Vedolizumab Subcutaneous Long-term Open-label Extension Study in Pediatric Subjects

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Takeda Development Center Americas Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

15 Oct 2025 → ongoing

Decision date (initial)

2025-10-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Takeda Development Center Americas Inc.

External identifiers

EU CT number

2023-508804-39-00

ClinicalTrials.gov

NCT06405087

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

The primary objective of the treatment cohort is to evaluate the safety profile of long-term vedolizumab SC treatment in pediatric subjects with UC or CD

Secondary objectives 2

1. The effect of long-term vedolizumab SC treatment on time to major inflammatory bowel disease (IBD)-related events (eg, hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD
2. Quality of life in subjects aged 9 to 17 years who were treated with vedolizumab SC using the IMPACT-III questionnaire

Conditions and MedDRA coding

Ulcerative Colitis or Crohn’s Disease

Study design 2 periods

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-000645-PIP01-09

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 01. In the opinion of the investigator, the subject or subject’s legally authorized representative, subject’s parent, or legal guardian (adult caregiver) is capable of understanding and complying with protocol requirements
2. 02. The subject, subject’s legally authorized representative or adult caregiver signs and dates a written treatment cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations
3. 03. The subject is male or female with UC or CD and aged <18 years. (Note: subjects who reach adult age [18 years in most jurisdictions/regions] during the study should be considered to transition to commercial drug if available in their country, especially if transition to an adult care setting is required by local regulation)
4. 04. The subject completed Week 34 of Study VedolizumabSC-3003 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 subjects with UC is defined as a reduction of partial Mayo score of ≥2 points and ≥25% from baseline (from VedolizumabSC-3003), 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 ≤1 point. Clinical response for subjects with CD is defined as a PCDAI ≤30 with a reduction in the PCDAI of ≥15 points from baseline (from VedolizumabSC-3003)
5. 05. A male subject who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (eg, condom with spermicide) from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after the last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception
6. 06. A female subject of childbearing potential who is sexually active with a non-sterilized male partner agrees to use a highly effective method of contraception from signing of subject/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after the last dose
7. Observational Cohort: 01. The subject, subject’s legally authorized representative or adult caregiver signs and dates a written observational cohort subject/parental informed consent and/or pediatric assent form and any required privacy authorization before the initiation of any study procedures, as required per local regulations.
8. Observational Cohort: 02. The subject has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 but was not eligible to enroll in the treatment cohort of this study

Exclusion criteria 6

1. 01. The subject is female and is lactating or pregnant
2. 02. The subject has hypersensitivity or allergies to vedolizumab or any of its excipients
3. 03. The subject currently requires major surgical intervention for UC or CD (eg, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study
4. 04. The subject developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, 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 subject safety.
5. 05. The subject has other serious comorbidities that will limit their ability to complete the study
6. 06. The subject is unable to comply with all study assessments

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Observational Cohort: Incidence of safety events (SAEs, serious infections, malignancies, PML, bowel surgery, and delay in growth or pubertal development).
2. Treatment Cohort: The primary endpoints for this study are the incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (ie, infections including opportunistic infection, such as PML; liver injury; malignancies; injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions)

Secondary endpoints 2

1. Treatment Cohort: Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures) from Day 1 of Study VedolizumabSC-3004.
2. Changes from baseline of Study VedolizumabSC-3003 in IMPACT-III total and subscale scores for subjects aged 9 to 17 years

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Takeda Development Center Americas Inc.

Sponsor organisation

Takeda Development Center Americas Inc.

Address

500 Kendall Street

City

Cambridge

Postcode

02142-1108

Country

United States

Scientific contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Ninfa Candela MD

Public contact point

Organisation

Takeda Development Center Americas Inc.

Contact name

Takeda

Third parties 10

Locations

10 EU/EEA countries · 26 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 123 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications