ClinicalTrials.gg
Active, not recruitingNCT06095128Updated Oct 26, 2026

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

A Phase 4 interventional study of Vedolizumab and Tofacitinib in Ulcerative Colitis, sponsored by Takeda. Active, not recruiting at 45 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Takeda · Phase 4, Interventional, and Treatment

Updated Oct 26, 2026Now Active, not recruiting1 site removedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies testing vedolizumab in Colitis, Ulcerative — 5 open to participants now, 9 under way, 6 of them phase 3. vedolizumab · Colitis, Ulcerative.

Planned enrollment
25th of 38
60 · median 110
Started
2024
with 1 other
Phase 4
15 of 38
2 open now
Registered
33rd of 38
by date
Lead sponsor
22 of 38
Takeda

Among the 38 studies testing vedolizumab in Colitis, Ulcerative, this one is the 25th largest by planned enrollment, is one of 2 that started in 2024, is one of 15 in phase 4, and was the 33rd registered.

Colitis, Ulcerative

1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.

Browse Colitis, Ulcerative studies →

Open to participants now

5 of the 38 studies testing vedolizumab in Colitis, Ulcerative are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

About vedolizumab

vedolizumab: first FDA approval 2014 (ENTYVIO), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 38 studies testing vedolizumab in Colitis, Ulcerative, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Ulcerative Colitis

Browse trials for

Keywords

  • Drug Therapy
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 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.

Exclusion criteria

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 an 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. Participants with a history of colonic mucosal dysplasia are also excluded.
  3. Has uncontrolled primary sclerosing cholangitis.

Infectious Disease Exclusion Criteria:

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

    1. History of TB.
    2. 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 participants receiving the equivalent of >15 mg daily prednisone).

  3. A positive test for virus (HBV).
  4. A positive test for virus (HCV).
  5. 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.
  6. 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 (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 () within 2 weeks prior to enrollment, except for any CYP3A4 modulator used to treat a C. difficile or an intestinal pathogen infection at screening.
  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. 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).
  4. Has received a within 4 weeks prior to first 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 ( 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 procedure ≤4 weeks prior to screening that, in the investigator's opinion, may interfere with interpretation of study results.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Drug: Vedolizumab · Drug: Tofacitinib

Interventions

  • Vedolizumab IV infusions

    Also known as: Entyvio, MLN0002

  • Tofacitinib Tablets

    Also known as: Xeljanz, CP-690, CP-550

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At Week 8

Secondary outcomes

  1. 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.

    Time frame: At Week 52

  2. 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.

    Time frame: At Weeks 8, 14 and 26

  3. 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.

    Time frame: At Weeks 2, 6, 8, 14, 26, and 52

  4. 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.

    Time frame: At Weeks 8 and 52

  5. 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.

    Time frame: At Weeks 8 and 52

  6. 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.

    Time frame: At Week 8 and Week 52

  7. 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.

    Time frame: At Week 8

  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.

    Time frame: At Week 8

  9. 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.

    Time frame: At Week 52

  10. 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.

    Time frame: At Week 52

  11. 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.

    Time frame: At Week 8

  12. 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.

    Time frame: At Week 52

  13. 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.

    Time frame: At Week 52

  14. 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.

    Time frame: Baseline to Weeks 2, 6, 8, 14, 26, 38 and 52

  15. Change in Fecal Calprotectin Concentrations From Baseline

    Fecal calprotectin is a biomarker for intestinal inflammatory activity.

    Time frame: Baseline to Weeks 2, 6, 8, 14, 26, 38 and 52

  16. 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.

    Time frame: At Weeks 8, 26 and 52

  17. 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.

    Time frame: At Weeks 8, 26 and 52

  18. 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.

    Time frame: Up to 76 weeks

  19. 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).

    Time frame: Up to 76 weeks

  20. 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.

    Time frame: At Baseline and From Week 14 to Week 72

  21. Number of Participants With Markedly Abnormal Laboratory Values

    Standard laboratory tests will include clinical chemistry, hematology, coagulation and urinalysis.

    Time frame: Up to 76 weeks

07

Study locations

45 sites
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

Data sharing details ↗ · vivli.org

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Jul 2027, 36 months after the start.

Of 63 phase 4 interventional studies under Colitis, Ulcerative, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 63. This study's planned 36 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2023
First posted
Oct 23, 2023
StartActual
Jun 12, 2024
Primary completionEst.
Jul 9, 2027
CompletionEst.
Jul 9, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 26, 2026
Sites
1 site removed
Show 1 removed
  • GI Alliance - Digestive Health Associates of Texas · Dallas, United States
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Recruiting→Active, not recruiting
    1 site removed
    Show 1 removed
    • GI Alliance - Digestive Health Associates of Texas · Dallas, United States
    + 3 other changes: verification date, contact details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06095128
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Jun 12, 2024
Primary completion
Jul 9, 2027 (estimated)
Completion
Jul 9, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Vedolizumab · Tofacitinib

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