Recruiting
Krankenhaus der Barmherzigen Brueder Wien	Vienna	Austria	Not Yet Recruiting
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel	Brussels	Anderlecht	Not Yet Recruiting
Imelda GI Clinical Research Center	Bonheiden	Belgium	Active Not Recruiting
Universitair Ziekenhuis Gent	Ghent	Belgium	Not Yet Recruiting
University Hospitals Leuven	Leuven	Belgium	Not Yet Recruiting
Centre Hospitalier Chretien MontLegia	Liège	Belgium	Not Yet Recruiting
Hospital Universitario Cajuru	Curitiba	Paraná	Not Yet Recruiting
Faculdade de Medicina de Botucatu	Botucatu	São Paulo	Not Yet Recruiting
Centro de Estudos Clinico do Interior Paulista - CECIP	Jaú	São Paulo	Not Yet Recruiting
Pesquisare Saude	Santo André	São Paulo	Not Yet Recruiting
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)	Rio de Janeiro	Brazil	Not Yet Recruiting
Hospital das Clinicas of the University of Sao Paulo (Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC/FMUSP))	São Paulo	Brazil	Not Yet Recruiting
Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo	São Paulo	Brazil	Not Yet Recruiting
Heritage Medical Research Clinic - University Of Calgary	Calgary	Alberta	Active Not Recruiting
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre	Winnipeg	Manitoba	Not Yet Recruiting
Dalhousie University	Halifax	Nova Scotia	Not Yet Recruiting
Barrie GI Associates	Barrie	Ontario	Recruiting

+ 98 more sites — see the full list on the official registry below.

On this site

📄 Entyvio (vedolizumab) drug profile → 📄 Rinvoq (upadacitinib) drug profile →

More Takeda trials in the UK

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions Recruiting

A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer Active, not recruiting

A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura Active, not recruiting

Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis) Recruiting

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy Recruiting

Other trials for the same condition

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease Recruiting

Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Recruiting

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease Active, not recruiting