Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
NCT ID: NCT03138655
Last Updated: 2020-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2017-11-08
2020-05-26
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Vedolizumab
Vedolizumab IV infusion.
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.
Vedolizumab
Vedolizumab IV infusion.
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.
Vedolizumab
Vedolizumab IV infusion.
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.
Vedolizumab
Vedolizumab IV infusion.
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.
Vedolizumab
Vedolizumab IV infusion.
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.
Vedolizumab
Vedolizumab IV infusion.
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.
Vedolizumab
Vedolizumab IV infusion.
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.
Vedolizumab
Vedolizumab IV infusion.
Interventions
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Vedolizumab
Vedolizumab IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
17 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Nemours Children's Clinic
Wilmington, Delaware, United States
Nemours Childrens Specialty Care - Jacksonville
Jacksonville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Children's Center for Digestive Healthcare
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University School of Medicine - Indianapolis
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Northwell Health
Lake Success, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
The Children's Hospital at Montefiore
The Bronx, New York, United States
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Childrens Medical Center of Dallas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Children's Specialty Group - Medical Center Location
Norfolk, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hopital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Alberta Children's Hospital
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre University Hospital
London, Ontario, Canada
Toronto Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, Canada
Hopital Jeanne de Flandre
Lille, Hauts-de-France, France
Hopital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hopital Necker-Enfants Malades
Paris, Île-de-France Region, France
Hopital Robert Debre
Paris, Île-de-France Region, France
Universitatsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Ludwig-Maximillians-Universitat Munchen
München, Bavaria, Germany
Universitatsmedizin Rostock - Kinder und Jugendklinik
Rostock, Mecklenburg-Vorpommern, Germany
Universitatsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony, Germany
BAZ Megyei Korhaz es Egyetemi Oktatokorhaz
Miskolc, Borsod-Abauj Zemplen county, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Csongrád megye, Hungary
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet
Sopron, Győr-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Soroka University Medical Center
Beersheba, Beersheba, Israel
Schneider Children's Medical Center of Israel
Petach Tikvah, Petah Tiqwa, Israel
Assaf Harofeh Medical Center
Ẕerifin, Rehoboth, Israel
The Edmond and Lily Safra Children's Hospital - Sheba Medical Center
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus - Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Radboud Universitair Medisch Centrum
Nijmegen, GA, Netherlands
Emma Kinderziekenhuis AMC
Amsterdam, North Holland, Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Warszawski Uniwersytet Medyczny
Warsaw, Masovian Voivodeship, Poland
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, Podkarpackie Voivodeship, Poland
Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku
Bialystok, Podlaskie Voivodeship, Poland
Copernicus Podmiot Leczniczy
Gdansk, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE
Szczecin, West Pomeranian Voivodeship, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic
Lodz, Łódź Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
National Scientific Center of Radiological Medicine of NAMS of Ukraine
Kyiv, KIEV CITY, Ukraine
Kharkiv Regional Clinical Children's Hospital
Kharkiv, , Ukraine
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, England, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Barts and The London NHS Trust
London, England, United Kingdom
King's College Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, England, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, England, United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, England, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-002231-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1174-2041
Identifier Type: OTHER
Identifier Source: secondary_id
MLN0002-2003CTIL
Identifier Type: REGISTRY
Identifier Source: secondary_id
17/NE/0257
Identifier Type: REGISTRY
Identifier Source: secondary_id
MOH_2017-09-18_000675
Identifier Type: OTHER
Identifier Source: secondary_id
MLN0002-2003
Identifier Type: -
Identifier Source: org_study_id