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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04779320




Registration number
NCT04779320
Ethics application status
Date submitted
1/03/2021
Date registered
3/03/2021

Titles & IDs
Public title
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Scientific title
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
Secondary ID [1] 0 0
2020-004301-31
Secondary ID [2] 0 0
MLN0002-3025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease (CD) 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

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

Experimental: Induction Period: 10 to 15 kg, Vedolizumab 150 mg - Vedolizumab 150 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.

Experimental: Induction Period: >15 to <30 kg, Vedolizumab 200 mg - Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of \>15 to \<30 kg will be included in this arm group.

Experimental: Induction Period: =30 kg, Vedolizumab 300 mg - Vedolizumab 300 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of =30 kg will be included in this arm group.

Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 150 mg - Vedolizumab 150 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.

Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 100 mg - Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.

Experimental: Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg - Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.

Experimental: Maintenance Period: >15 to <30 kg Vedolizumab 100 mg - Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.

Experimental: Maintenance Period: =30 kg, Vedolizumab 300 mg - Vedolizumab 300 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of =30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.

Experimental: Maintenance Period: =30 kg: Vedolizumab 150 mg - Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of =30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.


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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score =10
Timepoint [1] 0 0
Week 54
Primary outcome [2] 0 0
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
Timepoint [2] 0 0
Week 54
Secondary outcome [1] 0 0
Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
Timepoint [1] 0 0
Week 14
Secondary outcome [2] 0 0
Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
Timepoint [2] 0 0
Week 54
Secondary outcome [3] 0 0
Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
Timepoint [3] 0 0
Week 54
Secondary outcome [4] 0 0
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
Timepoint [4] 0 0
Week 54
Secondary outcome [5] 0 0
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Timepoint [6] 0 0
Week 54
Secondary outcome [7] 0 0
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
Timepoint [7] 0 0
Week 14
Secondary outcome [8] 0 0
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
Timepoint [8] 0 0
Week 54
Secondary outcome [9] 0 0
Serum Trough Concentrations of Vedolizumab Over Time
Timepoint [9] 0 0
Predose and postdose at multiple time points (up to 54 weeks)
Secondary outcome [10] 0 0
Percentage of Participants With Positive Antivedolizumab Antibodies
Timepoint [10] 0 0
Pre-dose (up to 54 weeks)
Secondary outcome [11] 0 0
Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
Timepoint [11] 0 0
Pre-dose (up to 54 weeks)
Secondary outcome [12] 0 0
Sustained Clinical Response at Week 14 Based on PCDAI Score
Timepoint [12] 0 0
Week 14
Secondary outcome [13] 0 0
Sustained Clinical Response at Week 54 Based on PCDAI Score
Timepoint [13] 0 0
Week 54
Secondary outcome [14] 0 0
Percentage of Participants with Clinical Remission at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Timepoint [14] 0 0
Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Secondary outcome [15] 0 0
Percentage of Participants with Change in Baseline in Clinical Response at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Timepoint [15] 0 0
Baseline, weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Secondary outcome [16] 0 0
Percentage of Participants with at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AE of special interest (AESI)
Timepoint [16] 0 0
From first dose of study drug before each dose on dosing days through the Week 72
Secondary outcome [17] 0 0
Change from Baseline in Weight
Timepoint [17] 0 0
Baseline up to Week 54
Secondary outcome [18] 0 0
Change from Baseline in Linear Growth Z-score
Timepoint [18] 0 0
Baseline up to Week 54
Secondary outcome [19] 0 0
Change from Baseline in Tanner Stages at Week 54
Timepoint [19] 0 0
Week 54

Eligibility
Key inclusion criteria
Main

1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).
2. The participants weigh =10 kg at the time of screening and enrollment into the study.
3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease (SES-CD) >6 (or an SES-CD =4 if disease is confined to terminal ileum) at screening endoscopy.
4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumor necrosis factor (TNF)-a antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
5. Participants with extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

Main
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
2. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug.
4. The participants has received any live vaccinations within 30 days prior to first dose.
5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
6. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections.
7. Participants with a current diagnosis of indeterminate colitis.
8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.
9. 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 mm.
10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen [HBsAg]-negative and hepatitis B antibody-positive) may, however, be included.

Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.
11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody [HCVAb] and HCV RNA).

Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks before baseline]).
12. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
13. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
14. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
15. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

Other inclusion/exclusion criteria may apply.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
30/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
120
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
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
State/province [5] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Minnesota
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New Jersey
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New York
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Ohio
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Pennsylvania
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Rhode Island
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United States of America
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Texas
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United States of America
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Virginia
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Belgium
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Antwerpen
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Belgium
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Brussels
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Belgium
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Vlaams Brabant
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Henan
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China
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Shanghai
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China
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Zhejiang
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Croatia
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Grad Zagreb
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Croatia
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Split
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Czechia
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Praha, Hlavni Mesto
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Czechia
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Ostrava
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Greece
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Attiki
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Athens
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Greece
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Thessaloniki
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Hungary
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Borsod-Abauj-Zemplen
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Hungary
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Csongrad
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HaMerkaz
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Israel
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Yerushalayim
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Israel
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Veneto
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Hukuoka
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Japan
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Kumamoto
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Japan
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Tokyo
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Korea, Republic of
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Daegu Gwang'yeogsi
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Korea, Republic of
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Incheon Gwang'yeogsi
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Lithuania
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Kauno Apskritis
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Lithuania
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Vilniaus Apskritis
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Poland
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Dolnoslaskie
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Lodzkie
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Malopolskie
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Mazowieckie
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Podkarpackie
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Poland
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Pomorskie
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Slaskie
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Poland
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Zachodniopomorskie
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Poland
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Lodz
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Spain
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Barcelona
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Spain
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Valencia
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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United Kingdom
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London, City Of
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United Kingdom
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South Glamorgan
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United Kingdom
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West Midlands
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United Kingdom
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London
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United Kingdom
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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
Address 0 0
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
medinfoUS@takeda.com
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/NCT04779320