Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT ID: NCT03196427

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2025-07-17

Brief Summary

The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

Detailed Description

The drug being tested in this study is called Vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active UC or CD.

This study will look at the long-term safety profile in participants who take vedolizumab IV. Participants will continue receiving the same dose assigned from the parent study MLN0002-2003 [NCT03138655], which will remain blinded until week 40.

The dosing regimen selected for the long-term study is intended to maintain clinical response at the lowest possible exposure.

At the discretion of the investigator, participants receiving the low dose (150 or 100 milligram [mg]) of vedolizumab IV may be escalated to the high dose (300 or 200 mg) if the participants demonstrate disease worsening at 2 consecutive visits (scheduled or unscheduled).

Participants who experience continued disease worsening during the study despite being administered vedolizumab 300 or 200 mg every 8 weeks (Q8W) will be discontinued from the study.

Study duration will be until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug, the participant withdraws from the study, or the sponsor decides to close the study (up to approximately 8 years).

Conditions

Ulcerative Colitis; Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vedolizumab High Dose Group

Participants with UC or CD having baseline weight of greater than or equal to (\>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (\<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab intravenous infusion

Vedolizumab Low Dose Group

Participants with UC or CD having baseline weight of \>= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of \< 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).

Group Type: EXPERIMENTAL

Vedolizumab

Intervention Type: DRUG

Vedolizumab intravenous infusion

Interventions

Vedolizumab

Vedolizumab intravenous infusion

Intervention Type: DRUG

Other Intervention Names

MLN0002; ENTYVIO; KYNTELES

Eligibility Criteria

Inclusion Criteria

1. Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003.

2. Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as defined by a reduction of partial Mayo score of >=2 points and >=25% from Baseline, or a reduction of the Paediatric Ulcerative Colitis Activity Index (PUCAI) of >=20 points from baseline for participants with UC; or a reduction of the CDAI as defined by a >=70-point decrease from Baseline or a decrease of Pediatric Crohn's Disease Activity Index (PCDAI) of >=15 points for participants with CD.

3. May be receiving a therapeutic dose of the following drugs:

• Oral 5-aminosalicylic acid (5-ASA) compounds.
• Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than or equal to [<=] 50 milligram per day [mg/day]) provided the participant was receiving this medication during prior participation in MLN0002-2003.
• Topical (rectal) treatment with 5-ASA or corticosteroids.
• Probiotics (example, Saccharomyces boulardii).
• Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
• Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
• Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.

Exclusion Criteria

1. Is female and is lactating or pregnant.

2. Has hypersensitivity or allergies to vedolizumab or any of its excipients.

3. Has withdrawn from Study MLN0002-2003.

4. 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.

5. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.

6. Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.

7. Has other serious comorbidities that will limit his or her ability to complete the study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

University of California San Francisco

San Francisco, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Nemours Childrens Specialty Care - Jacksonville

Jacksonville, Florida, United States

Children's Center for Digestive Healthcare

Atlanta, Georgia, United States

Columbia University Medical Center

New York, New York, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Hopital Necker-Enfants Malades

Paris, Île-de-France Region, France

BAZ Megyei Korhaz es Egyetemi Oktatokorhaz

Miskolc, Borsod-Abauj Zemplen county, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrád megye, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, Hungary

The Edmond and Lily Safra Children's Hospital - Sheba Medical Center

Ramat Gan, Tel Aviv, Israel

Carmel Medical Center

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Schneider Children's Medical Center of Israel

Petach Tiqwa, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

Rzeszów, Podkarpackie Voivodeship, Poland

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Osrodek Pediatryczny im Marii Konopnic

Lodz, Łódź Voivodeship, Poland

Kharkiv Regional Clinical Children's Hospital

Kharkiv, , Ukraine

Barts and The London NHS Trust

London, England, United Kingdom

Countries

United States; France; Hungary; Israel; Poland; Ukraine; United Kingdom

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b60394db2bf003ab4a220?idFilter=%5B%22vedolizumab-2005%22%5D

Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Other Identifiers

2017-002182-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1176-5741

Identifier Type: OTHER

Identifier Source: secondary_id

17/NE/0258

Identifier Type: REGISTRY

Identifier Source: secondary_id

MOH_2017-09-18_000649

Identifier Type: OTHER

Identifier Source: secondary_id

2023-507766-35-00

Identifier Type: CTIS

Identifier Source: secondary_id

Vedolizumab-2005

Identifier Type: -

Identifier Source: org_study_id