A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Recruiting · NCT05442567 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
No InterventionVedolizumab IV
What this trial is about
The study is an extension of two parent studies (MLN0002-3024 \[NCT04779307\] and MLN0002-3025 \[NCT04779320\]). Participants must have participated in one of the previous studies. The purpose of this study is to collect the long-term safety of vedolizumab in children with UC or CD.
Who can take part
Age range
2 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- For Treatment Cohort:
- The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and 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 participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30.
- A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
- For Observational Cohort:
- \. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.
- Main
Exclusion criteria
- For Treatment Cohort only:
- The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- The participant has developed any new unstable or uncontrolled cardiovascular, heart failure moderate to severe (New York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (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 participant safety.
- The participant has other serious comorbidities that will limit their ability to complete the study.
- The participant is unable to comply with all study assessments.
- The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
- The participant is lactating or pregnant.
Where it is running
60 locations listed across 17 US states.
- University of South Alabama (USA) Physicians Group - Mobile, Alabama, United States
- University of South Alabama (USA) Physicians Group - Mobile, Alabama, United States
- Phoenix Childrens Hospital - Thomas Rd - PIN - Phoenix, Arizona, United States
- Phoenix Childrens Hospital - Thomas Rd - PIN - Phoenix, Arizona, United States
- Cedars Sinai Medical Center - 127 San Vicente Blvd - Los Angeles, California, United States
- Cedars Sinai Medical Center - 127 San Vicente Blvd - Los Angeles, California, United States
- Rady Children's Hospital - San Diego - PIN - San Diego, California, United States
- Rady Children's Hospital - San Diego - PIN - San Diego, California, United States
- University of California San Francisco - San Francisco, California, United States
- University of California San Francisco - San Francisco, California, United States
- I.H.S Health LLC-Kissimmee-445 W Oak St - Kissimmee, Florida, United States
- I.H.S Health LLC-Kissimmee-445 W Oak St - Kissimmee, Florida, United States
- Childrens Center For Digestive Healthcare - Atlanta, Georgia, United States
- Childrens Center For Digestive Healthcare - Atlanta, Georgia, United States
- Advocate Children's Hospital - Park Ridge - PIN - Park Ridge, Illinois, United States
- Advocate Children's Hospital - Park Ridge - PIN - Park Ridge, Illinois, United States
- Riley Hospital For Children - PIN - Indianapolis, Indiana, United States
- Riley Hospital For Children - PIN - Indianapolis, Indiana, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Boston Children's Hospital - PIN - Boston, Massachusetts, United States
- Boston Children's Hospital - PIN - Boston, Massachusetts, United States
- MNGI Digestive Health PA-Plymouth - Minneapolis, Minnesota, United States
- MNGI Digestive Health PA-Plymouth - Minneapolis, Minnesota, United States
- Mayo Clinic - PIN - Rochester, Minnesota, United States
- Mayo Clinic - PIN - Rochester, Minnesota, United States
- Goryeb Children's Hospital - Morristown, New Jersey, United States
- Goryeb Children's Hospital - Morristown, New Jersey, United States
- Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN - New Hyde Park, New York, United States
- Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN - New Hyde Park, New York, United States
- University of Rochester Medical Center - PPDS - Rochester, New York, United States
- University of Rochester Medical Center - PPDS - Rochester, New York, United States
- Stony Brook University Medical Center - Stony Brook, New York, United States
- Stony Brook University Medical Center - Stony Brook, New York, United States
- University Hospitals Cleveland Medical Center - 11100 Euclid Ave - Cleveland, Ohio, United States
- University Hospitals Cleveland Medical Center - 11100 Euclid Ave - Cleveland, Ohio, United States
- UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN - Pittsburgh, Pennsylvania, United States
- UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN - Pittsburgh, Pennsylvania, United States
- Hasbro Children's Hospital - PIN - Providence, Rhode Island, United States
- Hasbro Children's Hospital - PIN - Providence, Rhode Island, United States
- Texas Children's Hospital - Baylor - PIN - Houston, Texas, United States
- Texas Children's Hospital - Baylor - PIN - Houston, Texas, United States
- Carilion Children's Tanglewood Center - Roanoke, Virginia, United States
- Carilion Children's Tanglewood Center - Roanoke, Virginia, United States
- Children's Hospital Agia Sofia - Athens, Greece
- Children's Hospital Agia Sofia - Athens, Greece
- Hospital Sant Joan de Deu - PIN - Barcelona, Spain
- Hospital Sant Joan de Deu - PIN - Barcelona, Spain
- Soroka University Medical Centre - Beersheba, Israel
- Soroka University Medical Centre - Beersheba, Israel
- Narodny ustav detskych chorob - Bratislava, Slovakia
- Narodny ustav detskych chorob - Bratislava, Slovakia
- Clinexpert Obuda Egeszsegcentruma - Budapest, Hungary
- Semmelweis Egyetem, Pulmonologiai Klinika - Budapest, Hungary
- Clinexpert Obuda Egeszsegcentruma - Budapest, Hungary
- Semmelweis Egyetem, Pulmonologiai Klinika - Budapest, Hungary
- Rambam Health Care Campus PPDS - Haifa, Israel
- Carmel Medical Center - Haifa, Israel
- Rambam Health Care Campus PPDS - Haifa, Israel
- Carmel Medical Center - Haifa, Israel
Showing 60 of 196 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →