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Recruiting

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

ClinicalTrials.gov ID NCT06095128
Sponsor Takeda
Information provided by Takeda (Responsible Party)
Last Update Posted 2024-11-15
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Study Overview

Brief 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.

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Detailed Description

The drugs being tested in this study are called Vedolizumab and Tofacitinib. Vedolizumab and Tofacitinib dual targeted therapy is being tested to treat people with moderate to severe ulcerative colitis (UC) who have experienced inadequate response, loss of response or intolerance to no more than 2 prior tumor necrosis factor (TNF) antagonists. This study will look at the clinical remission in people who take Vedolizumab and Tofacitinib dual targeted therapy.

The study will enroll approximately 65 patients. All the participants will be enrolled in a single treatment group to receive dual targeted treatment with Vedolizumab and Tofacitinib for the first 8 weeks:

Vedolizumab 300 mg + Tofacitinib 10 mg

Only those participants who show a clinical response at Week 8 will transition to Vedolizumab monotherapy for 44 weeks.

This multi-center trial will be conducted in the United States and Canada. The overall duration of the study is up to 76 weeks. Participants will be followed up for 26 weeks after the last dose of the study drug for safety.

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Official Title
An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Conditions
Ulcerative Colitis
Intervention / Treatment
  • Drug: Vedolizumab
  • Drug: Tofacitinib
  • Drug: Vedolizumab
  • Drug: Tofacitinib
Other Study ID Numbers
  • Vedolizumab-4054
Study Start (Actual)
2024-06-12
Primary Completion (Estimated)
2027-07-09
Study Completion (Estimated)
2027-07-09
Enrollment (Estimated)
65
Study Type
Interventional
Phase
Phase 4

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

Study Contact

Name: Takeda Contact

Phone Number: +1-877-825-3327

Email: medinfoUS@takeda.com

This study has 50 locations
United States
Alabama Locations
Dothan, Alabama, United States, 36301

Recruiting

Digestive Health Specialsits
Contact:
Site Contact
334-836-1212
Ralbares.research@dothangi.com
Principal Investigator:
Robert Albares
California Locations
Los Angeles, California, United States, 90048

Recruiting

Cedars-Sinai Medical Center
Contact:
Site Contact
310-423-4100
Andres.Yarur@cshs.org
Principal Investigator:
Andres Yarur
Newport Beach, California, United States, 92663

Not yet recruiting

Hoag Hospital Newport Beach
Contact:
Site Contact
323-442-6151
aroline.hwang@usc.edu
Principal Investigator:
Caroline Hwang
Florida Locations
Orlando, Florida, United States, 32803

Recruiting

Endoscopic Research Inc
Contact:
Site Contact
407-896-1726
levinepi@cdhfl.com
Principal Investigator:
Henry Levine
Tampa, Florida, United States, 33615

Recruiting

Alliance Clinical Research of Tampa, LLC
Contact:
Site Contact
813-515-5400
crespo@allianceclinicalresearch.com
Principal Investigator:
Israel Crespo
Georgia Locations
Roswell, Georgia, United States, 30076

Recruiting

Gastroenterology Consultants, P.C.
Contact:
Site Contact
404-596-4480
Mel7315@Yahoo.com
Principal Investigator:
Melvin Bullock
Illinois Locations
Chicago, Illinois, United States, 60637

Not yet recruiting

University of Chicago Medicine
Contact:
Site Contact
177-384-7414
kkearney@bsd.uchicago.edu
Principal Investigator:
David Rubin
Glenview, Illinois, United States, 60026

Recruiting

GI Alliance - Illinois Gastroenterology Group - Glenview
Contact:
Site Contact
847-677-1170
nmerel@illinoisgastro.com
Principal Investigator:
Nina Merel
Gurnee, Illinois, United States, 60031

Recruiting

GI Alliance - Illinois Gastroenterology Group LLC - Gurnee
Contact:
Site Contact
847-244-2960
rosenberg@illinoisgastro.com
Principal Investigator:
Jonathan Rosenberg
Kansas Locations
Kansas City, Kansas, United States, 66160

Not yet recruiting

University of Kansas Medical Center
Contact:
Site Contact
913-588-3934
tesfandyari@kumc.edu
Principal Investigator:
Tuba Esfandyari
Kentucky Locations
Louisville, Kentucky, United States, 40202

Not yet recruiting

University of Louisville
Contact:
Site Contact
502-419-5150
gerald.dryden@louisville.edu
Principal Investigator:
Gerald Dryden
Louisiana Locations
Metairie, Louisiana, United States, 70006

Recruiting

GI Alliance
Contact:
Site Contact
504-456-8020
catinis@metrogi.com
Principal Investigator:
George Catinis
Maryland Locations
Chevy Chase, Maryland, United States, 20815

Not yet recruiting

Capital Digestive Care - MGG Group - Chevy Chase Clinical Research
Contact:
Site Contact
301-652-5520
erica.cohen@capitaldigestivecare.com
Principal Investigator:
Erica Cohen
Michigan Locations
Clinton Township, Michigan, United States, 48038

Recruiting

Clinical Research Institute of Michigan, LLC
Contact:
Site Contact
586-598-3329
rfogel@researchmi.com
Principal Investigator:
Ronald Fogel
Ypsilanti, Michigan, United States, 48197

Recruiting

Huron Gastroenterology Associates, P.C.
Contact:
Site Contact
734-434-6262
soofin@hurongastro.com
Principal Investigator:
Najm Soofi
Minnesota Locations
Plymouth, Minnesota, United States, 55446

Recruiting

MNGI Digestive Health, PA
Contact:
Site Contact
612-871-1145
James.Campbell@mngi.com
Principal Investigator:
James Campbell
Missouri Locations
Kansas City, Missouri, United States, 64111

Recruiting

Mid-America Gastro-Intestinal Consultants
Contact:
Site Contact
816-561-2000
hbownik@gimagic.com
Principal Investigator:
Hillary Bownik
Liberty, Missouri, United States, 64068

Recruiting

BVL Clinical Research
Contact:
Site Contact
800-407-9314
c.bartalos@bvlresearch.com
Principal Investigator:
Christopher Bartalos
Saint Louis, Missouri, United States, 63110

Recruiting

Washington University School of Medicine
Contact:
Site Contact
314-273-1947
Deepak.parakkal@wustl.edu
Principal Investigator:
Parakkal Deepak
New York Locations
New York, New York, United States, 10016

Not yet recruiting

Inflammatory Bowel Disease Center at NYU Langone
Contact:
Site Contact
David.Hudesman@nyulangone.org
Principal Investigator:
David Hudesman
New York, New York, United States, 10065

Not yet recruiting

Weill Cornell Medical College- New York Presbyterian Hospital
Contact:
Site Contact
646-697-0985
djl9010@med.cornell.edu
Principal Investigator:
Dana Lukin
North Carolina Locations
Asheville, North Carolina, United States, 28801

Not yet recruiting

Digestive Health Partners - Asheville Gastroenterology Associate
Contact:
Site Contact
828-254-0881
wharlan@ncdhp.com
Principal Investigator:
William Harlan III
Chapel Hill, North Carolina, United States, 27599-7080

Recruiting

University of North Carolina
Contact:
Site Contact
919-962-3112
edward_barnes@med.unc.edu
Principal Investigator:
Edward Barnes
Raleigh, North Carolina, United States, 27612

Recruiting

Wake Research Associates, LLC
Contact:
Site Contact
919-781-2514
ahira@wakeresearch.com
Principal Investigator:
Angela Hira
Ohio Locations
Cincinnati, Ohio, United States, 45627

Not yet recruiting

University of Cincinnati
Contact:
Site Contact
513-558-5504
defelikm@ucmail.uc.edu
Principal Investigator:
Kara De Felice
Columbus, Ohio, United States, 43202

Recruiting

Ohio Gastroenterology group, Inc.
Contact:
Site Contact
614-754-5481
research@ohiogastro.com
Principal Investigator:
Ryan Gaible
Westlake, Ohio, United States, 44145

Recruiting

Gastro Intestinal Research Institute of Northern Ohio, LLC.
Contact:
Site Contact
440-250-7630
mnaem@northshoregastro.org
Principal Investigator:
Mohamed S Naem
Oklahoma Locations
Oklahoma City, Oklahoma, United States, 73102

Recruiting

Hightower Clinical - SSM Health
Contact:
Site Contact
405-479-8331
ali@hightowerclinical.com
Principal Investigator:
Tauseef Ali
Pennsylvania Locations
Wexford, Pennsylvania, United States, 15090

Not yet recruiting

Allegheny Health Network
Contact:
Site Contact
412-359-8900
gursimran.kochhar@ahn.org
Principal Investigator:
Gursimran Kochhar
Rhode Island Locations
Providence, Rhode Island, United States, 02905

Recruiting

University Gastroenterology
Contact:
Site Contact
401-421-8800
Sheldon_lidofsky@brown.edu
Principal Investigator:
Sheldon Lidofsky
South Dakota Locations
Rapid City, South Dakota, United States, 57701

Recruiting

Rapid City Medical Center, LLP
Contact:
Site Contact
605-342-3280
Gitex66@gmail.com
Principal Investigator:
Blake Jones
Texas Locations
Dallas, Texas, United States, 75044

Recruiting

GI Alliance - Digestive Health Associates of Texas
Contact:
Site Contact
972-265-8201
harry.sarles@gialliance.com
Principal Investigator:
Harry E. Sarles
Houston, Texas, United States, 77030

Not yet recruiting

The University of Texas Health Science Center at Houston
Contact:
Site Contact
713-500-6677
Andrew.Dupont@uth.tmc.edu
Principal Investigator:
Andrew Dupont
Mansfield, Texas, United States, 76063

Recruiting

GI Alliance - Mansfield
Contact:
Site Contact
817-877-0888
moustafa.youssef@dhat.com
Principal Investigator:
Moustafa Youssef
San Antonio, Texas, United States, 78229

Recruiting

Gastroenterology Research of San Antonio, LLC
Contact:
Site Contact
martinezn2@yahoo.com
Principal Investigator:
Nicholas Martinez
Southlake, Texas, United States, 76092

Recruiting

Texas Digestive Disease Consultants (TDDC), Southlake
Contact:
Site Contact
940-367-2316
Tim.Ritter@gialliance.com
Principal Investigator:
Timothy Ritter
Tyler, Texas, United States, 75701

Recruiting

Tyler Research Institute, LLC
Contact:
Site Contact
903-630-6211
aarond@tylerri.com
Principal Investigator:
George Aaron DuVall
Webster, Texas, United States, 77598

Recruiting

GI Alliance - Webster
Contact:
Site Contact
832-754-8163
NInamdar@tddctx.com
Principal Investigator:
Nikhil Inamdar
Utah Locations
Salt Lake City, Utah, United States, 84108

Not yet recruiting

University of Utah Health
Contact:
Site Contact
john.valentine@hsc.utah.edu
Principal Investigator:
John Valentine
Washington Locations
Bellevue, Washington, United States, 98004

Recruiting

Washington Gastroenterology- GIA
Contact:
Site Contact
425-454-4768
vmohan@washgi.com
Principal Investigator:
Venkatachala Mohan
Tacoma, Washington, United States, 98405

Recruiting

Washington Gastroenterology- GIA
Contact:
Site Contact
253-272-5127
wholderman@washgi.com
Principal Investigator:
William Holderman
Canada
Ontario Locations
Barrie, Ontario, Canada, L4M 7G1

Recruiting

Barrie GI Associates Inc.
Contact:
Site Contact
705-721-3344
petroniener@barriegi.ca
Principal Investigator:
Rima Petroniene
London, Ontario, Canada, N6A 5A5

Recruiting

London Health Sciences Centre
Contact:
Site Contact
519-685-8500
vipul.jairath@lhsc.on.ca
Principal Investigator:
Vipul Jairath
Mississauga, Ontario, Canada, L5M 7N4

Recruiting

West GTA Endoscopy Inc.
Contact:
Site Contact
905-823-0223
arif.m.yusuf@gmail.com
Principal Investigator:
Yusuf Arif
North Bay, Ontario, Canada, P1B 2H3

Recruiting

Viable Clinical Research - North Bay
Contact:
Site Contact
(705) 476-7737
stephanemg@yahoo.com
Principal Investigator:
Stephane Gauthier
North York, Ontario, Canada, M6A3B4

Recruiting

Toronto Immune and Digestive Health Institute Inc. (TIDHI)
Contact:
Site Contact
16478122113
msilverberg@tidhi.ca
Principal Investigator:
Mark Silverberg
Oakville, Ontario, Canada, L6L 5L7

Recruiting

ABP Research Services Corp.
Contact:
Site Contact
1905849068
narya1167@gmail.com
Principal Investigator:
Naveen Arya
Oshawa, Ontario, Canada, L1J 0C7

Recruiting

Taunton Surgical Centre
Contact:
Site Contact
905-723-8551
Daniel@drgreengi.com
Principal Investigator:
Daniel Green
Vaughan, Ontario, Canada, L4L 4Y7

Not yet recruiting

Toronto Digestive Disease Associates (TDDA) Specialty Research
Contact:
Site Contact
416-650-0017
lroth@tdda.ca
Principal Investigator:
Lee Roth
Quebec Locations
Montreal, Quebec, Canada, H3G 1A4

Not yet recruiting

McGill University Health Centre Montreal General Hospital
Contact:
Site Contact
514-934-1934
talat.bessissow@mcgill.ca
Principal Investigator:
Talat Bessissow
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  1. Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
  2. Has moderately to severely active UC as determined by a complete Mayo score [including physician's global assessment (PGA)] of 6 to 12 with a rectal bleeding subscore ≥>1 and a centrally assessed endoscopic subscore ≥2 at screening.
  3. Has evidence of UC extending proximally to the rectum [≥15 centimeter (cm) of involved colon].
  4. Participants with extensive colitis or pancolitis of >8 years duration or left sided colitis >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
  5. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up to date on colorectal cancer surveillance.
  6. Has demonstrated an inadequate response to, loss of response to, or intolerance to no more than 2 TNF antagonists.
  7. If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 20 milligrams per day (mg/day) of prednisone or equivalent for at least 4 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.

Exclusion Criteria:

Gastrointestinal Exclusion criteria:

  1. Has any of the following UC-related complications:

    1. Acute severe UC.
    2. The participant has had extensive colonic resection, subtotal or total colectomy.
    3. The participant has clinical evidence of abdominal abscess or toxic megacolon.
    4. The participant has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
    5. Short bowel syndrome.
  2. Has Crohn's colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID) induced colitis, idiopathic colitis (i.e, colitis not consistent with UC), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
  3. Has uncontrolled primary sclerosing cholangitis.

Infectious Disease Exclusion Criteria:

  1. Has any evidence of an active infection during screening.
  2. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:

    a. History of TB. b. A diagnostic TB test performed during screening that is positive, as defined by: i. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests or ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in subjects receiving the equivalent of >15 mg/day prednisone).

  3. A positive test for hepatitis B virus (HBV).
  4. A positive test for hepatitis C virus (HCV).
  5. Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen within 28 days prior to first dose of study treatment.

7. Evidence of active Cytomegalovirus (CMV) infection at screening.

Medication exclusion criteria:

  1. Has received immunomodulators (eg, 6-mercaptopurine, azathioprine, and methotrexate) within 4 weeks prior to first dose or immunosuppressants (eg, cyclosporine, tacrolimus) within 8 weeks prior to first dose.
  2. Any medicinal product, herbal medication, or natural health product which might interfere with cytochrome P450 genotype 3A4 (CYP3A4) within 2 weeks prior to enrollment.
  3. Has received any of the following medical therapies for UC:

    1. IV antibiotics within 8 weeks prior to enrollment.
    2. Any rectal therapy for treatment of UC within 2 weeks prior to screening endoscopy.
    3. NSAIDs as long-term treatment, defined as use for at least 4 days a week each month (>100 milligrams (mg) daily or acetaminophen and aspirin >325 mg daily.)
  4. Has received a live virus or live bacterial vaccine within 4 weeks prior to enrollment, or planned vaccination during the study and for 12 weeks after last dose.

General Exclusion Criteria:

  1. Has any of the following cardiovascular or thrombotic conditions:

    1. Recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.
    2. Recent (within past 6 months) moderate to severe congestive heart failure (New York Heart Association class III or IV).
    3. Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism.
    4. Known inherited conditions that predispose to hypercoagulability.
  2. History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
  3. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to undergo major surgery during the study period.
  4. Any investigational procedure ≤4 weeks prior to screening.
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Ages Eligible for Study
18 Years to 65 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

/
Design Details
Primary Purpose : Treatment
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Vedolizumab 300 mg + Tofacitinib 10 mg
Participants will receive Vedolizumab 300 mg , intravenous (IV) infusion, at Week 0, Week 2 and Week 6 along with Tofacitinib 10 mg, tablets, orally, twice daily from Week 0 to Week 8. Participants with clinical response at Week 8 will transition to receive vedolizumab 300 mg IV infusion every 8 weeks (Q8W) through Week 46.
Intervention/Treatment Drug: Vedolizumab
  • Vedolizumab IV infusions

  • Other Names:
    • Entyvio
    • MLN0002
Drug: Tofacitinib
  • Tofacitinib Tablets

  • Other Names:
    • Xeljanz
    • CP-690
    • CP-550
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo ScoreClinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore >1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Week 8
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo ScoreClinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore >1 at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a Physician's Global Index (PGA) and Mayo endoscopic findings (MES). Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activityAt Week 52
Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo ScoreClinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore >1. Partial Mayo Score consists of 3 variables of the Mayo Clinic Score: stool frequency, rectal bleeding and PGA. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity..At Weeks 8, 14 and 26
Percentage of Participants Achieving Clinical Response at Weeks 2, 6, 8, 14, 26 and 52 Based on Complete or Partial Mayo ScoreClinical response based on complete Mayo Score is where a participant achieves a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline or a partial Mayo score of ≥2 points and ≥25% from baseline, if the complete Mayo score was not performed at the visit with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Weeks 2, 6, 8, 14, 26, and 52
Percentage of Participants Achieving Clinical Remission at Week 8 and Week 52 Based on Modified Mayo ScoreClinical remission based on modified Mayo Score is where a participant achieves component modified Mayo score of ≤2 with modified MES ≤1, rectal bleeding = 0, and stool frequency ≤1. Modified Mayo Score consists of 3 variables: stool frequency, rectal bleeding and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease. These scores are summed to give a total score range of 0 to 9 where higher scores indicate maximum disease activity.At Weeks 8 and 52
Percentage of Participants With Durable Clinical Remission at Week 8 and Week 52Durable clinical remission is defined as the clinical remission at Week 8 and Week 52. Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore >1 point at Weeks 8 and 52. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Week 8 and Week 52
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 8Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore >1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Week 8
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 8Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 8. Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore >1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Week 8
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 52Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore >1 point at Week 52. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Week 52
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 52Corticosteroid-free clinical remission is where a participant achieves corticosteroid-free clinical remission at Week 52, and was off corticosteroids at least 3 months prior to Week 52. Clinical remission is defined as complete Mayo Score of ≤2 points and no individual subscore >1 point at Week 8. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Week 52
Percentage of Participants Achieving Clinical Response at Week 8Clinical response based on complete Mayo Score is where a participant achieves a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The complete Mayo Clinic Score includes 4 variables: Stool frequency, rectal bleeding, a PGA and MES. Each variable is scored on a 4-point scale (0-3 points) where 0=none and 3=severe disease and summed to give a total disease activity score (range, 0-12), with higher scores representing more severe disease activity.At Week 8
Percentage of Participants With Mucosal Healing Based on MES at Week 52Mucosal healing is defined as MES ≤1 point at Week 52. MES is a subscale of the Mayo score, an instrument designed to measure disease activity of UC. The subscale is graded from 0 to 3 based on the findings on endoscopy were 0= Normal appearance of mucosa, 1=mild disease (erythema, decreased vascular pattern), 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3=severe disease (spontaneous bleeding, ulceration). Higher scores indicate more severe disease.At Week 52
Percentage of Participants With Histological Remission Based on Geboes Score at Week 52Histological remission is defined as Geboes score <2 at Week 52. The Geboes score is a histological grading system for assessing histological disease activity in UC. The Geboes score evaluates 7 histological features. It consists of 6 grades (0-6). Each of the grades is divided into subgrades, based on the severity of tissue abnormalities or the extent of inflammatory cell infiltration. The Geboes score ranges from 0.0 to 5.4, and higher grades are indicative of more severe disease activity.At Week 52
Change in C-Reactive Protein Levels (CRP) From BaselineCRP is a useful marker of inflammation in participants with inflammatory bowel disease (IBD). In participants with UC, elevated CRP has been associated with severe clinical activityBaseline to Weeks 2, 6, 8, 14, 26, 42 and 52
Change in Fecal Calprotectin Concentrations From BaselineFecal calprotectin is a biomarker for intestinal inflammatory activity.Baseline to Weeks 2, 6, 8, 14, 26, 42 and 52
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From BaselineThe IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.At Weeks 8, 26 and 52
Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From BaselineThe FACIT-F is a validated, 13-item questionnaire to assess fatigue in participants with a variety of chronic illnesses, including participants with IBD. Items are rated on a 5-point Likert scale and the total score ranges from 0 to 52 with lower scores representing greater fatigue.At Weeks 8, 26 and 52
Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not the occurrence is considered related to the study intervention.Up to 76 Weeks
Number of Participants With Clinically Significant Change in Vital Signs From BaselineVital signs will include body temperature, respiratory rate, blood pressure (resting more than 5 minutes), and pulse (resting more than 5 minutes).Up to 76 Weeks
Number of Participants With Clinically Significant Physical Examination FindingsA baseline physical examination (defined as the assessment before first dose of study medication) will consist of the following body systems: general appearance; HEENT (head, eyes, ears, nose, and throat); cardiovascular system; respiratory system; gastrointestinal system; dermatologic system; extremities; musculoskeletal system; nervous system; lymph nodes; and other. All subsequent physical examinations will assess clinically significant changes from the assessment prior to first dose examination.At Baseline and From Week 14 to Week 72
Number of Participants With Markedly Abnormal Laboratory ValuesStandard laboratory tests will include clinical chemistry, hematology, coagulation and urinalysis.Up to Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Takeda
Investigators
  • Study Director:Study Director,Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2023-10-18
First Submitted that Met QC Criteria
2023-10-18
First Posted
2023-10-23
Study Record Updates
Last Update Submitted that met QC Criteria
2024-11-13
Last Update Posted
2024-11-15
Last Verified
2024-11

More Information

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Keywords Provided by Takeda
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing Supporting Information Type
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
IPD Sharing Url
https://vivli.org/ourmember/takeda/(https://vivli.org/ourmember/takeda/)