RECRUITINGPhase 3INTERVENTIONAL
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
About This Trial
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 May Be Eligible (Plain English)
Main Who May Qualify:
For Treatment Cohort:
1. 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.
2. 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 willing to sign a consent form 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.
3. 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 willing to sign a consent form and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.
For Observational Cohort:
1\. 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 Who Should NOT Join This Trial:
For Treatment Cohort only:
1. 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Main Inclusion Criteria:
For Treatment Cohort:
1. 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.
2. 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.
3. 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:
1\. 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:
1. 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.
2. 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.
3. The participant has other serious comorbidities that will limit their ability to complete the study.
4. The participant is unable to comply with all study assessments.
5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
6. The participant is lactating or pregnant.
Treatments Being Tested
DRUG
Vedolizumab IV
Vedolizumab IV infusion
OTHER
No Intervention
Participants will not receive any intervention in the Observational Cohort.
Locations (20)
Phoenix Childrens Hospital -1919 E Thompson Rd
Phoenix, Arizona, United States
Rady Childrens Hospital San Diego - PIN
San Diego, California, United States
Childrens Center For Digestive Healthcare
Atlanta, Georgia, United States
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
New Hyde Park, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Carilion Children's Tanglewood Center
Roanoke, Virginia, United States
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, Australia
UZ Antwerpen
Edegem, Antwerpen, Belgium
Universitair Ziekenhuis Brussel - PIN
Jette, Brussels Capital, Belgium