RECRUITING

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

Description

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.

Conditions

Ulcerative ColitisCrohn's Disease
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Related Conditions:

Ulcerative ColitisCrohn's Disease

Study Overview

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Study Details

Study overview

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.

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Childrens Hospital -1919 E Thompson Rd, Phoenix, Arizona, United States, 85016-7710

San Diego

Rady Childrens Hospital San Diego - PIN, San Diego, California, United States, 92123-4223

Atlanta

Childrens Center For Digestive Healthcare, Atlanta, Georgia, United States, 30342

Park Ridge

Advocate Children's Hospital Park Ridge, Park Ridge, Illinois, United States, 60068

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21287-0005

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115-5724

Minneapolis

MNGI Digestive Health PA-Plymouth, Minneapolis, Minnesota, United States, 55413

Rochester

Mayo Clinic - PIN, Rochester, Minnesota, United States, 55905-0001

Morristown

Goryeb Children's Hospital, Morristown, New Jersey, United States, 07960-6136

New Hyde Park

The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS, New Hyde Park, New York, United States, 11042-2062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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 barrier method of contraception (e.g., 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 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 informed consent throughout the duration of the study and 18 weeks after the last dose.
  • 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.
  • 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.

Ages Eligible for Study

2 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Takeda,

Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

2031-08-15