A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease

• Register: EUCTR
• Last refreshed on: 9 December 2024
• Main ID: EUCTR2021-000630-34-HR
• Date of registration: 05/01/2023
• Prospective Registration: No
• Primary sponsor: Takeda Development Center Americas, Inc.
• Public title: A study to evaluate the long term safety of Vedolizumab in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease
• Scientific title: A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn’s Disease
• Date of first enrolment: 27/12/2022
• Target sample size: 93
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000630-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Different doses of IMP are used in treatment arms Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, China, Croatia, Czech Republic, Czechia, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Director, Clinical Operations
• Affiliation: Takeda Development Center Americas, Inc.

• Name: Director, Clinical Operations
• Affiliation: Takeda Development Center Americas, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. In the opinion of the investigator, the subject, parent, or legal guardian is capable of understanding and complying with protocol requirements.
2. The subject, parent, or legal guardian signs and dates a written, informed consent form and any required privacy authorization before the initiation of any study procedures.
3. The subject is male or female with UC or CD and aged <18 years. (Note: Subjects who reach adult age [18 years of age 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. The subject has completed Study MLN0002-3024 or Study MLN0002-3025 and has achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of =2 points and =25% from baseline for subjects with UC; or a reduction of PCDAI of =15 points for subjects with CD from baseline of the parent study.
5. A male subject who is sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (eg, condom with or without spermicide) from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male subject should also be advised to use a highly effective method of contraception.
6. A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and 18 weeks after the last dose.
Are the trial subjects under 18? yes
Number of subjects for this age range: 93
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. The subject is female and is lactating or pregnant.
2. The subject has hypersensitivity or allergies to any of the vedolizumab excipients.
3. 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. The subject has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal, 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. The subject has other serious comorbidities that will limit their ability to complete the study.
6. The subject is unable to comply with all study assessments.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active Ulcerative Colitis (UC) or Crohn's disease (CD)

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: ENTYVIO
Product Name: Vedolizumab
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Other descriptive name: MLN0002
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 100-300

Primary Outcome(s)

Secondary Objective: • To evaluate the effect of long-term vedolizumab IV treatment on time to major inflammatory bowel disease (IBD)-related events (eg, hospitalizations, surgeries, and procedures) in pediatric subjects with UC or CD.
• To evaluate quality of life in subjects aged 9 to 17 years who were treated with vedolizumab IV using the IMPACT-III questionnaire.

Timepoint(s) of evaluation of this end point: Once every 16 weeks until Week 48, thereafter once every 24 weeks.

Main Objective: The primary objective of this study is to evaluate the safety profile of long-term vedolizumab IV treatment in pediatric subjects with UC or CD.

Primary end point(s): The primary endpoint for this study is adverse events (AEs).

Secondary Outcome(s)

Secondary end point(s): • Time to major IBD-related events (eg, hospitalizations, surgeries, or procedures).
• Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured every 24 weeks.

Timepoint(s) of evaluation of this end point: Time to major IBD-related events - through-out duration of the study.
Changes from baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III total and subscale scores for subjects aged 9 to 17 years as measured - every 24 weeks.

Secondary ID(s)

009125

2021-000630-34-HU

MLN0002-3029

Source(s) of Monetary Support

Takeda Development Center Americas, Inc.

Ethics review

Status: Approved
Approval date: 24/11/2022
Contact: