Crohn's Disease · Ulcerative Colitis
Long-Term Vedolizumab Study in Children With Ulcerative Colitis or Crohn’s Disease
This extension study examines long-term safety and other outcomes in children and teenagers from a prior vedolizumab study, with eligible responders continuing subcutaneous vedolizumab and other participants receiving observational follow-up.
Registry title: A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
14 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Vedolizumab SC or No Intervention
- Design
- Randomized
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
What medical problems occur during long-term subcutaneous vedolizumab treatment in pediatric ulcerative colitis or Crohn’s disease, and how are inflammatory bowel disease events and quality of life affected over time?
Participant snapshot
Who the study is looking for
- The study is looking for children and teenagers ages 2 through 17 with ulcerative colitis or Crohn’s disease.
- All participants must have received at least one dose of vedolizumab in the parent study, NCT06100289.
- The treatment cohort is for participants who completed Week 34 of the parent study, met its specified clinical-response threshold, and were corticosteroid-free during Weeks 30 through 34.
- The observational cohort is for participants who left the parent study early or completed its Week 34 visit but could not enter this study’s treatment cohort.
Participation overview
What participation may involve
Treatment-cohort participants continue their parent-study vedolizumab dose and frequency using one of two injection devices. Observational-cohort participants receive no study intervention and are followed after their last parent-study dose. What participation may involve: - Treatment participants receive 108-milligram subcutaneous vedolizumab by autoinjector pen or prefilled syringe with a needle safety device. - The study monitors adverse events, serious adverse events, and specified safety events. - Participants ages 9 through 17 in the treatment cohort complete the 35-question IMPACT-III quality-of-life questionnaire at baseline and every 24 weeks through Week 120. - The treatment cohort is assessed for major inflammatory bowel disease events, including hospitalization, surgery, and procedures. - Treatment participants have a safety follow-up visit 18 weeks after their last study-drug dose. The registry describes participation as up to two years, while treatment-arm dosing may continue through Week 120 and safety follow-up through Week 138; the study team should clarify the expected timeline. The registry says participants visit the study clinic several times and identifies an 18-week post-treatment safety visit, but it does not give a complete visit schedule.
Study interventions
What participants may receive or do
- Vedolizumab SC: Participants in the treatment cohort continue a 108-milligram vedolizumab injection under the skin using either an autoinjector pen or a prefilled syringe with a needle safety device. The registry reports dosing every two weeks for participants weighing at least 30 kilograms and every four weeks for those weighing 10 to under 30 kilograms.
- No Intervention: Participants in the observational cohort receive no study intervention and are followed after their last vedolizumab dose in the parent study.
Study design
How the comparison works
This Phase 3 extension study has a treatment cohort that continues vedolizumab and an observational cohort that receives no study intervention. Treatment participants are assigned to one of two injection-device presentations. Treatment-cohort participants are randomized equally, in a 1-to-1 ratio, between an autoinjector pen and a prefilled syringe with a needle safety device. The study is open-label, meaning the registry reports no masking. The treatment arms compare two ways of delivering vedolizumab; the observational cohort receives no study intervention.
Reported activities
Procedures and tests
- Subcutaneous vedolizumab injections using an autoinjector pen or a prefilled syringe with a needle safety device
- Monitoring for adverse events, serious adverse events, infections, liver injury, malignancies, injection reactions, anaphylaxis, and hypersensitivity reactions
- Monitoring in the observational cohort for serious infections, malignancies, progressive multifocal leukoencephalopathy, growth and pubertal-development concerns, and bowel surgery
- The 35-question IMPACT-III quality-of-life questionnaire for treatment participants ages 9 through 17
- An 18-week safety follow-up visit after the final study-drug dose for treatment-cohort participants
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
- For the treatment cohort, the participant must have completed Week 34 of the parent study, met the specified clinical-response definition, and used no corticosteroids during Weeks 30 through 34.
- For ulcerative colitis, the parent-study response must meet all parts of the registry’s partial Mayo score definition.
- For Crohn’s disease, the parent-study response requires a Pediatric Crohn’s Disease Activity Index of 30 or less and a decrease of at least 15 points from baseline.
- For the observational cohort, the participant must have received at least one vedolizumab dose in the parent study and either left that study early or completed its Week 34 visit without entering this study’s treatment cohort.
- The registry age range is 2 through 17 years.
Possible reasons someone may not be able to join
- The treatment cohort excludes participants with hypersensitivity or allergies to vedolizumab or any of its ingredients.
- The treatment cohort excludes participants who currently need, or are expected to need during the study, major surgery for ulcerative colitis or Crohn’s disease.
Important unknowns
What the record does not make clear
- The registry says there will be several clinic visits and identifies an 18-week safety follow-up visit, but it does not provide the complete number, timing, or length of visits.
- The detailed description says participation is up to two years, but treatment-arm descriptions allow dosing through Week 120 and primary safety outcomes extend through Week 138.
- The registry does not explain which non-study ulcerative colitis or Crohn’s disease treatments may continue during this extension study.
- Treatment-cohort participants must have been corticosteroid-free during the final four weeks of the parent study, but other washout requirements are not reported.
- The registry does not describe rescue treatment if ulcerative colitis or Crohn’s disease worsens.
- The registry does not state whether endoscopy is required during screening or follow-up.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not report whether participants or families receive compensation.
- The registry does not report reimbursement or support for transportation, lodging, meals, or caregiver travel.
- The registry does not say whether any visits or assessments can be completed remotely.
- Treatment may stop when pediatric vedolizumab becomes commercially available or another access program becomes available, but access after the study is not otherwise explained.
- The study is recruiting overall, but listed sites have different statuses, and the registry does not confirm that each cohort is open at every site.
Before contacting the site
Questions for the study team
- What is the complete schedule and expected length of clinic visits for each cohort?
- How should families interpret the stated two-year participation period alongside dosing through Week 120 and safety follow-up through Week 138?
- Which current medicines can continue, and what rescue treatment is available if the disease worsens?
- Which examinations, blood tests, stool tests, imaging, or endoscopies are required and how often?
- Which study-related costs are covered, and are compensation or travel support available?
- Is the relevant cohort recruiting at the nearest site, and can any follow-up be completed remotely or locally?
- What happens to vedolizumab access after study treatment ends?
Before changing care
Questions for your gastroenterologist
- Would continuing the parent-study vedolizumab dose and frequency fit the current treatment plan and disease status?
- Which current medicines should remain unchanged while the study team confirms its background-treatment rules?
- What approved treatment alternatives should we compare with this extension study for the child’s current clinical situation?
- How should the study’s monitored risks, including serious infections, liver injury, malignancies, injection reactions, and hypersensitivity, be considered in this child’s medical context?
- How would you coordinate disease monitoring and treatment decisions with the research team if symptoms changed?
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
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.
The drug being tested in this study is Vedolizumab SC. Vedolizumab SC is being tested to treat pediatric participants with moderate to severe active UC or CD. This study will look at the long-term safety profile in pediatric participants who take vedolizumab SC. The study will enroll approximately 70 participants. This extension study consists of a treatment cohort and an observational cohort. Participants will continue receiving the same dose and frequency of vedolizumab SC that was received at the last dose of the parent study VedolizumabSC-3003 (NCT06100289). For the Treatment cohort participants will be randomized (1:1) to receive vedolizumab in either a prefilled syringe (PFS) as part of an autoinjector pen (PFS+AI) or a PFS with a needle safety device (PFS+NSD): * Treatment Cohort: Vedolizumab 108 milligram (mg) PFS+AI * Treatment Cohort: Vedolizumab 108 mg PFS+NSD This multi-center trial will be conducted globally. The overall time to participate in this study is up to 2 years from the first dose in the study. Participants in the treatment cohort will have a follow-up safety visit of 18 weeks after their last dose of study drug. Participants who will not be eligible for the treatment cohort will be enrolled in the observational cohort and will be followed for approximately 2 years after the last dose of vedolizumab SC received during Study VedolizumabSC-3003 (NCT06100289).
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- VedolizumabSC-3004
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child
Study arms
Experimental
Treatment Cohort: Vedolizumab 108 mg PFS+AI
Vedolizumab 108 mg, PFS+AI, subcutaneously, once every two weeks (Q2W) to the participants weighing greater than or equal to (\>=) 30 kg and once every four weeks (Q4W) to the participants weighing \>=10 to less than (\<) 30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.
Interventions: Drug: Vedolizumab SC
Experimental
Treatment Cohort: Vedolizumab 108 mg PFS+NSD
Vedolizumab 108 mg, PFS+NSD, subcutaneously, Q2W to the participants weighing \>=30 kg and Q4W to the participants weighing \>=10 to \<30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.
Interventions: Drug: Vedolizumab SC
Other
Observational Cohort: Early Terminated Participants From Parent Study
Participants who receive any dose of vedolizumab SC during the parent study VedolizumabSC-3003 (NCT06100289) and are not eligible for the treatment cohort of this extension study (that is, participants who early terminated from parent study VedolizumabSC-3003 \[NCT06100289\] or did not achieve clinical response in the parent study or who received corticosteroids in the last 4 weeks of the parent study) will only be observed in the observational cohort of this study and will not receive any dose of the vedolizumab SC in this cohort.
Interventions: Other: No Intervention
Interventions
Drug
Vedolizumab SC
Vedolizumab subcutaneous injection.
Other
No Intervention
As this is an observational cohort, no intervention will be administered.
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (1)
- 1\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.Registry-derived · unreviewed
Exclusion criteria (2)
- Has hypersensitivity or allergies to vedolizumab or any of its excipients.Registry-derived · unreviewed
- The participant 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.Registry-derived · unreviewed
Other criteria (1)
- Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of \>=2 points and \>= 25 percentage (%) from baseline (from VedolizumabSC-3003 \[NCT06100289\]), including a \>=1-point decrease in the Mayo stool frequency subscore and a \>=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (\<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) \<=30 with a reduction in the PCDAI of \>=15 points from baseline (from VedolizumabSC-3003 \[NCT06100289\]).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
Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
An Adverse event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening.
Primary outcome
Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs)
Time frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
AESI is defined as infections, including opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions.
Primary outcome
Observational Cohort: Number of Participants With Prespecified Safety Events
Time frame: Up to Week 86
Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.
Secondary outcome
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
Time frame: Up to Week 120
Time to major IBD related events is defined as time to first occurrence of any among the 3 IBD related events such as: hospitalizations, surgeries, and procedures.
Secondary outcome
Treatment Cohort: Change from Baseline in IMPACT-III Scores
Time frame: Baseline, every 24 weeks in this study (up to Week 120)
IMPACT-III questionnaire will be administered to participants aged 9 to 17 years. The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert subscale score ranging from 1 to 5 for all answers. The outcome total score ranges from 35 to 175, with higher scores suggesting better quality of life. Baseline refers to the Baseline of study VedolizumabSC-3003 (NCT06100289).
Recruiting locations in the United States
Phoenix Childrens Hospital
Not Yet RecruitingPhoenix, Arizona, 85016, United States
Site Contactbpasternak@phoenixchildrens.com
Brad Pasternak
Loma Linda University
Not Yet RecruitingLoma Linda, California, 92350, United States
Site Contactkparashette@llu.edu
Kaylan Parashette
Children's Hospital of Orange County
Not Yet RecruitingOrange, California, 92868, United States
Site Contact714-509-4099kgrant@choc.org
Kenneth Grant
Stanford Children's Health
Not Yet RecruitingPalo Alto, California, 94304, United States
Site Contactjonathan.moses@uhhospitals.org
Jonathan Moses
Advocate Children's Hospital Park Ridge
Not Yet RecruitingPark Ridge, Illinois, 60068, United States
Site Contactkiran.gorla@aah.org
Kiranmai Gorla
Childrens Hospital of Michigan
Not Yet RecruitingDetroit, Michigan, 48201, United States
Site Contact248-739-6054dass1r@cmich.edu
Renee Dass
Atlantic Health - Morristown Medical Center
Not Yet RecruitingMorristown, New Jersey, 07960, United States
Site Contactalycia.leiby@atlantichealth.org
Alycia Leiby
New York Presbyterian Hospital
Not Yet RecruitingNew York, New York, 10029, United States
Site Contactals9047@med.cornell.edu
Aliza Solomon
Cleveland Clinic
Not Yet RecruitingCleveland, Ohio, 44195, United States
Site Contactkuroswski_j@ccf.org
Jacob Kuroswski
University Children's Clinic
Not Yet RecruitingCleveland, Ohio, 44106, United States
Site Contactthomas.sferra@uhhospitals.org
Thomas Sferra
The University of Oklahoma Health Sciences Center
RecruitingOklahoma City, Oklahoma, 73104, United States
Site ContactSirish-Palle@ouhsc.edu
Sirish Palle
Penn State Health Milton South Hershey Medical Center
Not Yet RecruitingHershey, Pennsylvania, 17033, United States
Site Contactsqg5835@psu.edu
Stefany Garrity
Medical University of South Carolina
Not Yet RecruitingCharleston, South Carolina, 29425, United States
Site Contact843-876-0444suppa@musc.edu
Carmine Suppa
Multicare Health System Institute for Research and Innovation
Not Yet RecruitingTacoma, Washington, 98405, United States
Site Contact253-792-6630ruvarier@multicare.org
Raghu Varier
This study also lists 40 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- May 8, 2024
- Primary completion
- Aug 12, 2030
- Overall completion
- Aug 12, 2030
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.