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Ulcerative ColitisPhase 2NCT03138655

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

A Phase 2 study testing Vedolizumab in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 88 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Ulcerative Colitis, Crohn's Disease
What is being tested?
Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
88 sitesin 11 countries
Study dates
8 Nov 2017to 26 May 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants weighs >=10 kg at the time of randomization.
  • 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.
  • 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.
  • 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.
  • 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.
  • The participant's vaccinations are up to date.
Show all 31Show fewer
  • 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).
  • The participant may be receiving a therapeutic dose of the following drugs:
  • Oral 5-aminosalicylic acid (5-ASA) compounds, providing the dose has been stable for the 2 weeks prior to first dose of study drug.
  • 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.
  • Probiotics (example, Saccharomyces boulardii), provided the dose has been stable for the 2 weeks prior to first dose of study drug.
  • Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
  • 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.
  • Azathioprine or 6-MP, provided the dose has been stable for the 8 weeks prior to first dose of study drug.
  • Methotrexate (MTX), provided the dose has been stable for the 8 weeks prior to first dose of study drug.

Who cannot join

  • Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, or AMG 181) or MAdCAM-1 antagonists, or rituximab.
  • Has had prior exposure to vedolizumab.
  • Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
  • Requires surgical intervention for UC or CD, or is anticipated to require surgical intervention for UC or CD during this study.
  • 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.
  • 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.
Show all 23Show fewer
  • 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.
  • Clinically significant current or recent history (within 1 year prior to enrollment) of alcohol dependence or illicit drug use.
  • 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.
  • Has evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
  • Has ileostomy, colostomy, ileo-anal pouch, or known fixed symptomatic stenosis of the intestine.
  • Has extensive colonic resection, example, subtotal or total colectomy.
  • Has a history or evidence of adenomatous colonic polyps that have not been removed.
  • Has a history or evidence of colonic mucosal dysplasia.
  • 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.
  • Has any identified congenital or acquired immunodeficiency (example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
  • 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.
  • 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.
  • Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
  • Has history of lupus.
  • 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.

Trial locations and contacts

88 sites in 11 countries.

88 sites in 11 countries

United States27 sites

  • Children's Center for Digestive Healthcare

    Atlanta, Georgia, 30342

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60614

  • University Hospitals Rainbow Babies & Children's Hospital

    Cleveland, Ohio, 44106

  • Childrens Medical Center of Dallas

    Dallas, Texas, 75235

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106-3322

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Indiana University School of Medicine - Indianapolis

    Indianapolis, Indiana, 46202

  • Nemours Childrens Specialty Care - Jacksonville

    Jacksonville, Florida, 32207

  • Northwell Health

    Lake Success, New York, 11042

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10031

  • Children's Specialty Group - Medical Center Location

    Norfolk, Virginia, 23507

  • Children's Hospital of Orange County

    Orange, California, 92868

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905-0001

  • University of Utah

    Salt Lake City, Utah, 84113

  • University of California San Francisco

    San Francisco, California, 94143-0135

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • The Children's Hospital at Montefiore

    The Bronx, New York, 10467

  • Nemours Children's Clinic

    Wilmington, Delaware, 19803

Other trials in United States

Canada10 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

  • University of Alberta

    Edmonton, Alberta, T6G 1C9

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • McMaster Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • London Health Sciences Centre University Hospital

    London, Ontario, N6A 5W9

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • McGill University Health Centre Glen Site

    Montreal, Quebec, H4A 3J1

  • Toronto Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's and Women's Health Centre of British Columbia

    Vancouver, British Columbia, V6H 3V4

  • Children's Hospital of Winnipeg

    Winnipeg, Manitoba, R3A 1S1

Other trials in Canada

United Kingdom10 sites

  • Birmingham Women's and Children's NHS Foundation Trust

    Birmingham, England, B4 6NH

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 0QQ

  • NHS Greater Glasgow and Clyde

    Glasgow, Scotland, G51 4TF

  • Barts and The London NHS Trust

    London, England, E1 1BB

  • King's College Hospital

    London, England, SE5 9RS

  • Great Ormond Street Hospital for Children NHS Trust

    London, England, WC1N 3JH

  • Central Manchester University Hospitals NHS Foundation Trust

    Manchester, England, M13 9WL

  • Nottingham University Hospitals NHS Trust

    Nottingham, England, NG7 2UH

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, England, OX3 9DU

  • Sheffield Children's NHS Foundation Trust

    Sheffield, England, S10 2TH

Other trials in United Kingdom

Poland9 sites

  • Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-274

  • Copernicus Podmiot Leczniczy

    Gdansk, Pomeranian Voivodeship, 80-803

  • Uniwersytecki Szpital Dzieciecy w Krakowie

    Krakow, Lesser Poland Voivodeship, 30-663

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic

    Lodz, Łódź Voivodeship, 91-738

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, Łódź Voivodeship, 93-338

  • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

    Rzeszów, Podkarpackie Voivodeship, 35-302

  • Samodzielny Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej ZDROJE

    Szczecin, West Pomeranian Voivodeship, 70-780

  • Warszawski Uniwersytet Medyczny

    Warsaw, Masovian Voivodeship, 01-184

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship, 50-369

Other trials in Poland

Israel8 sites

  • Soroka University Medical Center

    Beersheba, Beersheba, 8410101

  • Rambam Health Care Campus - Rambam Medical Center

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Schneider Children's Medical Center of Israel

    Petach Tikvah, Petah Tiqwa, 4920235

  • The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

    Ramat Gan, Tel Aviv, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Harofeh Medical Center

    Tsrifin, Rehoboth, 7030000

Other trials in Israel

Germany5 sites

  • Universitatsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, Saxony, 04103

  • Ludwig-Maximillians-Universitat Munchen

    München, Bavaria, 80337

  • Universitatsmedizin Rostock - Kinder und Jugendklinik

    Rostock, Mecklenburg-Vorpommern, 18057

  • Universitatsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032

  • BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

    Miskolc, Borsod-Abauj Zemplen county, 3526

  • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

    Sopron, Győr-Moson-Sopron, 9400

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Belgium4 sites

  • Hopital Universitaire des Enfants Reine Fabiola

    Brussels, Brussels Capital, 1020

  • Universitair Ziekenhuis Brussel

    Brussels, Brussels Capital, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Leuven

    Leuven, Flemish Brabant, 3000

Other trials in Belgium

France4 sites

  • Hopital Jeanne de Flandre

    Lille, Hauts-de-France, 59037

  • Hopital de la Timone

    Marseille, Provence-Alpes-Côte d'Azur Region, 13385

  • Hopital Necker-Enfants Malades

    Paris, Île-de-France Region, 75015

  • Hopital Robert Debre

    Paris, Île-de-France Region, 75935

Other trials in France

Netherlands4 sites

  • Emma Kinderziekenhuis AMC

    Amsterdam, North Holland, 1105AZ

  • Radboud Universitair Medisch Centrum

    Nijmegen, GA, 6525

  • Erasmus University Medical Center

    Rotterdam, South Holland, 3015 GJ

  • Isala Klinieken

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Ukraine2 sites

  • Kharkiv Regional Clinical Children's Hospital

    Kharkiv, 61093

  • National Scientific Center of Radiological Medicine of NAMS of Ukraine

    Kyiv, KIEV CITY, 03115

Other trials in Ukraine

About this study

Official title: 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.

Read the 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.

Being tested
Vedolizumab
Keywords
Drug therapy
Medical subject headings
Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VedolizumabDrug

    Also called MLN0002, ENTYVIO, KYNTELES

    Vedolizumab IV infusion.

Study groups in NCT03138655
Study groupRoleWhat they receive
UC: <30 kg Participants, Vedolizumab 100 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab
UC: <30 kg Participants, Vedolizumab 200 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab
CD: <30 kg Participants, Vedolizumab 100 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab
CD: <30 kg Participants, Vedolizumab 200 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab
UC: >=30 kg Participants, Vedolizumab 150 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab
UC: >=30 kg Participants, Vedolizumab 300 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab
CD: >=30 kg Participants, Vedolizumab 150 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab
CD: >=30 kg Participants, Vedolizumab 300 mgExperimentalParticipants 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.
Receives: Drug: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14

    Measured: From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)

  2. Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14

    Measured: From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)

  3. Ctrough,Week 14: Observed Serum Concentration at the End of a Dosing Interval at Week 14

    Measured: At the end of a dosing interval at Week 14

Secondary outcomes (2)

  1. Percentage of UC Participants Who Achieve Clinical Response Based on Complete Mayo Score

    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.

    Measured: Baseline (Day 1) and Week 14

  2. Percentage of CD Participants Who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI)

    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.

    Measured: Baseline (Day 1) and Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study start8 Nov 2017
  3. Primary completion31 Mar 2020
  4. Study completion26 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03138655
Sponsor's protocol ID
MLN0002-2003
Other IDs
2017-002231-41, U1111-1174-2041, MLN0002-2003CTIL, 17/NE/0257, MOH_2017-09-18_000675, 2017
Status last verified
Nov 2020
First submitted
19 Apr 2017
Last updated
21 Dec 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vedolizumab in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 88 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Canada, United Kingdom, Poland, Israel and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03138655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.

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