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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 9 November 2020
Main ID:  EUCTR2017-002182-21-PL
Date of registration: 13/10/2017
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe, Ltd.
Public title: An extension study to investigate how safe Vedolizumab is in child patients with Ulcerative Colitis or Crohn’s Disease
Scientific title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease. (Long-term Safety With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble Zoom
Date of first enrolment: 17/01/2018
Target sample size: 80
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002182-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: AT WEEK 40 THE BLINDING WILL BE LIFTED. If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Vedolizumab to be tested at doses of 300mg, 200mg, 150 mg and 100mg Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Canada France Germany Hungary Israel Netherlands Poland
Ukraine United Kingdom United States
Contacts
Name: Takeda Study Registration Call Cent   
Address:  Uknown Uknown Uknown United States
Telephone: +1877825-3327
Email: medicalinformation@tpna.com
Affiliation:  Takeda
Name: Takeda Study Registration Call Cent   
Address:  Uknown Uknown Uknown United States
Telephone: +1877825-3327
Email: medicalinformation@tpna.com
Affiliation:  Takeda
Key inclusion & exclusion criteria
Inclusion criteria:
-The subject is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of their randomization in Study MLN0002-2003. (Note: A subject remains eligible to participate in this study after they reach 18 years of age if they continue to meet the inclusion criteria and do not meet any exclusion criteria.)
-The subject completed Study MLN0002-2003 and , at Week 22, achieved clinical response as defined by a reduction of partial Mayo score =2 points and =25% from Baseline, or reduction of the PUCAI of =20 points from baseline for subjects with UC; or a reduction of CDAI as defined by a =70 point decrease from Baseline or a decrease of PCDAI of =15 points for subject with CD.
-The subject may be receiving a therapeutic dose of the following drugs:
– Oral 5-aminosalicylic (5-ASA) compounds.
– Oral corticosteroid therapy (prednisone or equivalent steroid at a dose =50 mg/day)
– Topical (rectal) treatment with 5-ASA or corticosteroid.
– Probiotics (eg, Saccharomyces boulardii).
– Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
– Antibiotics used for treatment of CD (eg, ciprofloxacin, metronidazole).
– Azathioprine, 6-mercaptopurine, or methotrexate provided the subject was receiving this medication during prior participation in Study MLN0002-2003.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
-The subject is female and is lactating or pregnant.
-The subject has hypersensitivity or allergies to vedolizumab or any of its excipients.
-The subject has withdrawn from Study MLN0002-2003.
-The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, 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 subject safety.
-The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
-The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
-The subject has other serious comorbidities that will limit their ability to complete the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative Colitis or Crohn’s Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Intervention(s)

Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Entyvio
Product Name: Vedolizumab
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: - To determine the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.
Primary end point(s): The primary endpoint for this study is percentage of subjects with treatment-emergent adverse events (TEAEs).

Secondary Objective: - To evaluate the efficacy of long-term vedolizumab IV in pediatric subject with UC or CD.
-To determine the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel disease (IBD)-related events (hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD.
-To examine the effect of long-term vedolizumab IV treatment on health-related quality-of- life measurements in pediatric subjects with UC or CD.
-To determine the effect of long-term vedolizumab IV treatment on patterns of growth and development in pediatric subjects with UC or CD.
Timepoint(s) of evaluation of this end point: Monitored throughout the study
Secondary Outcome(s)
Secondary end point(s): The secondary endpoints for this study are:
- Percentage of UC subjects who, at Week 32, achieve and maintain clinical response based on complete Mayo score, as defined by a continued reduction in complete Mayo score of =3 points from the baseline (at initiation of MLN0002-2003) and continued decrease in rectal bleeding subscore of =1 point from baseline, or absolute rectal bleeding subscore of =1 point at Week 32.
-Precentage of CD subjects who, at Week 32, achieve and maintain clinical response as defined by a 50% reduction in SES-CD score on endoscopy compared to the baseline endoscopy (at initiation of MLN0002-2003); and continued reduction in CDAI that is a =70 point decrease from the baseline CDAI score at the initiation of MLN0002-2003.
- Time to major IBD-related events (hospitalizations, surgeries, or procedures).
- Changes from Baseline in IMPACT-III (where translations are available) total and subscale scores at Week 24 and every 24 weeks, thereafter.
- Height velocity at Week 48 and every 48 weeks, thereafter.
- Change from Baseline in height, weight, and body mass index (BMI) at Week 24 and every 24 weeks, thereafter.
- Percentage of subjects achieving Tanner stage V at or before age 16 years (females) or 17 years (males).
Timepoint(s) of evaluation of this end point: Monitored throughout the study
Secondary ID(s)
009125
2017-002182-21-GB
Vedolizumab-2005
Source(s) of Monetary Support
Takeda Development Centre Europe, Ltd.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/11/2017
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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