Ulcerative ColitisPhase 4NCT06095128
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
A Phase 4 study testing Vedolizumab and Tofacitinib in people with Ulcerative Colitis, run by Takeda at 45 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Vedolizumab and Tofacitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 45 sitesin 2 countries
- Study dates
- 12 Jun 2024to 9 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Has moderately to severely active UC as determined by a complete Mayo score [including PGA] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.
- Has evidence of UC extending proximally to the rectum [≥15 centimeter (cm) of involved colon].
- 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.
- 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.
- Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Determination of inadequate response, loss of response, or intolerance is based upon investigator's clinical judgment. Participants who discontinued TNFα antagonist therapy for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the medical monitor.
- Note: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy per standard of care treatment without prior exposure to biologics may be enrolled if deemed appropriate. Determination of inadequate response, loss of response, or intolerance is based upon investigator's clinical judgment. Participants who discontinued biologics for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the Medical Monitor. If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 40 mg daily of prednisone or 9 mg daily of budesonide, or equivalent for at least 2 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids.
Who cannot join
- Gastrointestinal Exclusion criteria:
- Has any of the following UC-related complications:
- Acute severe UC.
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has clinical evidence of abdominal abscess or toxic megacolon.
- The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Show all 36Show fewer
- Short bowel syndrome.
- 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. Participants with a history of colonic mucosal dysplasia are also excluded.
- Has uncontrolled primary sclerosing cholangitis.
- Infectious Disease Exclusion Criteria:
- Has any evidence of an active systemic infection during screening. Participants with nonsystemic infections (eg, active fungal infection of nail beds) may be eligible, if in the opinion of the investigator, inclusion of the participant will not interfere with the collection or interpretation of study results and poses no risk to the participant.
- Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
- History of TB.
- A diagnostic TB test performed during screening that is positive, as defined by:
- A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests or ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of >15 mg daily prednisone).
- A positive test for hepatitis B virus (HBV).
- A positive test for hepatitis C virus (HCV).
- Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen during screening. Participants who test positive for C. difficile or other intestinal pathogens at screening and receive treatment may be enrolled or rescreened (if required) following confirmation of infection resolution.
- Evidence of active Cytomegalovirus (CMV) infection at screening.
- Medication exclusion criteria:
- 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.
- Any medicinal product, herbal medication, or natural health product which might interfere with cytochrome P450 genotype 3A4 (CYP3A4) within 2 weeks prior to enrollment, except for any CYP3A4 modulator used to treat a C. difficile or an intestinal pathogen infection at screening.
- Has received any of the following medical therapies for UC:
- IV antibiotics within 8 weeks prior to enrollment.
- Any rectal therapy for treatment of UC within 2 weeks prior to screening endoscopy.
- Chronic NSAID use defined as daily use for >2 consecutive weeks (Note: occasional use [<2 consecutive weeks] of NSAIDs and acetaminophen [<100 mg daily] for headache, arthritis, myalgias, or menstrual cramps and chronic low dose aspirin use [81-162.5 mg daily] for cardiovascular prophylaxis are permitted).
- Has received a live vaccine within 4 weeks prior to first dose.
- General Exclusion Criteria:
- Has any of the following cardiovascular or thrombotic conditions:
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.
- Recent (within past 6 months) moderate to severe congestive heart failure (New York Heart Association class III or IV).
- Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism.
- Known inherited conditions that predispose to hypercoagulability.
- History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to undergo major surgery during the study period.
- Any investigational procedure ≤4 weeks prior to screening that, in the investigator's opinion, may interfere with interpretation of study results.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States36 sites
Digestive Health Partners
Asheville, North Carolina, 28801
University of North Carolina
Chapel Hill, North Carolina, 27599
Capital Digestive Care - MGG Group - Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
University of Chicago Medicine
Chicago, Illinois, 60637
University of Cincinnati
Cincinnati, Ohio, 45627
Ohio Gastroenterology group, Inc.
Columbus, Ohio, 43202
Digestive Health Specialsits
Dothan, Alabama, 36301
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Mid-America Gastro-Intestinal Consultants
Kansas City, Missouri, 64111
BVL Clinical Research
Liberty, Missouri, 64068
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Louisville
Louisville, Kentucky, 40202
GI Alliance - Mansfield
Mansfield, Texas, 76063
GI Alliance
Metairie, Louisiana, 70006
Tulane University
New Orleans, Louisiana, 70112
NYU Langone Health
New York, New York, 10016
Weill Cornell Medical College- New York Presbyterian Hospital
New York, New York, 10065
Hoag Hospital Newport Beach
Newport Beach, California, 92663
Endoscopic Research Inc
Orlando, Florida, 32803
MNGI Digestive Health, PA
Plymouth, Minnesota, 55446
University Gastroenterology
Providence, Rhode Island, 02094
Sanford Health Research
Rapid City, South Dakota, 57701
Gastroenterology Consultants, P.C.
Roswell, Georgia, 30076
University of Utah Health
Salt Lake City, Utah, 84108
Gastroenterology Research of San Antonio, LLC
San Antonio, Texas, 78229
Texas Digestive Disease Consultants (TDDC), Southlake
Southlake, Texas, 76092
Washington University School of Medicine
St Louis, Missouri, 63110
GI Alliance Sun City
Sun City, Arizona, 85351
Washington Gastroenterology- GIA
Tacoma, Washington, 98405
Alliance Clinical Research of Tampa, LLC
Tampa, Florida, 33615
Tyler Research Institute, LLC
Tyler, Texas, 75701
GI Alliance - Webster
Webster, Texas, 77598
Gastro Intestinal Research Institute of Northern Ohio, LLC.
Westlake, Ohio, 44145
Allegheny Health Network
Wexford, Pennsylvania, 15090
Huron Gastroenterology Associates, P.C.
Ypsilanti, Michigan, 48197
Canada9 sites
Barrie GI Associates Inc.
Barrie, Ontario, L4M 7G1
London Health Sciences Centre
London, Ontario, N6A 5A5
West GTA Endoscopy Inc.
Mississauga, Ontario, L5M 7N4
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3G 1A4
Viable Clinical Research - North Bay
North Bay, Ontario, P1B 2H3
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
North York, Ontario, M6A3B4
ABP Research Services Corp.
Oakville, Ontario, L6L 5L7
Taunton Surgical Centre
Oshawa, Ontario, L1J 0C7
Toronto Digestive Disease Associates (TDDA) Inc.
Vaughan, Ontario, L4L 4Y7
About this study
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
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.
Read the 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 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 60 participants. 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Vedolizumab, Tofacitinib
- Keywords
- Drug Therapy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Also called Entyvio, MLN0002
Vedolizumab IV infusions
TofacitinibDrug
Also called Xeljanz, CP-690, CP-550
Tofacitinib Tablets
| Study group | Role | What they receive |
|---|---|---|
| Vedolizumab 300 mg + Tofacitinib 10 mg | Experimental | 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. Receives: Drug: Vedolizumab; Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score
Clinical 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.
Measured: At Week 8
Secondary outcomes (21)
Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo Score
Clinical remission based on complete Mayo Score is where a participant achieves complete Mayo Score ≤2 points with no individual subscore >1 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.
Measured: At Week 52
Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo Score
Clinical remission based on complete Mayo Score is where a participant achieves partial 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.
Measured: 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 Score
Clinical 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.
Measured: 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 Score
Clinical 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.
Measured: At Weeks 8 and 52
Percentage of Participants With Endoscopic Improvement at Week 8 and Week 52 Based on Modified Mayo Endoscopic Subscore (MMES)
Endoscopic improvement based on modified mayo endoscopic score is where participants achieve MMES ≤1 point. 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.
Measured: At Weeks 8 and 52
Percentage of Participants With Durable Clinical Remission at Week 8 and Week 52
Durable 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.
Measured: At Week 8 and Week 52
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving 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.
Measured: At Week 8
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 8
Corticosteroid-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.
Measured: At Week 8
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 52
Clinical 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.
Measured: At Week 52
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 52
Corticosteroid-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.
Measured: At Week 52
Percentage of Participants Achieving Clinical Response at Week 8
Clinical 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.
Measured: At Week 8
Percentage of Participants With Endoscopic Improvement at Week 52
Endoscopic improvement based on modified mayo score is where participants achieve MMES ≤1 point. 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.
Measured: At Week 52
Percentage of Participants With Histological Remission Based on Geboes Score at Week 52
Histological 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.
Measured: At Week 52
Change in C-Reactive Protein Levels (CRP) From Baseline
CRP 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 activity.
Measured: Baseline to Weeks 2, 6, 8, 14, 26, 38 and 52
Change in Fecal Calprotectin Concentrations From Baseline
Fecal calprotectin is a biomarker for intestinal inflammatory activity.
Measured: Baseline to Weeks 2, 6, 8, 14, 26, 38 and 52
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
The 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.
Measured: At Weeks 8, 26 and 52
Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline
The 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.
Measured: 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.
Measured: Up to 76 weeks
Number of Participants With Clinically Significant Change in Vital Signs From Baseline
Vital signs will include body temperature, respiratory rate, blood pressure (resting more than 5 minutes), and pulse (resting more than 5 minutes).
Measured: Up to 76 weeks
Number of Participants With Clinically Significant Physical Examination Findings
A 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.
Measured: At Baseline and From Week 14 to Week 72
Number of Participants With Markedly Abnormal Laboratory Values
Standard laboratory tests will include clinical chemistry, hematology, coagulation and urinalysis.
Measured: Up to 76 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start12 Jun 2024
- Primary completion9 Jul 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095128
- Sponsor's protocol ID
- Vedolizumab-4054
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06095128
- Acronym / sponsor ID
- Vedolizumab-4054
- Conditions
- Ulcerative Colitis
- Keywords
- Drug Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 60 participants. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab 300 mg + Tofacitinib 10 mg | Experimental | Drug: Vedolizumab, Drug: TofacitinibParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Has moderately to severely active UC as determined by a complete Mayo score [including PGA] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.
- Has evidence of UC extending proximally to the rectum [≥15 centimeter (cm) of involved colon].
- 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.
- 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.
Key exclusion criteria (36 listed)
- Has any of the following UC-related complications:
- 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. Participants with a history of colonic mucosal dysplasia are also excluded.
- Has uncontrolled primary sclerosing cholangitis.
- Has any evidence of an active systemic infection during screening. Participants with nonsystemic infections (eg, active fungal infection of nail beds) may be eligible, if in the opinion of the investigator, inclusion of the participant will not interfere with the collection or interpretation of study results and poses no risk to the participant.
- Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VedolizumabAlso: Entyvio, MLN0002Vedolizumab IV infusions | Drug | Vedolizumab 300 mg + Tofacitinib 10 mg |
| TofacitinibAlso: Xeljanz, CP-690, CP-550Tofacitinib Tablets | Drug | Vedolizumab 300 mg + Tofacitinib 10 mg |
Primary outcome
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score
Time frame: At Week 8
Clinical 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.
21 secondary outcomes
Percentage of Participants Achieving Clinical Remission at Week 52 Based on Complete Mayo Score
Time frame: At Week 52
Percentage of Participants Achieving Clinical Remission at Weeks 8, 14, and 26 Based on Partial Mayo Score
Time frame: 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 Score
Time frame: 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 Score
Time frame: At Weeks 8 and 52
Percentage of Participants With Endoscopic Improvement at Week 8 and Week 52 Based on Modified Mayo Endoscopic Subscore (MMES)
Time frame: At Weeks 8 and 52
Percentage of Participants With Durable Clinical Remission at Week 8 and Week 52
Time frame: At Week 8 and Week 52
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 8
Time frame: At Week 8
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 8
Time frame: At Week 8
Percentage of Participants Using Oral Corticosteroids at Baseline Achieving Clinical Remission at Week 52
Time frame: At Week 52
Percentage of Participants With Corticosteroid-Free Clinical Remission at Week 52
Time frame: At Week 52
Percentage of Participants Achieving Clinical Response at Week 8
Time frame: At Week 8
Percentage of Participants With Endoscopic Improvement at Week 52
Time frame: At Week 52
Percentage of Participants With Histological Remission Based on Geboes Score at Week 52
Time frame: At Week 52
Change in C-Reactive Protein Levels (CRP) From Baseline
Time frame: Baseline to Weeks 2, 6, 8, 14, 26, 38 and 52
Change in Fecal Calprotectin Concentrations From Baseline
Time frame: Baseline to Weeks 2, 6, 8, 14, 26, 38 and 52
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline
Time frame: At Weeks 8, 26 and 52
Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline
Time frame: At Weeks 8, 26 and 52
Number of Participants With Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)
Time frame: Up to 76 weeks
Number of Participants With Clinically Significant Change in Vital Signs From Baseline
Time frame: Up to 76 weeks
Number of Participants With Clinically Significant Physical Examination Findings
Time frame: At Baseline and From Week 14 to Week 72
Number of Participants With Markedly Abnormal Laboratory Values
Time frame: Up to 76 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vedolizumab and Tofacitinib in people with Ulcerative Colitis, run by Takeda at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score (time frame: At Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.