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Recruiting Phase 3

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

NCT05442567 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Phase 3
Started
2023-05-16
Last updated
2026-05-07

Condition(s) studied

Ulcerative ColitisCrohn's Disease

Investigational drug(s) / intervention(s)

Vedolizumab IV →No Intervention

Vedolizumab IV: Vedolizumab IV infusion

No Intervention: Participants will not receive any intervention in the Observational Cohort.

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Treatment Cohort: Number of Participants With at Least One Adverse Event (AE) — From first dose of study drug up to approximately 5 years
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have causal relationship with this treatment. AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to drug.
  • Observational Cohort: Number of Participants With Prespecified Safety Events — Up to approximately 2 years
    Prespecified safety events will include serious infections, malignancies, progressive multifocal leukoencephalopathy (PML), concerns about growth and pubertal development, and bowel surgery.

Trial sites (98)

FacilityCityRegionStatus
University of South Alabama (USA) Physicians Group Mobile Alabama Not Yet Recruiting
Phoenix Childrens Hospital - Thomas Rd - PIN Phoenix Arizona Recruiting
Cedars Sinai Medical Center - 127 San Vicente Blvd Los Angeles California Withdrawn
Rady Children's Hospital - San Diego - PIN San Diego California Not Yet Recruiting
University of California San Francisco San Francisco California Withdrawn
I.H.S Health LLC-Kissimmee-445 W Oak St Kissimmee Florida Withdrawn
Childrens Center For Digestive Healthcare Atlanta Georgia Not Yet Recruiting
Advocate Children's Hospital - Park Ridge - PIN Park Ridge Illinois Recruiting
Riley Hospital For Children - PIN Indianapolis Indiana Withdrawn
Johns Hopkins University Baltimore Maryland Withdrawn
Boston Children's Hospital - PIN Boston Massachusetts Withdrawn
MNGI Digestive Health PA-Plymouth Minneapolis Minnesota Terminated
Mayo Clinic - PIN Rochester Minnesota Terminated
Goryeb Children's Hospital Morristown New Jersey Terminated
Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN New Hyde Park New York Withdrawn
University of Rochester Medical Center - PPDS Rochester New York Withdrawn
Stony Brook University Medical Center Stony Brook New York Withdrawn
University Hospitals Cleveland Medical Center - 11100 Euclid Ave Cleveland Ohio Not Yet Recruiting
UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN Pittsburgh Pennsylvania Withdrawn
Hasbro Children's Hospital - PIN Providence Rhode Island Withdrawn
Texas Children's Hospital - Baylor - PIN Houston Texas Not Yet Recruiting
Carilion Children's Tanglewood Center Roanoke Virginia Recruiting
Children's Hospital at Westmead Westmead New South Wales Recruiting
Queensland Childrens Hospital South Brisbane Queensland Recruiting
Monash Health, Monash Medical Centre Clayton Victoria Not Yet Recruiting
Royal Children's Hospital Melbourne - PIN Parkville Victoria Recruiting
UZ Antwerpen - PIN Edegem Antwerpen Recruiting
UZ Brussel - PIN Jette Brussels Capital Recruiting
UZ Leuven Leuven Vlaams Brabant Recruiting
University of Alberta Hospital Edmonton Alberta Withdrawn
British Columbia Children's Hospital - 4480 Oak St Vancouver British Columbia Withdrawn
London Health Sciences Centre -800 Commissioners Rd E London Ontario Terminated
Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec Withdrawn
Beijing Children's Hospital, Capital Medical University - PIN Beijing Beijing Municipality Not Yet Recruiting
Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus Zhengzhou Henan Recruiting
Hunan Children's Hospital Changsha Hunan Recruiting
Children's Hospital of Fudan University Shanghai Shanghai Municipality Recruiting
The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus Hangzhou Zhejiang Recruiting
Children's Hospital Zagreb Zagreb City of Zagreb Recruiting
University Hospital Center Zagreb Zagreb City of Zagreb Withdrawn

+ 58 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05442567 on ClinicalTrials.gov ↗ ← All trials in Japan