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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05442567




Registration number
NCT05442567
Ethics application status
Date submitted
30/06/2022
Date registered
5/07/2022

Titles & IDs
Public title
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Scientific title
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
Secondary ID [1] 0 0
2021-000630-34
Secondary ID [2] 0 0
MLN0002-3029
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 IV
Other interventions - No Intervention

Experimental: Treatment Cohort: Participants 10 to =15 kg, Vedolizumab 150 mg - Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to =15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Experimental: Treatment Cohort: Participants 10 to =15 kg, Vedolizumab 100 mg - Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to =15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg - Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg - Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Experimental: Treatment Cohort: Participants =30 kg, Vedolizumab 300 mg - Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing =30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Experimental: Treatment Cohort: Participants =30 kg, Vedolizumab 150 mg - Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing =30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Other: Observational Cohort: Early Terminated Participants From Parent Studies - Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.


Treatment: Drugs: Vedolizumab IV
Vedolizumab IV infusion

Other interventions: No Intervention
Participants will not receive any intervention in the Observational Cohort.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)
Timepoint [1] 0 0
From first dose of study drug up to approximately 5 years
Primary outcome [2] 0 0
Observational Cohort: Number of Participants With Prespecified Safety Events
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Total Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Timepoint [2] 0 0
Baseline, every 24 weeks in this study (up to approximately 5 years)
Secondary outcome [3] 0 0
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Timepoint [3] 0 0
Baseline, every 24 weeks in this study (up to approximately 5 years)
Secondary outcome [4] 0 0
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Systemic Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Timepoint [4] 0 0
Baseline, every 24 weeks in this study (up to approximately 5 years)
Secondary outcome [5] 0 0
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Social Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Timepoint [5] 0 0
Baseline, every 24 weeks in this study (up to approximately 5 years)
Secondary outcome [6] 0 0
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Timepoint [6] 0 0
Baseline, every 24 weeks in this study (up to approximately 5 years)
Secondary outcome [7] 0 0
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Timepoint [7] 0 0
Baseline, every 24 weeks in this study (up to approximately 5 years)
Secondary outcome [8] 0 0
Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Timepoint [8] 0 0
Baseline, every 24 weeks in this study (up to approximately 5 years)

Eligibility
Key inclusion criteria
Main

For Treatment Cohort:

1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of =2 points and =25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of =15 points for participants with CD and with total PCDAI =30.
2. A male participant who is sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (e.g., condom with or without spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and 18 weeks after the last dose.

For Observational Cohort:

1. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.

Main
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Treatment Cohort only:

1. The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
2. The participant 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.
3. The participant has other serious comorbidities that will limit their ability to complete the study.
4. The participant is unable to comply with all study assessments.
5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
6. The participant is lactating or pregnant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2031
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Queensland Childrens Hospital - South Brisbane
Recruitment hospital [3] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Royal Children's Hospital Melbourne - PIN - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Belgium
State/province [14] 0 0
Antwerpen
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Vlaams Brabant
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
China
State/province [20] 0 0
Beijing
Country [21] 0 0
China
State/province [21] 0 0
Henan
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Zhejiang
Country [24] 0 0
Croatia
State/province [24] 0 0
Grad Zagreb
Country [25] 0 0
Greece
State/province [25] 0 0
Attiki
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Greece
State/province [27] 0 0
Thessaloniki
Country [28] 0 0
Hungary
State/province [28] 0 0
Borsod-Abauj-Zemplen
Country [29] 0 0
Hungary
State/province [29] 0 0
Budapest
Country [30] 0 0
Israel
State/province [30] 0 0
HaMerkaz
Country [31] 0 0
Israel
State/province [31] 0 0
Yerushalayim
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Israel
State/province [33] 0 0
Jerusalem
Country [34] 0 0
Israel
State/province [34] 0 0
Tel-Aviv
Country [35] 0 0
Italy
State/province [35] 0 0
Campania
Country [36] 0 0
Italy
State/province [36] 0 0
Emilia-Romagna
Country [37] 0 0
Italy
State/province [37] 0 0
Lazio
Country [38] 0 0
Italy
State/province [38] 0 0
Lombardia
Country [39] 0 0
Italy
State/province [39] 0 0
Veneto
Country [40] 0 0
Japan
State/province [40] 0 0
Hukuoka
Country [41] 0 0
Japan
State/province [41] 0 0
Kumamoto
Country [42] 0 0
Japan
State/province [42] 0 0
Tokyo
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Daegu Gwang'yeogsi
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Incheon Gwang'yeogsi
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
Country [46] 0 0
Poland
State/province [46] 0 0
Lodzkie
Country [47] 0 0
Poland
State/province [47] 0 0
Malopolskie
Country [48] 0 0
Poland
State/province [48] 0 0
Mazowieckie
Country [49] 0 0
Poland
State/province [49] 0 0
Podkarpackie
Country [50] 0 0
Poland
State/province [50] 0 0
Slaskie
Country [51] 0 0
Poland
State/province [51] 0 0
Zachodniopomorskie
Country [52] 0 0
Poland
State/province [52] 0 0
Lodz
Country [53] 0 0
Slovakia
State/province [53] 0 0
Bratislava
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London, City Of
Country [55] 0 0
United Kingdom
State/province [55] 0 0
South Glamorgan
Country [56] 0 0
United Kingdom
State/province [56] 0 0
West Midlands
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

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
Takeda Contact
Address 0 0
Country 0 0
Phone 0 0
+1-877-825-3327
Fax 0 0
Email 0 0
[email protected]
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/NCT05442567