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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03196427




Registration number
NCT03196427
Ethics application status
Date submitted
20/06/2017
Date registered
22/06/2017

Titles & IDs
Public title
Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
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
Secondary ID [1] 0 0
2017-002182-21
Secondary ID [2] 0 0
Vedolizumab-2005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vedolizumab

Experimental: Vedolizumab High Dose Group - Participants with UC or CD having baseline weight of greater than or equal to (\>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (\<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).

Experimental: Vedolizumab Low Dose Group - Participants with UC or CD having baseline weight of \>= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of \< 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).


Treatment: Drugs: Vedolizumab
Vedolizumab intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Baseline up to approximately 8 years
Secondary outcome [1] 0 0
Percentage of Participants With UC Meeting Clinical Response Based on Complete Mayo Score at Week 32
Timepoint [1] 0 0
Week 32
Secondary outcome [2] 0 0
Percentage of Participants With CD Meeting Clinical Response Based on 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 32
Timepoint [2] 0 0
Week 32
Secondary outcome [3] 0 0
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
Timepoint [3] 0 0
Baseline up to approximately 8 years
Secondary outcome [4] 0 0
Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 8 Years
Timepoint [4] 0 0
Baseline up to approximately 8 years
Secondary outcome [5] 0 0
Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 8 Years
Timepoint [5] 0 0
Baseline up to approximately 8 years
Secondary outcome [6] 0 0
Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Timepoint [6] 0 0
Baseline up to approximately 8 years
Secondary outcome [7] 0 0
Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Timepoint [7] 0 0
Baseline up to approximately 8 years
Secondary outcome [8] 0 0
Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 8 Years
Timepoint [8] 0 0
Baseline up to approximately 8 years
Secondary outcome [9] 0 0
Percentage of Participants Achieving Tanner Stage V
Timepoint [9] 0 0
Baseline up to approximately 8 years

Eligibility
Key inclusion criteria
1. Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003.

(Note: A participant 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.)
2. Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a >=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity Index (PCDAI) of >=15 points for participants with CD.
3. May be receiving a therapeutic dose of the following drugs:

* Oral 5-aminosalicylic acid (5-ASA) compounds.
* Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day]) provided the participant was receiving this medication during prior participation in MLN0002-2003.
* Topical (rectal) treatment with 5-ASA or corticosteroids.
* Probiotics (example, Saccharomyces boulardii).
* Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
* Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
* Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
4. The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Is female and is lactating or pregnant.
2. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
3. Has withdrawn from Study MLN0002-2003.
4. Has developed any new 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.
5. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
6. Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
7. Has other serious comorbidities that will limit his or her ability to complete the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/11/2025
Actual
Sample size
Target
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
France
State/province [8] 0 0
Ile-de-france
Country [9] 0 0
Hungary
State/province [9] 0 0
Borsod-abauj-zemplen
Country [10] 0 0
Hungary
State/province [10] 0 0
Csongrad
Country [11] 0 0
Hungary
State/province [11] 0 0
Hajdu-bihar
Country [12] 0 0
Israel
State/province [12] 0 0
Tel Aviv
Country [13] 0 0
Israel
State/province [13] 0 0
Haifa
Country [14] 0 0
Israel
State/province [14] 0 0
Jerusalem
Country [15] 0 0
Israel
State/province [15] 0 0
Petach Tiqwa
Country [16] 0 0
Poland
State/province [16] 0 0
Lodzkie
Country [17] 0 0
Poland
State/province [17] 0 0
Malopolskie
Country [18] 0 0
Poland
State/province [18] 0 0
Podkarpackie
Country [19] 0 0
Ukraine
State/province [19] 0 0
Kharkiv
Country [20] 0 0
United Kingdom
State/province [20] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Takeda Development Center Americas, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03196427