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Monoclonal Antibodies

Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg for Ulcerative Colitis

Q: At how many distinct venues is this medical trial currently being conducted?

Recruitment efforts for this trial have enlisted 72 participants, with notable locations such as Hadassah Medical Center - PPDS in Jerusalem, Monash Health at Monash Medical Centre in Clayton, and University of Alberta Hospital in Edmonton. Additionally, there are 69 other sites participating in patient recruitment.

Q: What is the current sample size of patients involved in this clinical investigation?

This research project aims to enroll 240 eligible individuals who satisfy the defined criteria. Patient enrollment is open at diverse sites, including Hadassah Medical Center - PPDS in Jerusalem, Yerushalayim and Monash Health, Monash Medical Centre in Clayton, Victoria.

Q: Are there any available positions for patients to participate in this clinical trial?

Indeed, data on clinicaltrials.gov indicates that this investigation is presently enrolling participants. The trial was first listed on May 16th, 2023 and the latest update was made on March 5th, 2024. A total of 240 individuals are sought across a network of 72 locations for enrollment in this study.

Q: What is the safety profile of Vedolizumab 150 mg for patients included in the Treatment Cohort: Participants weighing between 10 and less than or equal to 15 kg?

In the context of this Phase 3 trial, Treatment Cohort: Participants weighing between 10 and ≤15 kg receiving Vedolizumab at a dose of 150 mg is rated as a level 3 in terms of safety by our team at Power. This rating signifies that there exists some evidence backing its efficacy along with repeated data reinforcing its safety profile.

Q: Are there any previous studies that have included a Treatment Cohort with participants weighing between 10 and ≤15 kg, receiving Vedolizumab at a dose of 150 mg?

In a specific treatment group, comprising individuals weighing between 10 and 15 kg, the efficacy of Vedolizumab at a dose of 150 mg was initially investigated in 2017 at Icahn School of Medicine at Mount Sinai. Subsequently, there have been a total of 221 concluded investigations. Presently, there are ongoing active research initiatives amounting to nine studies, with several being conducted within Jerusalem, also known as Yerushalayim.

Q: Is the clinical trial open to individuals above the age of 35 for participation?

Participants eligible for this research must fall between the ages of 2 and 17. Among clinical trials, there are approximately 121 studies catering to minors under 18 and around 498 focusing on individuals older than 65 years old.

Q: What are the main goals that this clinical trial aims to achieve?

The main goal of this investigation is to assess the occurrence of at least one adverse event in participants over a period of about 2 years. Secondary objectives involve evaluating changes from baseline in social functioning, body image perception, and treatment/intervention ease using specific scales for young individuals aged 9 to 17 every 24 weeks.

Phase 3

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, every 24 weeks in this study (up to approximately 5 years)

Awards & highlights

Study Summary

"This trial is an extension of two previous studies and is looking at the long-term safety of vedolizumab in children with ulcerative colitis or Crohn's disease who participated in the earlier

Who is the study for?

This trial is for children with Ulcerative Colitis or Crohn's Disease who completed previous studies MLN0002-3024 or MLN0002-3025 and responded well without steroids. Participants must agree to use effective contraception if they are sexually active.Check my eligibility

What is being tested?

The study tests the long-term safety of Vedolizumab, a medication given through IV, in children. It extends two prior studies and continues to monitor those who previously received Vedolizumab.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of Vedolizumab may include headache, joint pain, nausea, fever, infections, and potential infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, every 24 weeks in this study (up to approximately 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, every 24 weeks in this study (up to approximately 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 24 weeks in this study (up to approximately 5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Observational Cohort: Number of Participants With Prespecified Safety Events

Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)

Secondary outcome measures

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

+5 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group II: Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group III: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing >15 to <30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group IV: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing >15 to <30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group V: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group VI: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mgExperimental Treatment1 Intervention

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Group VII: Observational Cohort: Early Terminated Participants From Parent StudiesExperimental Treatment1 Intervention

Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vedolizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,203 Previous Clinical Trials

4,177,704 Total Patients Enrolled

23 Trials studying Ulcerative Colitis

9,014 Patients Enrolled for Ulcerative Colitis

Study DirectorStudy DirectorTakeda

1,211 Previous Clinical Trials

489,032 Total Patients Enrolled

23 Trials studying Ulcerative Colitis

9,567 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct venues is this medical trial currently being conducted?

"Recruitment efforts for this trial have enlisted 72 participants, with notable locations such as Hadassah Medical Center - PPDS in Jerusalem, Monash Health at Monash Medical Centre in Clayton, and University of Alberta Hospital in Edmonton. Additionally, there are 69 other sites participating in patient recruitment."

Answered by AI

What is the current sample size of patients involved in this clinical investigation?

"This research project aims to enroll 240 eligible individuals who satisfy the defined criteria. Patient enrollment is open at diverse sites, including Hadassah Medical Center - PPDS in Jerusalem, Yerushalayim and Monash Health, Monash Medical Centre in Clayton, Victoria."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"Indeed, data on clinicaltrials.gov indicates that this investigation is presently enrolling participants. The trial was first listed on May 16th, 2023 and the latest update was made on March 5th, 2024. A total of 240 individuals are sought across a network of 72 locations for enrollment in this study."

Answered by AI

What is the safety profile of Vedolizumab 150 mg for patients included in the Treatment Cohort: Participants weighing between 10 and less than or equal to 15 kg?

"In the context of this Phase 3 trial, Treatment Cohort: Participants weighing between 10 and ≤15 kg receiving Vedolizumab at a dose of 150 mg is rated as a level 3 in terms of safety by our team at Power. This rating signifies that there exists some evidence backing its efficacy along with repeated data reinforcing its safety profile."

Answered by AI

Are there any previous studies that have included a Treatment Cohort with participants weighing between 10 and ≤15 kg, receiving Vedolizumab at a dose of 150 mg?

"In a specific treatment group, comprising individuals weighing between 10 and 15 kg, the efficacy of Vedolizumab at a dose of 150 mg was initially investigated in 2017 at Icahn School of Medicine at Mount Sinai. Subsequently, there have been a total of 221 concluded investigations. Presently, there are ongoing active research initiatives amounting to nine studies, with several being conducted within Jerusalem, also known as Yerushalayim."

Answered by AI

Is the clinical trial open to individuals above the age of 35 for participation?

"Participants eligible for this research must fall between the ages of 2 and 17. Among clinical trials, there are approximately 121 studies catering to minors under 18 and around 498 focusing on individuals older than 65 years old."

Answered by AI

What are the main goals that this clinical trial aims to achieve?

"The main goal of this investigation is to assess the occurrence of at least one adverse event in participants over a period of about 2 years. Secondary objectives involve evaluating changes from baseline in social functioning, body image perception, and treatment/intervention ease using specific scales for young individuals aged 9 to 17 every 24 weeks."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

2023. "A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442567.

All > Ulcerative Colitis > Colitis