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CompletedNCT02790138EARNESTUpdated Feb 24, 2022Results posted

A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

A Phase 4 interventional study of Vedolizumab Placebo and Ciprofloxacin in Pouchitis, sponsored by Takeda. Completed at 34 sites in 9 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Takeda · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.

Read the detailed description

Vedolizumab is being tested to treat people who have chronic pouchitis. This study will look at the healing of inflammation of ileal pouch in people who take vedolizumab as compared to those receiving a matching placebo. The study will enroll approximately 110 patients. Participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Vedolizumab 300 mg IV
  • Placebo IV

All participants will receive an intravenous infusion at Day 1, Weeks 2, 6, 14, 22, and 30 along with concomitant antibiotic treatment with ciprofloxacin 500 mg twice daily through Week 4.

This multicenter trial will be conducted in North America and Europe. The overall time to participate in treatment and efficacy assessment of this study is 34 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after the last dose of study drug for a safety follow-up assessment (up to Week 48). Participants will also participate in a long-term follow-up, by phone after the last dose of study drug up to Week 56.

02

Conditions studied

  • Pouchitis

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Keywords

  • Drug Therapy
03

In context

Pouchitis

50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.

This study's enrollment of 102 is above the median of 20 across 42 interventional studies indexed under Pouchitis.

Browse Pouchitis studies →

Lead sponsor

Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.

Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.

Browse Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 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. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, form and any required privacy authorization prior to the initiation of any study procedures.
  3. Has a history of ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) completed at least 1 year prior to the Day 1 (Randomization) Visit.
  4. Has pouchitis that is chronic or recurrent, defined by an modified pouchitis disease activity index (mPDAI) score ≥5 assessed as average from 3 days immediately prior to the Baseline endoscopy and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) ≥3 recurrent episodes within 1 year prior to the Screening Period treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the Baseline Endoscopy Visit.
  5. Agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study (additional courses of antibiotics will be allowed, as needed, for flares after Week 14).
  6. A male participant who is nonsterilized and sexually active with a female partner of agrees to use a barrier method of (e.g., condom with spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
  7. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.

Exclusion criteria

Exclusion Criteria:

Gastrointestinal Exclusion Criteria

  1. Has Crohn's disease (CD), or CD of the pouch.
  2. Has irritable pouch syndrome (IPS).
  3. Has isolated or predominant cuffitis.
  4. Has mechanical complications of the pouch (e.g., pouch stricture or pouch fistula).
  5. Currently requires or has a planned surgical intervention for UC during the study.
  6. Has diverting stoma.

Infectious Disease Exclusion Criteria 1. Has evidence of an active infection (e.g., sepsis, cytomegalovirus, or listeriosis) during Screening.

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

  1. A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, as defined by:

    1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests. OR

    2. A tuberculin skin test reaction ≥10 mm (≥5 mm in participants receiving the equivalent of >15 mg/day prednisone).

      OR

  2. Chest X-ray within 3 months prior to Day 1 that is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON test within 30 days prior to Screening or during the Screening Period.

    1. Has chronic virus (HBV) infection* or chronic virus (HCV) infection** or a known history of (HIV) infection (or is found to be seropositive at Screening) or participant is immunodeficient (e.g., due to organ transplantation, history of common variable immunodeficiency, etc).

    * Participants who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, HBV Deoxyribonucleic acid (DNA) polymerase chain reaction will be performed and if any test result meets or exceeds detection sensitivity, the participant will be excluded.

    • If participant is HCV antibody positive, then a viral load test will be performed. If the viral load test is positive then the participant will be excluded.

      1. Has evidence of active infection with Clostridium (C) difficile during Screening (to be confirmed by laboratory test)

    General Exclusion Criteria

    1. Has any prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or anti-mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
    2. Has a history of or allergies to vedolizumab or its components.
    3. Has allergies to and/or for ciprofloxacin, a history of tendon disorders related to quinolone administration and/or glucose-6-phosphate dehydrogenase (G6PD) deficiency. Further conditions requiring precautions for use of ciprofloxacin have to be considered based on local prescribing information.
    4. Is taking, has taken, or is required to take any excluded medications.
    5. Has received any or approved biologic or biosimilar agent within 60 days prior to Randomization.
    6. Has received an investigational nonbiologic therapy within 30 days prior to Randomization.
    7. Has received an approved nonbiologic therapy (including 5-aminosalicylate [5-ASA], , azathioprine, 6-mercaptopurine [6-MP], etc.) in an investigational protocol within 30 days prior to Randomization.
    8. Has received any within 30 days prior to randomization.
    9. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist at Screening.
    10. Has had a kidney, heart, or lung transplant.
    11. Has a history of , except for the following: adequately-treated non- basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to the Screening visit; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to Screening. Participants with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis prior to enrollment.
    12. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease.
    13. Has conditions, which in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.
    14. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.
    15. Has any of the following laboratory abnormalities during the Screening Period:

    <!-- -->

    1. level \<8 g/dL.
    2. White blood cell (WBC) count \<3 × 10\^9/L.
    3. Lymphocyte count \<0.5 × 10\^9/L.
    4. count \<100 × 10\^9/L or >1200 × 10\^9/L.
    5. (ALT) or aspartate aminotransferase (AST) >3 × the (ULN).
    6. Alkaline phosphatase >3 × ULN.
    7. Serum creatinine >2 × ULN.
    1. If female, the participant is pregnant or lactating or intending to become pregnant or nurse before, during, or within 18 weeks after the last dose of study medication; or intending to donate ova during such time period.
    1. If male, the participant intends to donate sperm or father a child during the course of this study or for 18 weeks after the last dose of study medication.
    1. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
    1. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to Screening.
Terms in these criteria, in plain language(17)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

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.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (actual)

Study arms

  • Placebo comparator
    Placebo IV

    Vedolizumab placebo-matching intravenous (IV) infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.

    Drug: Vedolizumab Placebo · Drug: Ciprofloxacin

  • Experimental
    Vedolizumab IV 300 mg

    Vedolizumab 300 mg, IV infusion, once at Day 1, Weeks 2, 6, 14, 22, and 30 along with ciprofloxacin 500 mg, tablet, orally twice daily up to Week 4.

    Drug: Vedolizumab

Interventions

  • DrugVedolizumab Placebo

    Vedolizumab placebo-matching IV infusion

  • DrugCiprofloxacin

    Ciprofloxacin tablets

  • DrugVedolizumab

    Vedolizumab IV infusion

    Also known as: Entyvio, MLN0002 IV, Kynteles

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 14

    Clinically relevant remission is defined as modified Pouchitis Disease Activity Index (mPDAI) score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease.

    Time frame: Week 14

Secondary outcomes

  1. Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 34

    Clinically relevant remission is defined as mPDAI score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease.

    Time frame: Week 34

  2. Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Weeks 14 and 34

    PDAI remission is PDAI score \<7 and a reduction of PDAI score by ≥3 points from Baseline. The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations. Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0(best) to 6(worst);3) Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%) where higher scores indicate more severe disease.

    Time frame: Weeks 14 and 34

  3. Time to PDAI Remission

    Time to remission-time in days from start of treatment to PDAI Remission(PDAI score \<7 and decrease in PDAI score ≥3 points from Baseline).18-point PDAI score-calculated as sum of 3, 6-point scales with total possible subscore of 0(best) to 6(worse) and possible total score of 0(best)to18(worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations.Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore=0(best) to 6(worst);3)Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%),higher scores=more severe disease.

    Time frame: Baseline up to Week 34

  4. Percentage of Participants Achieving a Partial mPDAI Response at Weeks 14 and 34

    Partial mPDAI response is defined as a reduction in mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst:1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease. Last observation carried forward (LOCF) method was used for analyses.

    Time frame: Weeks 14 and 34

  5. Change From Baseline in PDAI Endoscopic Inflammation Subscore at Weeks 14 and 34

    The PDAI Endoscopic Inflammation subscore is a sum of scores from findings for Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates, and Ulcerations, each scored on 0=not present to 1=present scale summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.

    Time frame: Baseline up to Weeks 14 and 34

  6. Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34

    The PDAI Acute Histologic Inflammation subscore is a sum score from findings for Polymorphic nuclear leukocyte infiltration (0=None to 3=Severe plus crypt abscess), and Ulceration per low power field \[mean\] (0=0% to 3= \>50%) summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.

    Time frame: Baseline up to Weeks 14 and 34

  7. Change From Baseline in Total PDAI Score at Weeks 14 and 34

    The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations. Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0(best) to 6(worst);3)Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%) where higher scores=more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.

    Time frame: Baseline up to Weeks 14 and 34

  8. Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34

    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 negative change from Baseline indicates worsening. LOCF method was used for analyses.

    Time frame: Baseline up to Weeks 14, 22, and 34

  9. Change From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34

    The CGQL (Fazio score) is a quality-of-life indicator specifically for participants with ileal pouch-anal anastomosis. Participants rate 3 items (current quality of life, current quality of health, and current energy level), each on a scale of 0 to 10 (0=worst; 10=best). The scores are added, and the final CGQL utility score is obtained by dividing this result by 30. The total score ranges from 0 (worst) to 1 (best) where lower scores indicate less quality of life. A negative change from Baseline indicates worsening. LOCF method was used for analyses.

    Time frame: Baseline up to Weeks 14, 22, and 34

07

Results

Posted Jun 30, 2021

Participant flow

Participants took part in the study at 31 investigative sites in Canada, United States, Belgium, France, Germany, Italy, Netherlands, Spain, and United Kingdom from 12 October 2016 to 2 February 2021.

Participant flow — Overall Study
MilestonePlacebo IVVedolizumab IV 300 mg
Started5151
Completed3032
Not completed2119
Withdrew: Adverse event52
Withdrew: Significant protocol deviation01
Withdrew: Lost to follow-up10
Withdrew: Voluntary withdrawal89
Withdrew: Lack of efficacy67
Withdrew: Reason not specified10

Outcome measures

PrimaryPercentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 14

Clinically relevant remission is defined as modified Pouchitis Disease Activity Index (mPDAI) score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=three or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease.

Time frame:
Week 14
Reported as:
Number · percentage of participants
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 14
percentage of participantsPlacebo IVVedolizumab IV 300 mg
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 149.8 (3.3 to 21.4)31.4 (19.1 to 45.9)
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Fisher's Exact Test · p = 0.013 (The significance level was 0.05.) · Percentage difference: 21.6 · 95% CI 4.9 to 37.5
SecondaryPercentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 34

Clinically relevant remission is defined as mPDAI score \<5 and a reduction of mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst.: 1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease.

Time frame:
Week 34
Reported as:
Number · percentage of participants
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 34
percentage of participantsPlacebo IVVedolizumab IV 300 mg
Percentage of Participants With Chronic or Recurrent Pouchitis Achieving Clinically Relevant Remission at Week 3417.6 (8.4 to 30.9)35.3 (22.4 to 49.9)
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Chi-squared Test · p = =0.043 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Percentage difference: 17.6 · 95% CI 0.3 to 35.1
SecondaryPercentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Weeks 14 and 34

PDAI remission is PDAI score \<7 and a reduction of PDAI score by ≥3 points from Baseline. The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations. Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0(best) to 6(worst);3) Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%) where higher scores indicate more severe disease.

Time frame:
Weeks 14 and 34
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Pouchitis Disease Activity Index (PDAI) Remission at Weeks 14 and 34
percentage of participantsPlacebo IVVedolizumab IV 300 mg
Week 149.8 (3.3 to 21.4)35.3 (22.4 to 49.9)
Week 3417.6 (8.4 to 30.9)37.3 (24.1 to 51.9)
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Fisher's Exact Test · p = =0.004 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Percentage difference: 25.5 · 95% CI 8.0 to 41.4
  • Placebo IV vs Vedolizumab IV 300 mg · Chi-squared Test · p = =0.027 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Percentage difference: 19.6 · 95% CI 1.9 to 37.0
SecondaryTime to PDAI Remission

Time to remission-time in days from start of treatment to PDAI Remission(PDAI score \<7 and decrease in PDAI score ≥3 points from Baseline).18-point PDAI score-calculated as sum of 3, 6-point scales with total possible subscore of 0(best) to 6(worse) and possible total score of 0(best)to18(worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations.Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore=0(best) to 6(worst);3)Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%),higher scores=more severe disease.

Time frame:
Baseline up to Week 34
Reported as:
Median · days
Time to PDAI Remission
daysPlacebo IVVedolizumab IV 300 mg
Time to PDAI RemissionNA (NA to NA)239.0 (101.0 to NA)
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Hazard ratio (hr): 3.95 · 95% CI 1.7 to 9.4Hazard ratio for achieving PDAI remission.
SecondaryPercentage of Participants Achieving a Partial mPDAI Response at Weeks 14 and 34

Partial mPDAI response is defined as a reduction in mPDAI score by ≥2 points from Baseline. The 12-point mPDAI score is calculated as a sum of from two 6-point subscales, where 0 = best and 12 = worst:1) Clinical Symptoms: Stool Frequency (0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual); Rectal bleeding (0=None or rare to 1=Present daily); Fecal urgency or abdominal cramps (0=None to 2=Usual), Fever \[temperature \>37.8 degrees C\] (0=Absent and 1=Present) for a clinical symptoms subscore of 0 (best) to 6 (worse); 2) Endoscopic Inflammation Findings: Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates and Ulcerations. Each item is scored on a scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0 (best) to 6 (worst) where higher scores indicate more severe disease. Last observation carried forward (LOCF) method was used for analyses.

Time frame:
Weeks 14 and 34
Reported as:
Number · percentage of participants
Percentage of Participants Achieving a Partial mPDAI Response at Weeks 14 and 34
percentage of participantsPlacebo IVVedolizumab IV 300 mg
Week 1433.3 (20.8 to 47.9)62.7 (48.1 to 75.9)
Week 3429.4 (17.5 to 43.8)51.0 (36.6 to 65.2)
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Chi-squared Test · p = =0.003 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Percentage difference: 29.4 · 95% CI 8.0 to 47.6
  • Placebo IV vs Vedolizumab IV 300 mg · Chi-squared Test · p = =0.026 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Percentage difference: 21.6 · 95% CI 1.9 to 39.8
SecondaryChange From Baseline in PDAI Endoscopic Inflammation Subscore at Weeks 14 and 34

The PDAI Endoscopic Inflammation subscore is a sum of scores from findings for Edema, Granularity, Friability, Loss of vascular pattern, Mucous exudates, and Ulcerations, each scored on 0=not present to 1=present scale summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.

Time frame:
Baseline up to Weeks 14 and 34
Reported as:
Mean · score on a scale
Change From Baseline in PDAI Endoscopic Inflammation Subscore at Weeks 14 and 34
score on a scalePlacebo IVVedolizumab IV 300 mg
Baseline4.5 ± 1.364.6 ± 1.15
Change from Baseline at Week 14-0.2 ± 1.36-1.1 ± 1.59
Change from Baseline at Week 34-0.6 ± 1.86-1.2 ± 1.87
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.002 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 2.02 · 95% CI 1.11 to 2.93P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.020 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.71 · 95% CI 0.92 to 2.49P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
SecondaryChange From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34

The PDAI Acute Histologic Inflammation subscore is a sum score from findings for Polymorphic nuclear leukocyte infiltration (0=None to 3=Severe plus crypt abscess), and Ulceration per low power field \[mean\] (0=0% to 3= \>50%) summed up to a subscore ranging from 0 (best) to 6 (worse) where higher scores = more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.

Time frame:
Baseline up to Weeks 14 and 34
Reported as:
Mean · score on a scale
Change From Baseline in PDAI Acute Histologic Inflammation Subscore at Weeks 14 and 34
score on a scalePlacebo IVVedolizumab IV 300 mg
Baseline2.6 ± 1.392.5 ± 1.42
Change from Baseline at Week 14-0.1 ± 1.33-0.4 ± 1.98
Change from Baseline at Week 34-0.2 ± 1.52-0.2 ± 2.03
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.191 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.34 · 95% CI 0.74 to 1.94P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.766 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.07 · 95% CI 0.60 to 1.54P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
SecondaryChange From Baseline in Total PDAI Score at Weeks 14 and 34

The 18-point PDAI score is calculated as a sum of three 6-point scales with total possible subscore of 0 (best) to 6 (worse) and possible total score of 0 (best) to 18 (worse):1)Clinical Symptoms:Stool Frequency(0=usual to postoperative stool frequency to 2=3 or more stools/day\>postoperative usual);Rectal bleeding(0=None or rare,1=Present daily);Fecal urgency/abdominal cramps(0=None to 2=Usual),Fever\[temperature\>37.8 degrees C\](0=Absent,1=Present);2)Endoscopic Inflammation:Edema,Granularity,Friability,Loss of vascular pattern,Mucous exudates,Ulcerations. Each item is scored on scale of 0=not present to 1=present summed up to an endoscopic subscore ranging from 0(best) to 6(worst);3)Acute Histologic Inflammation:Polymorphic nuclear leukocyte infiltration(0=None to 3=Severe plus crypt abscess),Ulceration per low power field\[mean\](0=0% to 3=\>50%) where higher scores=more severe disease. A negative change from Baseline indicates improvement. LOCF method was used for analyses.

Time frame:
Baseline up to Weeks 14 and 34
Reported as:
Mean · score on a scale
Change From Baseline in Total PDAI Score at Weeks 14 and 34
score on a scalePlacebo IVVedolizumab IV 300 mg
Baseline10.5 ± 2.4810.5 ± 2.20
Change from Baseline at Week 14-1.3 ± 2.68-2.7 ± 3.86
Change from Baseline at Week 34-1.6 ± 3.41-2.9 ± 3.93
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.055 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.57 · 95% CI 0.83 to 2.31P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.095 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.48 · 95% CI 0.79 to 2.16P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
SecondaryChange From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34

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 negative change from Baseline indicates worsening. LOCF method was used for analyses.

Time frame:
Baseline up to Weeks 14, 22, and 34
Reported as:
Mean · score on a scale
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 14, 22, and 34
score on a scalePlacebo IVVedolizumab IV 300 mg
Baseline131.5 ± 30.78137.9 ± 33.53
Change from Baseline at Week 1414.6 ± 26.6718.3 ± 29.20
Change from Baseline at Week 2216.0 ± 29.1221.3 ± 31.28
Change from Baseline at Week 3410.4 ± 25.9824.4 ± 34.21
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.575 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.14 · 95% CI 0.61 to 1.67P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.403 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.21 · 95% CI 0.65 to 1.78P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.047 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.60 · 95% CI 0.85 to 2.34P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
SecondaryChange From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34

The CGQL (Fazio score) is a quality-of-life indicator specifically for participants with ileal pouch-anal anastomosis. Participants rate 3 items (current quality of life, current quality of health, and current energy level), each on a scale of 0 to 10 (0=worst; 10=best). The scores are added, and the final CGQL utility score is obtained by dividing this result by 30. The total score ranges from 0 (worst) to 1 (best) where lower scores indicate less quality of life. A negative change from Baseline indicates worsening. LOCF method was used for analyses.

Time frame:
Baseline up to Weeks 14, 22, and 34
Reported as:
Mean · score on a scale
Change From Baseline in Cleveland Global Quality of Life (CGQL) at Weeks 14, 22, and 34
score on a scalePlacebo IVVedolizumab IV 300 mg
Baseline0.522 ± 0.19530.556 ± 0.1626
Change from Baseline at Week 140.051 ± 0.15180.088 ± 0.1715
Change from Baseline at Week 220.073 ± 0.14910.093 ± 0.1648
Change from Baseline at Week 340.056 ± 0.15440.083 ± 0.1831
Statistical analysis
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.119 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.44 · 95% CI 0.77 to 2.12P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.542 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.15 · 95% CI 0.62 to 1.69P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.
  • Placebo IV vs Vedolizumab IV 300 mg · Wilcoxon (Mann-Whitney) · p = =0.404 (No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.) · Odds estimator: 1.22 · 95% CI 0.65 to 1.78P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.

Adverse events

Collected over From first dose of study drug up to 18 weeks after last dose (Up to 50 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo IV0/51 (0%)4/51 (7.8%)35/51 (68.6%)
Vedolizumab IV 300 mg0/51 (0%)3/51 (5.9%)42/51 (82.4%)
Most frequent serious events
Most frequent serious events
EventPlacebo IVVedolizumab IV 300 mg
PouchitisGastrointestinal disorders1/512/51
Abdominal painGastrointestinal disorders1/510/51
Intestinal obstructionGastrointestinal disorders1/510/51
GastroenteritisInfections and infestations0/511/51
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/510/51
Most frequent other events
Showing 10 of 12
Most frequent other events
EventPlacebo IVVedolizumab IV 300 mg
PouchitisGastrointestinal disorders20/5123/51
HeadacheNervous system disorders3/5110/51
ArthralgiaMusculoskeletal and connective tissue disorders9/517/51
NasopharyngitisInfections and infestations6/516/51
NauseaGastrointestinal disorders5/515/51
Back painMusculoskeletal and connective tissue disorders5/512/51
Upper respiratory tract infectionInfections and infestations1/515/51
Abdominal painGastrointestinal disorders2/514/51
Frequent bowel movementsGastrointestinal disorders2/514/51
InfluenzaInfections and infestations1/514/51

Baseline characteristics

Full Analysis Set included all randomized participants who received at least 1 dose of study medication, as randomized.

Age, Continuous
Age, Continuous(years)Placebo IVVedolizumab IV 300 mgTotal
Mean42.9 ± 13.4840.8 ± 11.3241.9 ± 12.44
Sex: Female, Male
Sex: Female, Male(Participants)Placebo IVVedolizumab IV 300 mgTotal
Female131932
Male383270
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo IVVedolizumab IV 300 mgTotal
Hispanic or Latino000
Not Hispanic or Latino111223
Unknown or Not Reported403979
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo IVVedolizumab IV 300 mgTotal
American Indian or Alaska Native000
Asian639
Native Hawaiian or Other Pacific Islander000
Black or African American112
White424486
More than one race011
Unknown or Not Reported224
Region of Enrollment
Region of Enrollment(Participants)Placebo IVVedolizumab IV 300 mgTotal
Canada7916
United States111223
Belgium617
France257
Germany123
Italy101020
Netherlands6410
Spain101
United Kingdom7815
Height
Height(cm)Placebo IVVedolizumab IV 300 mgTotal
Mean175.3 ± 9.10172.4 ± 10.79173.8 ± 10.04
Weight
Weight(kg)Placebo IVVedolizumab IV 300 mgTotal
Mean79.60 ± 19.11572.13 ± 17.58875.87 ± 18.658
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Placebo IVVedolizumab IV 300 mgTotal
Mean25.74 ± 5.12524.13 ± 4.89124.93 ± 5.049
08

Study locations

34 sites
  • University of Chicago Medical Center
    Chicago, Illinois 60637, United States
  • Northshore University HealthSystem
    Evanston, Illinois 60201, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • University of North Carolina GI
    Chapel Hill, North Carolina 27599, United States
  • Carolinas HealthCare System Digestive Health
    Charlotte, North Carolina 28204, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212-1375, United States
  • Texas Digestive Disease Consultants
    Southlake, Texas 76092, United States
  • University of Utah Health Sciences Center
    Salt Lake City, Utah 84132, United States
  • UZ Leuven - University Hospital Gasthuisberg
    Leuven, 3000, Belgium
  • GIRI (GI Research Institute)
    Vancouver, British Columbia V6Z 2K5, Canada
  • Ottawa Hospital - General Campus
    Ottawa, Ontario K1H 8L6, Canada
  • Mount Sinai Hospital
    Toronto, Ontario M5G 1X5, Canada
  • CHU de Rennes - Hopital de Pontchaillou
    Rennes cedex 9, 35033, France
  • CHU Saint Etienne - Hopital Nord
    Saint-Priest en Jarez, 42270, France
  • CHU de Toulouse - Hopital Rangueil
    Toulouse cedex 9, 31059, France
  • CHRU Nancy Hopital de Brabois
    Vandoeuvre les Nancy, 54511, France
  • Charite Universitatsmedizin Berlin -Campus Virchow Klinikum
    Berlin, 13353, Germany
  • Asklepios Hospital Hamburg - West
    Hamburg, 22559, Germany
  • Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter
    Heidelberg, 69121, Germany
  • Universitatsklinikum Jena
    Jena, 07747, Germany
  • Klinikum Mannheim GmbH Universitaetsklinikum
    Mannheim, 68167, Germany
  • Azienda Ospedaliera S. Orsola-Malpighi
    Bologna, 40138, Italy
  • Azienda Ospedaliera di Padova
    Padova, 35128, Italy
  • Policlinico Gemelli
    Rome, 00168, Italy
  • Istituto Clinico Humanitas IRCCS
    Rozzano, 20089, Italy
  • Academic Medical Center
    Amsterdam, 1105 AZ, Netherlands
  • Maastricht University Medical Center
    Maastricht, 6229 HX, Netherlands
  • Hospital Doctor Negrin
    Las Palmas de Gran Canaria, 35010, Spain
  • Hospital Universitario y Politecnico La Fe
    Valencia, 46026, Spain
  • St. Mark's Hospital
    Harrow, HA1 3UJ, United Kingdom
  • Royal London Hospital
    London, E1 2EF, United Kingdom
  • John Radcliffe Hospital
    Oxford, OX3 9DU, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2016 to primary completion in Jun 2020, 43 months.

Results were first posted in Jun 2021, 1 year after primary completion.

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

Registered
May 26, 2016
First posted
Jun 3, 2016
StartActual
Oct 12, 2016
Primary completionActual
Jun 11, 2020
CompletionActual
Feb 2, 2021
Results first posted
Jun 30, 2021
Last update
Feb 24, 2022
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.
No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02790138
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jun 3, 2016
Start date
Oct 12, 2016
Primary completion
Jun 11, 2020
Completion
Feb 2, 2021
Results posted
Jun 30, 2021
Last update
Feb 24, 2022

Study contacts

Study Director
study director · Takeda

Oversight

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

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