Crohn's Disease (CD)
Vedolizumab Maintenance Doses for Children and Teens With Crohn’s Disease
This Phase 3 study is investigating whether intravenous vedolizumab maintenance therapy leads to clinical remission and endoscopic response in children and teens with moderately to severely active Crohn’s disease who respond to initial vedolizumab treatment.
Registry title: A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
15 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Vedolizumab IV
- Design
- Randomized · Quadruple
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
Among pediatric participants who respond to initial intravenous vedolizumab, how well do the study’s high- and low-dose maintenance regimens support clinical remission and endoscopic response?
Participant snapshot
Who the study is looking for
- The study is looking for children and teens ages 2 through 17 with Crohn’s disease.
- Participants must weigh at least 10 kilograms at screening and enrollment.
- The study is looking for participants whose Crohn’s disease was diagnosed at least one month before screening and meets specified clinical and endoscopic activity thresholds.
- Participants must have failed, lost response to, or been unable to tolerate at least one listed standard treatment.
Participation overview
What participation may involve
All enrolled participants receive weight-based intravenous vedolizumab during induction. Those with a clinical response at Week 14 are randomly assigned to high- or low-dose maintenance vedolizumab. A blinded dose increase and one-time corticosteroid rescue may be used if response is not maintained. What participation may involve: - Receive intravenous vedolizumab on Day 1 and at Weeks 2 and 6, with the dose determined by baseline weight. - If a clinical response is present at Week 14, receive the assigned high or low maintenance dose every eight weeks through Week 46. - Complete Crohn’s disease activity assessments, endoscopic assessments, laboratory measurements, safety monitoring, and growth and development measurements. - Participants who do not maintain corticosteroid-free clinical response at Week 54 have an end-of-study or early-termination visit, a safety visit 18 weeks after their last dose, and up to two years of long-term follow-up. The main treatment and outcome period extends through Week 54. The record describes safety monitoring through Week 72 and, for some participants, up to 104 weeks of long-term follow-up after the last study-drug dose. The record specifies infusions on Day 1 and at Weeks 2 and 6, followed for Week 14 responders by infusions every eight weeks from Week 14 through Week 46. It does not provide a complete visit calendar.
Study interventions
What participants may receive or do
- Vedolizumab IV: Vedolizumab is given through an intravenous (IV) infusion. Initial doses are based on body weight and given on Day 1 and at Weeks 2 and 6. Participants with a clinical response at Week 14 are assigned to a weight-based high- or low-dose maintenance regimen given every eight weeks through Week 46.
Study design
How the comparison works
This Phase 3 treatment study gives all participants open-label vedolizumab during induction. Participants with a clinical response at Week 14 enter parallel high- or low-dose maintenance groups. Participants with a clinical response at Week 14 are assigned by chance in a 1:1 ratio to high- or low-dose maintenance groups, with assignment stratified by prior tumor necrosis factor-alpha antagonist exposure or failure and by weight group. The maintenance dose is masked from participants, care providers, investigators, and outcome assessors. The record says the participant and study doctor may learn the dose if there is an urgent medical need. The study compares two active, weight-based vedolizumab maintenance doses; the low-dose group serves as the comparison for the high-dose group.
Reported activities
Procedures and tests
- Pediatric Crohn’s Disease Activity Index assessments, which include symptoms, height velocity, hematocrit, erythrocyte sedimentation rate, and albumin.
- Endoscopic assessment using the Simple Endoscopic Score for Crohn’s Disease, including ulcers, affected surface, and intestinal narrowing.
- Blood sampling to measure vedolizumab concentrations before and after doses at multiple time points.
- Pre-dose blood testing for antibodies against vedolizumab, including neutralizing antibodies.
- Safety monitoring for adverse events, serious adverse events, and events of special interest through Week 72.
- Weight and linear-growth measurements through Week 54.
- Tanner stage assessment of physical sexual development at Week 54.
- Screening may involve confirming tuberculosis status, hepatitis B and C status, stool testing, vaccination history, and prior surveillance colonoscopy when applicable.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Crohn’s disease must be moderately to severely active and unresponsive or intolerant to the participant’s current standard care.
- Participants must weigh at least 10 kilograms at screening and enrollment.
- Crohn’s disease must have been diagnosed at least one month before screening.
- At screening, the Pediatric Crohn’s Disease Activity Index must be above 30 and the endoscopic score above 6, or at least 4 when disease is confined to the terminal ileum.
- Participants must have failed, lost response to, or been unable to tolerate at least one listed therapy; certain steroid- or nutrition-dependent participants with worsening disease during tapering may also meet this requirement.
- Participants with specified long-standing extensive, pancolitis, or left-sided colitis must have a documented negative surveillance colonoscopy within the previous 12 months.
- Childhood vaccinations must be current according to the accepted schedule in the participant’s country.
Possible reasons someone may not be able to join
- Recent investigational or approved biologic treatment is excluded within the registry’s specified timing windows.
- Active cerebral or meningeal disease, progressive multifocal leukoencephalopathy, or another listed major neurological disorder is excluded.
- A clinically significant infection within 30 days before the first study-drug dose is excluded.
- A live vaccination within 30 days before the first study-drug dose is excluded.
- Participants who currently need or are expected to need Crohn’s disease surgery during the study are excluded.
- Specified prior bowel surgeries, ostomies, an ileo-anal pouch, fixed intestinal narrowing, short bowel syndrome, or more than three small-intestine resections are excluded.
- A current diagnosis of indeterminate colitis or clinical features suggesting monogenic very early-onset inflammatory bowel disease is excluded.
- Active or latent tuberculosis shown by the specified screening tests is excluded.
- Certain hepatitis B or chronic hepatitis C results are excluded, with the registry’s stated exceptions for confirmed absence of viral material.
- An identified congenital or acquired immune deficiency, including HIV infection or organ transplantation, is excluded.
- Evidence of dysplasia or most prior malignancies is excluded, except for the specifically listed successfully treated localized cancers.
- Positive screening stool tests for ova, parasites, culture, or Clostridioides difficile are excluded.
Important unknowns
What the record does not make clear
- The registry gives the infusion schedule and several assessment time points but does not provide a complete calendar of study visits or the expected length of each visit.
- The record does not clearly state which current Crohn’s disease medicines or nutrition therapies may continue during the study.
- The registry reports timing restrictions for biologic agents and live vaccines but says other inclusion and exclusion criteria may apply; a complete medication washout list is not provided.
- A screening endoscopy and endoscopic outcomes at Weeks 14 and 54 are described, but the record does not clearly provide the complete endoscopy schedule or preparation and sedation requirements.
- The registry does not state which study-related treatments, procedures, or routine-care costs are paid by the sponsor or billed to insurance.
- The record does not report whether participants or caregivers receive compensation or reimbursement.
- The registry does not report whether transportation, lodging, meals, or other travel support is available.
- The record does not state whether any follow-up visits or assessments may be completed remotely or with a local clinician.
- The record says participants may be eligible for extension study MLN0002-3029 after Week 54, but it does not guarantee continued vedolizumab access or explain all entry conditions.
- The overall study is recruiting, but listed locations have different statuses, including recruiting, not yet recruiting, withdrawn, and terminated.
Before contacting the site
Questions for the study team
- What is the complete schedule of clinic visits, infusions, blood draws, endoscopies, and follow-up contacts?
- Which current Crohn’s disease medicines, steroids, supplements, or nutrition therapies must continue, stop, taper, or remain stable?
- How many endoscopies are required, and what bowel preparation, anesthesia, or sedation is used for children at this site?
- What happens if symptoms worsen during maintenance, and how are blinded dose escalation and one-time corticosteroid rescue decided?
- Which study-related costs are covered, and are compensation, travel, lodging, parking, or meal reimbursements available?
- What are the requirements for entering extension study MLN0002-3029, and what treatment is available after Week 54?
- Is the nearest listed site actively enrolling this participant’s age, weight, and treatment-history group?
Before changing care
Questions for your gastroenterologist
- How stable is the child’s Crohn’s disease now, and what are the medical risks of changing current treatment for screening or study participation?
- Which approved treatment alternatives remain appropriate given the child’s prior responses, intolerances, disease location, and current severity?
- How should current medicines, corticosteroids, and enteral nutrition be coordinated with the research team without interrupting necessary care?
- Are the study’s endoscopies, blood tests, growth assessments, and possible rescue corticosteroids reasonable in this child’s clinical context?
- How would the gastroenterologist and research team share results and manage worsening disease, infections, or other urgent problems?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active CD. The drug is tested and approved in adults in approximately 70 countries. Participants to be enrolled must have failed response to, lost response to, or been intolerant to at least 1 of the current standard of care (SOC) induction and maintenance therapies for CD including exclusive and/or partial enteral nutrition therapy, immunomodulators (e.g., azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), and tumor necrosis factor-alpha (TNF-α) antagonists. The study will enroll approximately 120 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as: * Participants 10 to 15 kg, Vedolizumab 150 mg * Participants \>15 to \<30 kg, Vedolizumab 200 mg * Participants ≥30 kg, Vedolizumab 300 mg At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and by weight groups. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows: * Participants ≥30 kg, Vedolizumab 300 mg (High dose) or 150 mg (Low dose) * Participants \>15 to \<30 kg, Vedolizumab 200 mg (High dose) 100 mg (Low dose) * Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) or 100 mg (Low dose) The dose will remain blinded to the participant and study doctor during the study (unless there is an urgent medical need). All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion to the high dose in their weight group based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed during Maintenance Period. This multi-center trial will be conducted worldwide. After the Week 54, participants may be eligible to continue receiving vedolizumab in extension study MLN0002-3029. Participants who do not maintain corticosteroid-free clinical response at week 54 will undergo an end-of-study (EOS) or ET visit, and a safety visit 18 weeks after the last dose of vedolizumab followed by 2 years of long term follow-up (up to 104 weeks), in addition these participants will then be eligible to enter study MLN0002-3029 for an observational LTFU period of 2 years after the last dose of study drug.
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- MLN0002-3025
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Quadruple
- Who is masked
- Participant, Care Provider, Investigator, Outcomes Assessor
- Standard age groups
- Child
Study arms
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
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.
Interventions: Drug: Vedolizumab IV
Interventions
Drug
Vedolizumab IV
Vedolizumab IV
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (6)
- The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC).Registry-derived · unreviewed
- The participants weigh ≥10 kg at the time of screening and enrollment into the study.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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)-α 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.Registry-derived · unreviewed
Exclusion criteria (19)
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- The participants has received any live vaccinations within 30 days prior to first dose.Registry-derived · unreviewed
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants with a current diagnosis of indeterminate colitis.Registry-derived · unreviewed
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease.Registry-derived · unreviewed
- 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:Registry-derived · unreviewed
- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, ORRegistry-derived · unreviewed
- A TB skin test reaction ≥5 mm.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA).Registry-derived · unreviewed
- Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks before baseline\]).Registry-derived · unreviewed
- The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.Registry-derived · unreviewed
- Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of Participants With Clinical Remission at Week 54 Based on Pediatric Crohn's Disease Activity Index (PCDAI) Score ≤10
Time frame: Week 54
Clinical remission is defined by PCDAI score ≤10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of \<10 will be consistent with inactive disease, 11 to 30 will indicate mild disease, and \>30 will indicate moderate to severe disease. A decrease of 12.5 points is taken as evidence of improvement.
Primary outcome
Percentage of Participants With Endoscopic Response at Week 54 Based on Simple Endoscopic Score for Crohn's Disease [SES-CD] Score
Time frame: Week 54
Endoscopic response is defined as at least a 50% reduction in SES-CD score from Baseline. The overall SES-CD score ranges from 0 to 56 and is the sum of 4 variables (ie, size of ulcers \[cm\], ulcerated surface, affected surface \[%\], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is the most severe case, with the sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The segmental SES-CD score is the sum of the 4 variables for each bowel segment and can range from 0 to 12, where each individual variable score ranges from 0 to 3.
Secondary outcome
Percentage of Participants with Clinical and Endoscopic Remission at Week 14 Based on Both PCDAI Score and SES-CD Score
Time frame: Week 14
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score \>1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers \[cm\], ulcerated surface, affected surface \[%\], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants with Clinical and Endoscopic Remission at Week 54 Based on Both PCDAI Score and SES-CD Score
Time frame: Week 54
Clinical and endoscopic remission is where participant achieves both clinical and endoscopic remission. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined by SES-CD score of ≤4 with at least a 2-point reduction from Baseline and no sub-score \>1. PCDAI includes child-specific item: height velocity variable as well as three laboratory parameters: HCT, ESR, albumin level. PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers \[cm\], ulcerated surface, affected surface \[%\], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants with Sustained Clinical and Endoscopic Remission at Week 54
Time frame: Week 54
Sustained clinical and endoscopic remission is where a participant achieved clinical and endoscopic remission based on PCDAI and SES-CD scores at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. Endoscopic remission is defined as ≤4 with at least a 2-point reduction from Baseline and no sub-score \>1 by SES-CD. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. The SES-CD score ranges from 0 to 56 and is the sum of 4 variables, size of ulcers \[cm\], ulcerated surface, affected surface \[%\], and presence of narrowing) across 5 bowel segments (ie, rectum, descending and sigmoid colon, transverse colon, ascending colon, and ileum), where higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants with Corticosteroid-free Remission at Week 54 Based on PCDAI Score
Time frame: Week 54
Corticosteroid-free clinical remission is where participants achieves corticosteroid-free clinical remission based on PCDAI at Week 54 and has been off corticosteroids at least 12 weeks prior to and at Week 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease.
Secondary outcome
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Time frame: Week 14
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score \>1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants with Sustained Endoscopic Remission Based on SES-CD Score
Time frame: Week 54
Sustained endoscopic remission is where participants achieves endoscopic remission based on SES-CD ≤4 with at least a 2-point reduction from Baseline and no sub-score \>1. The SES-CD evaluates 4 endoscopic variables (Size of ulcers, Ulcerated surface, Affected surface and Presence of narrowing). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the four endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Secondary outcome
Percentage of Participants with Sustained Clinical Remission at Week 14 Based on PCDAI Score
Time frame: Week 14
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Secondary outcome
Percentage of Participants with Sustained Clinical Remission at Week 54 Based on PCDAI Score
Time frame: Week 54
Sustained Clinical Remission is where participants will achieve clinical remission based on PCDAI at Weeks 14 and 54. Clinical remission is defined by PCDAI score ≤10. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Secondary outcome
Serum Trough Concentrations of Vedolizumab Over Time
Time frame: Predose and postdose at multiple time points (up to 54 weeks)
Secondary outcome
Percentage of Participants With Positive Antivedolizumab Antibodies
Time frame: Pre-dose (up to 54 weeks)
Secondary outcome
Percentage of Participants With Positive Neutralizing Antivedolizumab Antibody Titers
Time frame: Pre-dose (up to 54 weeks)
Secondary outcome
Sustained Clinical Response at Week 14 Based on PCDAI Score
Time frame: Week 14
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Secondary outcome
Sustained Clinical Response at Week 54 Based on PCDAI Score
Time frame: Week 54
Sustained clinical response is where a participant achieve clinical response based on PCDAI score ≤30 and reduction of the PCDAI by ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Secondary outcome
Percentage of Participants with Clinical Remission at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Time frame: Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical remission is defined by PCDAI score \< 10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT (adjusted for age and sex), ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Secondary outcome
Percentage of Participants with Change in Baseline in Clinical Response at Weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Time frame: Baseline, weeks 2, 6, 10, 14, 22, 30, 38, 46, and 54
Clinical Response is where participants achieves clinical response if PCDAI ≤30 with reduction in the PCDAI of ≥15 points from Baseline. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: HCT, ESR, and albumin level. The PCDAI score will range from 0 to 100, with higher scores indicating more active disease.
Secondary outcome
Percentage of Participants with at Least One Adverse Event (AE), Serious Adverse Event (SAE), and AE of special interest (AESI)
Time frame: From first dose of study drug before each dose on dosing days through the Week 72
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether it is considered related to drug. SAE is any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to congenital anomaly/birth defect and/or is important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to compound or program, for which ongoing monitoring and rapid communication by investigator. AESIs include- opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, infusion-related reactions, hypersensitivity.
Secondary outcome
Change from Baseline in Weight
Time frame: Baseline up to Week 54
Change from in Baseline in weight will be calculated as: Weight at each study visit (up to Week 54) - Weight at Baseline.
Secondary outcome
Change from Baseline in Linear Growth Z-score
Time frame: Baseline up to Week 54
Linear growth Z-score will be calculated as: Z-score = (observed value - median value of the reference population)/ standard deviation value of reference population.
Secondary outcome
Change from Baseline in Tanner Stages at Week 54
Time frame: Week 54
Tanner Stage is used to define physical measurements of sexual development based on external primary and secondary sex characteristics. Female and male participants are evaluated for breast development and genital development respectively and both genders for pubic hair distribution based on a 5-stage scale ranging from Stage I (prepubertal/preadolescent characteristics) to Stage V (mature or adult characteristics).
Recruiting locations in the United States
Phoenix Childrens Hospital
Not Yet RecruitingPhoenix, Arizona, 85016, United States
Site Contact602-933-0940apatel12@phoenixchildrens.com
Ashish Patel
Rady Childrens Hospital San Diego - PIN
Not Yet RecruitingSan Diego, California, 92123, United States
Site Contact381-688-2247yhuang815@163.com
Ying Huang
Childrens Center For Digestive Healthcare
RecruitingAtlanta, Georgia, 30342, United States
Site Contact404-257-0799bgold@gicareforkids.com
Benjamin Gold
Advocate Children's Hospital Park Ridge
RecruitingPark Ridge, Illinois, 60068, United States
Site Contact847-723-7700Ts.Gunasekaran@aah.org
Thirumazhisai S. Gunasekaran
Johns Hopkins University
Not Yet RecruitingBaltimore, Maryland, 21287, United States
Site Contact141-095-5876moliva@jhmi.edu
Maria Oliva-Hemker
Boston Children's Hospital
Not Yet RecruitingBoston, Massachusetts, 02115, United States
Site Contact617-355-2962naamah.zitomersky@childrens.harvard.edu
Naamah Zitomersky
MNGI Digestive Health, PA
RecruitingMinneapolis, Minnesota, 55413, United States
Site Contact612-813-7240Ramalingam.Arumugam@mngi.com
Ramalingam Arumugam
Mayo Clinic - PIN
Not Yet RecruitingRochester, Minnesota, 55905, United States
Site Contact507-266-0114stephens.michael@mayo.edu
Michael Stephens
Goryeb Children's Hospital
RecruitingMorristown, New Jersey, 07960, United States
Site Contact973-971-5676alycia.leiby@atlantichealth.org
Alycia Leiby
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
RecruitingNew Hyde Park, New York, 11042, United States
Site Contact516-472-3650jmarkowi2@nshs.edu
James Markowitz
Stony Brook University Medical Center
RecruitingStony Brook, New York, 11794, United States
Site Contact888-888-8888anupama.chawla@stonybrookmedicine.edu
Anupama Chawla
University Hospitals Cleveland Medical Center
Not Yet RecruitingCleveland, Ohio, 44106, United States
Site Contact216-286-0221thomas.sferra@uhhospitals.org
Thomas Sferra
Children's Hospital of Pittsburgh
Not Yet RecruitingPittsburgh, Pennsylvania, 15201, United States
Site Contact412-692-6558whitney.sunseri@chp.edu
Whitney Sunseri
Texas Children's Hospital
RecruitingHouston, Texas, 77030, United States
Site Contact832-824-1000faith.ihekweazu@bcm.edu
Faith Ihekweazu
Carilion Children's Tanglewood Center
RecruitingRoanoke, Virginia, 24018, United States
Site Contact540-985-9832jcolazagasti@carilionclinic.org
Juan Olazagasti
This study also lists 74 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Mar 3, 2021
- Primary completion
- Sep 13, 2027
- Overall completion
- Sep 13, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.