Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

November 25, 2020 updated by: Takeda

A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD. This study will look at the PK, efficacy, immunogenicity, safety, and tolerability in participants who take vedolizumab.

The study will enroll approximately 80 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two dose regimens (high or low) per weight group >=30 kg and 10 kg to <30 kg in ratio 1:1-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • Vedolizumab high dose group - Vedolizumab 300 mg or 200 mg
  • Vedolizumab low dose group - Vedolizumab 150 mg or 100 mg

All participants will be administered vedolizumab via IV infusion. Participants assigned to the low dose group who do not achieve clinical response (based on pediatric UC/CDAI) at Week 14 will receive the high dose (that is, 300 mg for participants >=30 kg baseline weight and 200 mg for participants 10 kg to <30 kg baseline weight) of vedolizumab IV at Week 14. Participants assigned to the high dose group who had not achieved clinical response continued on the same blinded high dose at Week 14.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 36 weeks. After completing the Week 22 Visit procedures, eligible participants may enter a blinded extension study. Participants will make multiple visits to the clinic, and those who do not enter extension study will have a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants who do not enter the extension study will also participate in a long-term safety follow-up, by telephone, 6 months after the last dose of study drug.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
    • Brussels
      • Brussel, Brussels, Belgium, 1090
        • Universitair Ziekenhuis Brussel
      • Bruxelles, Brussels, Belgium, 1020
        • Hopital Universitaire des Enfants Reine Fabiola
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Universitair Ziekenhuis Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1C9
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's and Women's Health Centre of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1S1
        • Children's Hospital of Winnipeg
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre University Hospital
      • Toronto, Ontario, Canada, M5G 1X8
        • Toronto Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Centre Hospitalier Universitaire Sainte-Justine
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre Glen Site
  • France
    • Ile-de-france
      • Paris Cedex 15, Ile-de-france, France, 75015
        • Hôpital Necker-Enfants Malades
      • Paris Cedex 19, Ile-de-france, France, 75935
        • Hopital Robert Debre
    • NORD Pas-de-calais
      • Lille, NORD Pas-de-calais, France, 59037
        • Hôpital Jeanne de Flandre
    • Provence Alpes COTE D'azur
      • Marseille Cedex 5, Provence Alpes COTE D'azur, France, 13385
        • Hopital De La Timone
  • Germany
    • Baden-wuerttemberg
      • Ulm, Baden-wuerttemberg, Germany, 89075
        • Universitätsklinikum Ulm
    • Bayern
      • Munchen, Bayern, Germany, 80337
        • Ludwig-Maximillians-Universitat Munchen
    • Mecklenburg-vorpommern
      • Rostock, Mecklenburg-vorpommern, Germany, 18057
        • Universitatsmedizin Rostock - Kinder und Jugendklinik
    • Nordrhein-westfalen
      • Aachen, Nordrhein-westfalen, Germany, 52074
        • Universitätsklinikum Aachen
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitaetsklinikum Leipzig Aoer
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
    • Borsod-abauj-zemplen
      • Miskolc, Borsod-abauj-zemplen, Hungary, 3526
        • BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    • Gyor-moson-sopron
      • Sopron, Gyor-moson-sopron, Hungary, 9400
        • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet
    • Hajdu-bihar
      • Debrecen, Hajdu-bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
  • Israel
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus - Rambam Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
    • Beersheba
      • Beer-sheva, Beersheba, Israel, 8410101
        • Soroka university medical center
    • Petah Tiqwa
      • Petach Tikvah, Petah Tiqwa, Israel, 4920235
        • Schneider Children's Medical Center of Israel
    • Rehoboth
      • Zerifin, Rehoboth, Israel, 7030000
        • Assaf Harofeh Medical Center
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 52621
        • The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
  • Netherlands
    • GA
      • Nijmegen, GA, Netherlands, 6525
        • Radboud Universitair Medisch Centrum
    • Noord-holland
      • Amsterdam, Noord-holland, Netherlands, 1105AZ
        • Emma Kinderziekenhuis AMC
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Isala Klinieken
    • Zuid-holland
      • Rotterdam, Zuid-holland, Netherlands, 3015 GJ
        • Erasmus University Medical Center
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-369
        • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
    • Lodzkie
      • Lodz, Lodzkie, Poland, 91-738
        • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic
      • Lodz, Lodzkie, Poland, 93-338
        • Instytut Centrum Zdrowia Matki Polki
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-663
        • Uniwersytecki Szpital Dzieciecy w Krakowie
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 01-184
        • Warszawski Uniwersytet Medyczny
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-302
        • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-274
        • Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-803
        • COPERNICUS Podmiot Leczniczy
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-780
        • Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE
  • Ukraine
      • Kharkiv, Ukraine, 61093
        • Kharkiv Regional Clinical Children's Hospital
    • Kiev City
      • Kyiv, Kiev City, Ukraine, 03115
        • National Scientific Center of Radiological Medicine of NAMS of Ukraine
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B4 6NH
        • Birmingham Women's and Children's NHS Foundation Trust
      • Cambridge, England, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • London, England, United Kingdom, WC1N 3JH
        • Great Ormond street Hospital for Children NHS Trust
      • London, England, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, England, United Kingdom, E1 1BB
        • Barts and the London NHS Trust
      • Manchester, England, United Kingdom, M13 9WL
        • Central Manchester University Hospitals NHS Foundation Trust
      • Nottingham, England, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Oxford, England, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
      • Sheffield, England, United Kingdom, S10 2TH
        • Sheffield Children's NHS Foundation Trust
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • NHS Greater Glasgow and Clyde
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • San Francisco, California, United States, 94143-0135
        • University of California San Francisco
    • Connecticut
      • Hartford, Connecticut, United States, 06106-3322
        • Connecticut Children's Medical Center
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours Children's Clinic
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Childrens Specialty Care - Jacksonville
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Children's Center for Digestive Healthcare
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine - Indianapolis
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • New York
      • Bronx, New York, United States, 10467
        • The Children's Hospital at Montefiore
      • Lake Success, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10031
        • Columbia University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Rainbow Babies & Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75235
        • Childrens Medical Center of Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • University of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Specialty Group - Medical Center Location
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

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

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants weighs >=10 kg at the time of randomization.
  2. Has a medical history of moderately to severely active UC during Screening defined as complete Mayo score of 6 to 12, and a total Mayo subscores of stool frequency and rectal bleeding >=4 and Mayo endoscopy subscore >=2, or has moderately to severely active CD defined as simple endoscopic score for Crohn's disease (SES-CD) >=7, and the CDAI components of average daily abdominal pain score of greater than (>) 1 for the 7 days prior, and total number of liquid/very soft stools >10 within 7 days prior to first dose of study drug.
  3. Has evidence of UC extending proximal to the rectum (that is, not limited to proctitis) or evidence of CD involving the ileum and/or colon, at a minimum.
  4. Has extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months prior to their first dose of study drug.
  5. Has a family history of colorectal cancer (that is, first-degree relative), personal history of increased colorectal cancer risk, or other known risk factor must be up-to-date on colorectal cancer surveillance.
  6. The participant's vaccinations are up to date.

  7. Has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:

    Corticosteroids:

    • Signs and/or symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to or more than prednisone 1 milligram per kilogram (mg/kg) daily orally for 2 weeks or IV for 1 week.

    OR

    • Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally on 2 separate occasions.

    OR

    • History of significant intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).

    Immunomodulators:

    • Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (AZA) (>=1.5 milligram per kilogram per day [mg/kg/day]) or 6-mercaptopurine (6-MP) mg/kg (>=1.0 mg/kg/day) or methotrexate (MTX) (>=10 milligram per square meter [mg/m^2] once a week).

    OR

    • History of intolerance of at least 1 immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function test (LFT) abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, infection).

    Tumor necrosis factor-alpha (TNF-α) antagonists:

    • Signs and symptoms of persistently active disease despite a history of at least 1 induction regimen of infliximab 5 mg/kg IV at Week 0 and Weeks 2 and 6 or adalimumab 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15 if >=40 kg or 80 mg on Day 1 and 40 mg on Day 15 if <40 kg. For any other TNF-α antagonist, the participant must demonstrate signs and symptoms of persistently active disease despite a history of at least 1 induction regimen, as determined by the investigator.

    OR

    • Recurrence of symptoms during maintenance dosing following prior clinical benefit, that is, fitting clinically with secondary loss of response (discontinuation despite clinical benefit does not qualify).

    OR

    • History of intolerance of infliximab or adalimumab (including, but not limited to, infusion-related reaction, demyelination, congestive heart failure, infection).

  8. The participant may be receiving a therapeutic dose of the following drugs:

    1. Oral 5-aminosalicylic acid (5-ASA) compounds, providing the dose has been stable for the 2 weeks prior to first dose of study drug.
    2. Oral corticosteroid therapy (prednisolone at a stable dose <=50 mg/day, or equivalent steroid), provided that the dose has been stable for the 4 weeks prior to first dose of study drug if corticosteroids have been initiated, or for the 2 weeks prior to first dose of study drug if corticosteroids are being tapered.
    3. Probiotics (example, Saccharomyces boulardii), provided the dose has been stable for the 2 weeks prior to first dose of study drug.
    4. Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
    5. Antibiotics used for the treatment of CD (example, ciprofloxacin, metronidazole), providing the dose has been stable for the 2 weeks prior to first dose of study drug.
    6. Azathioprine or 6-MP, provided the dose has been stable for the 8 weeks prior to first dose of study drug.
    7. Methotrexate (MTX), provided the dose has been stable for the 8 weeks prior to first dose of study drug.

Exclusion Criteria:

  1. Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, or AMG 181) or MAdCAM-1 antagonists, or rituximab.
  2. Has had prior exposure to vedolizumab.
  3. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
  4. Requires surgical intervention for UC or CD, or is anticipated to require surgical intervention for UC or CD during this study.
  5. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug.
  6. Has any unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI), genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise participant safety.

  7. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, defined as:

    • Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
    • A TB skin test reaction >=5 millimeter (mm). Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
  8. Clinically significant current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
  9. Has a current diagnosis of indeterminate colitis (Inflammatory bowel disease unclassified [IBDU]). For participants less than 6 years of age, any findings that suggest monogenic very early onset inflammatory bowel disease should be excluded.
  10. Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
  11. Has ileostomy, colostomy, ileo-anal pouch, or known fixed symptomatic stenosis of the intestine.
  12. Has extensive colonic resection, example, subtotal or total colectomy.
  13. Has a history or evidence of adenomatous colonic polyps that have not been removed.
  14. Has a history or evidence of colonic mucosal dysplasia.
  15. Has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection. * HBV immune participants (that is, being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may be included, however.
  16. Has any identified congenital or acquired immunodeficiency (example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  17. Has evidence of or treatment for Clostridium difficile (C difficile) infection within 60 days or other intestinal pathogen within 30 days prior to first dose of study drug.
  18. Has any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to enrollment; and (c) history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to first dose of study drug. Participants with remote history of malignancy (example, >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received, and inclusion must be discussed with the sponsor on a case-by-case basis prior to enrollment.
  19. Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
  20. Has history of lupus.
  21. Has had a surgical procedure requiring general anesthesia within 30 days prior to screening or is planning to undergo major surgery during the study period.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: UC: <30 kg Participants, Vedolizumab 100 mg
Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
EXPERIMENTAL: UC: <30 kg Participants, Vedolizumab 200 mg
Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
EXPERIMENTAL: CD: <30 kg Participants, Vedolizumab 100 mg
Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
EXPERIMENTAL: CD: <30 kg Participants, Vedolizumab 200 mg
Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
EXPERIMENTAL: UC: >=30 kg Participants, Vedolizumab 150 mg
Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
EXPERIMENTAL: UC: >=30 kg Participants, Vedolizumab 300 mg
Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
EXPERIMENTAL: CD: >=30 kg Participants, Vedolizumab 150 mg
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
EXPERIMENTAL: CD: >=30 kg Participants, Vedolizumab 300 mg
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14
Time Frame: From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)
From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)
Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14
Time Frame: From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)
From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)
Ctrough,Week 14: Observed Serum Concentration at the End of a Dosing Interval at Week 14
Time Frame: At the end of a dosing interval at Week 14
At the end of a dosing interval at Week 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of UC Participants Who Achieve Clinical Response Based on Complete Mayo Score
Time Frame: Baseline (Day 1) and Week 14
Clinical response was defined as a reduction in complete Mayo score of >= 3 points and >=30 % from Baseline with an accompanying decrease in rectal bleeding sub-score of >=1 point(s) or absolute rectal bleeding sub-score of <= 1 point. Mayo score was used in to assess UC disease activity. It consisted of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale was scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranged from 0 to 12, with higher scores indicating more severe disease.
Baseline (Day 1) and Week 14
Percentage of CD Participants Who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI)
Time Frame: Baseline (Day 1) and Week 14
Clinical response was defined as >=70 points decrease from Baseline in CDAI score at Week 14. The CDAI evaluated severity of signs and symptoms of CD. Information was collected on number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory, yielding 8 items that were combined with data from a 7-day diary to obtain total CDAI score. Index values of 150 and below were associated with quiescent disease; values above that indicated active disease, values >=220 indicated moderate to severe disease, and values above 450 were seen with extremely severe disease.
Baseline (Day 1) and Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Takeda Development Center Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 26, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MLN0002-2003
  • 2017-002231-41 (EUDRACT_NUMBER)
  • U1111-1174-2041 (OTHER: WHO)
  • MLN0002-2003CTIL (REGISTRY: Israel)
  • 17/NE/0257 (REGISTRY: NRES)
  • MOH_2017-09-18_000675 (OTHER: CRS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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