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

NCT05442567 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: MLN0002-30292023-509046-36-00jRCT2071230036
• Study Type: interventional
• Target: 240
• Locations: 18 countries
• Sites: 98

Brief 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.

Conditions

Ulcerative Colitis; Crohn's Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)

  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.

  From first dose of study drug up to approximately 5 years

• Observational Cohort: Number of Participants With Prespecified Safety Events

  Prespecified safety events will include serious infections, malignancies, progressive multifocal leukoencephalopathy (PML), concerns about growth and pubertal development, and bowel surgery.

  Up to approximately 2 years

Secondary Outcomes (8)

• Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events

  Up to approximately 5 years

• Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Total Score for Participants Aged 9 to 17 Years for Every 24 Weeks

  Baseline, every 24 weeks in this study (up to approximately 5 years)

• Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Bowel Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

  Baseline, every 24 weeks in this study (up to approximately 5 years)

• Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Systemic Symptom Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

  Baseline, every 24 weeks in this study (up to approximately 5 years)

• Treatment Cohort: Change From Baseline of Studies MLN0002-3024 (UC) or MLN0002-3025 (CD) in IMPACT-III Social Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks

  Baseline, every 24 weeks in this study (up to approximately 5 years)

Study Arms (7)

Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg

EXPERIMENTAL

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Drug: Vedolizumab IV

Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg

EXPERIMENTAL

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing 10 to ≤15 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Drug: Vedolizumab IV

Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg

EXPERIMENTAL

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 200 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Drug: Vedolizumab IV

Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg

EXPERIMENTAL

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing \>15 to \<30 kg will receive vedolizumab 100 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Drug: Vedolizumab IV

Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg

EXPERIMENTAL

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 300 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Drug: Vedolizumab IV

Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg

EXPERIMENTAL

Eligible participants from studies MLN0002-3024 or MLN0002-3025 weighing ≥30 kg will receive vedolizumab 150 mg, IV infusion, Q8W, (same as their Week 46 dose in parent study) in this study for up to approximately 5 years.

Drug: Vedolizumab IV

Observational Cohort: Early Terminated Participants From Parent Studies

OTHER

Participants will have assessment visits at Day 1 and Weeks 8, 34, 60, and 86 as part of a long-term follow-up period to assess prespecified safety events of interest and to monitor growth and pubertal development for approximately 2 years after their last dose of study drug in parent study.

Other: No Intervention

Interventions

Vedolizumab IV DRUG

Vedolizumab IV infusion

Also known as: MLN0002, ENTYVIO, KYNTELES

Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg; Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg; Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg; Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg; Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg; Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg

No Intervention OTHER

Participants will not receive any intervention in the Observational Cohort.

Observational Cohort: Early Terminated Participants From Parent Studies

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (98)

University of South Alabama (USA) Physicians Group

Mobile, Alabama, 36604, United States

NOT YET RECRUITING

Phoenix Childrens Hospital - Thomas Rd - PIN

Phoenix, Arizona, 85016, United States

RECRUITING

Cedars Sinai Medical Center - 127 San Vicente Blvd

Los Angeles, California, 90048, United States

WITHDRAWN

Rady Children's Hospital - San Diego - PIN

San Diego, California, 92123, United States

NOT YET RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

WITHDRAWN

I.H.S Health LLC-Kissimmee-445 W Oak St

Kissimmee, Florida, 34741, United States

WITHDRAWN

Childrens Center For Digestive Healthcare

Atlanta, Georgia, 30342, United States

NOT YET RECRUITING

Advocate Children's Hospital - Park Ridge - PIN

Park Ridge, Illinois, 60068, United States

RECRUITING

Riley Hospital For Children - PIN

Indianapolis, Indiana, 46202, United States

WITHDRAWN

Johns Hopkins University

Baltimore, Maryland, 21287, United States

WITHDRAWN

Boston Children's Hospital - PIN

Boston, Massachusetts, 02215, United States

WITHDRAWN

MNGI Digestive Health PA-Plymouth

Minneapolis, Minnesota, 55413, United States

TERMINATED

Mayo Clinic - PIN

Rochester, Minnesota, 55905, United States

TERMINATED

Goryeb Children's Hospital

Morristown, New Jersey, 07960, United States

TERMINATED

Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN

New Hyde Park, New York, 11042, United States

WITHDRAWN

University of Rochester Medical Center - PPDS

Rochester, New York, 14642, United States

WITHDRAWN

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

WITHDRAWN

University Hospitals Cleveland Medical Center - 11100 Euclid Ave

Cleveland, Ohio, 44106, United States

NOT YET RECRUITING

UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN

Pittsburgh, Pennsylvania, 15201, United States

WITHDRAWN

Hasbro Children's Hospital - PIN

Providence, Rhode Island, 02903, United States

WITHDRAWN

Texas Children's Hospital - Baylor - PIN

Houston, Texas, 77030, United States

NOT YET RECRUITING

Carilion Children's Tanglewood Center

Roanoke, Virginia, 24018, United States

RECRUITING

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

RECRUITING

Queensland Childrens Hospital

South Brisbane, Queensland, 4101, Australia

RECRUITING

Monash Health, Monash Medical Centre

Clayton, Victoria, 3168, Australia

NOT YET RECRUITING

Royal Children's Hospital Melbourne - PIN

Parkville, Victoria, 3052, Australia

RECRUITING

UZ Antwerpen - PIN

Edegem, Antwerpen, 2650, Belgium

RECRUITING

UZ Brussel - PIN

Jette, Brussels Capital, 1090, Belgium

RECRUITING

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

WITHDRAWN

British Columbia Children's Hospital - 4480 Oak St

Vancouver, British Columbia, V6H 3N1, Canada

WITHDRAWN

London Health Sciences Centre -800 Commissioners Rd E

London, Ontario, N6A 5W9, Canada

TERMINATED

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

WITHDRAWN

Beijing Children's Hospital, Capital Medical University - PIN

Beijing, Beijing Municipality, 100045, China

NOT YET RECRUITING

Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus

Zhengzhou, Henan, 450018, China

RECRUITING

Hunan Children's Hospital

Changsha, Hunan, 410007, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus

Hangzhou, Zhejiang, 310003, China

RECRUITING

Children's Hospital Zagreb

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

University Hospital Center Zagreb

Zagreb, City of Zagreb, 10000, Croatia

WITHDRAWN

University Hospital of Split-Spinciceva 1

Split, 21000, Croatia

WITHDRAWN

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha, Hlavni Mesto, 100 34, Czechia

WITHDRAWN

Fakultni Thomayerova Nemocnice

Prague, Praha, Hlavni Mesto, 140 00, Czechia

WITHDRAWN

University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

Athens, Attica, 12462, Greece

RECRUITING

Children's Hospital Agia Sofia

Athens, GR11527, Greece

RECRUITING

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, 546 42, Greece

WITHDRAWN

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, 546 42, Greece

RECRUITING

Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

RECRUITING

Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrád megye, 6720, Hungary

WITHDRAWN

Clinexpert Obuda Egeszsegcentruma

Budapest, 1033, Hungary

TERMINATED

Semmelweis Egyetem, Pulmonologiai Klinika

Budapest, 1083, Hungary

RECRUITING

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Jerusalem, Jerusalem, 90000, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, Jerusalem, 91031, Israel

RECRUITING

Soroka University Medical Centre

Beersheba, 84101, Israel

WITHDRAWN

Rambam Health Care Campus PPDS

Haifa, 31096, Israel

RECRUITING

Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

Hadassah Medical Center- Ein Kerem - PPDS

Jerusalem, 91120, Israel

RECRUITING

Schneider Childrens Medical Center of Israel Petah Tikvah PIN

Petah Tikva, 49100, Israel

TERMINATED

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, 80131, Italy

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2

Naples, Campania, 80131, Italy

RECRUITING

Azienda USL di Bologna

Bologna, Emilia-Romagna, 40133, Italy

RECRUITING

Sapienza University of Rome

Rome, Lazio, 185, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

TERMINATED

Azienda Ospedaliero Universitaria A Meyer

Florence, Tuscany, 50139, Italy

TERMINATED

Universita degli Studi di Padova

Padova, Veneto, 35122, Italy

WITHDRAWN

Kurume University Hospital

Kurume-Shi, Hukuoka, 830-0011, Japan

RECRUITING

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, 861-8520, Japan

RECRUITING

Saitama Children's Medical Center-1397-1 yamane

Hidaka, Saitama, 330-8777, Japan

RECRUITING

Juntendo University Hospital

Bunkyo-Ku, Tokyo, 113-8431, Japan

RECRUITING

National Center for Child Health and Development

Setagaya-Ku, Tokyo, 157-8535, Japan

RECRUITING

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Kaunas County, LT-50161, Lithuania

WITHDRAWN

Vilnius University Hospital Santaros Klinikos

Vilnius, Vilnius County, 8406, Lithuania

WITHDRAWN

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, Lesser Poland Voivodeship, 30-663, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4

Wroclaw, Lower Silesian Voivodeship, 50-369, Poland

WITHDRAWN

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Masovian Voivodeship, 04-501, Poland

RECRUITING

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship, 04-736, Poland

RECRUITING

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Podkarpackie Voivodeship, 35-302, Poland

RECRUITING

Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50

Gdansk, Pomeranian Voivodeship, 80-803, Poland

WITHDRAWN

Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach

Katowice, Silesian Voivodeship, 40-752, Poland

WITHDRAWN

Twoja Przychodnia SCM - Slowackiego

Szczecin, West Pomeranian Voivodeship, 71-434, Poland

RECRUITING

SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251

Lodz, 91-738, Poland

RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, 93-338, Poland

RECRUITING

Narodny ustav detskych chorob

Bratislava, 833 40, Slovakia

WITHDRAWN

Kyungpook National University Chilgok hospital

Daegu, Daegu Gwang'yeogsi, 41404, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, Incheon Gwang'yeogsi, 21565, South Korea

TERMINATED

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Samsung Medical Center

Seoul, 6351, South Korea

RECRUITING

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

WITHDRAWN

Hospital Sant Joan de Deu - PIN

Barcelona, 8950, Spain

WITHDRAWN

Hospital Infantil Universitario Nino Jesus - PIN

Madrid, 28009, Spain

WITHDRAWN

Hospital Regional Universitario de Malaga Hospital Materno-Infantil

Málaga, 29011, Spain

WITHDRAWN

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

WITHDRAWN

Great Ormond Street Hospital

London, London, City of, WC1N 3AJ, United Kingdom

WITHDRAWN

Noahs Ark Childrens Hospital for Wales - PIN

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

WITHDRAWN

King's College Hospital

London, Surrey, SE5 9RS, United Kingdom

WITHDRAWN

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, Warwickshire, B4 6NH, United Kingdom

RECRUITING

Barts Health NHS Trust - PPDS

London, E1 1BB, United Kingdom

NOT YET RECRUITING

Royal Manchester Children's Hospital - PPDS - PIN

Manchester, M27 4HA, United Kingdom

WITHDRAWN

Related Links

• 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.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 5, 2022
• Study Start: May 16, 2023
• Primary Completion (Estimated): August 15, 2031
• Study Completion (Estimated): August 15, 2031
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

LI (2); CZ (2); ES (5); CA (4); KR (4); AU (4); JP (5); SL (1); BE (3); IT (7); IL (7); HU (4); GB (6); CR (3); US (22); PL (10); GR (4); CN (5)