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RECRUITING

NCT04779320

PHASE3

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

Official title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2022-02-10

Completion Date

2026-05-22

Last Updated

2025-10-20

Healthy Volunteers

Conditions

Crohn's Disease (CD)

Interventions

DRUG

Vedolizumab IV

Main Inclusion Criteria: 1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC). 2. The participants weigh ≥10 kg at the time of screening and enrollment into the study. 3. Participants with Crohn's disease (CD) diagnosed at least 1 month before screening. Participants with moderately to severely active CD defined by a Pediatric Crohn's Disease Activity Index (PCDAI) \>30 and an simple endoscopic score for Crohn's Disease (SES-CD) \>6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy. 4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition. 5. Participants with extensive colitis or pancolitis of \>8 years' duration or left-sided colitis of \>12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening. 6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines. Main Exclusion Criteria: 1. Participants who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period. 2. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease. 3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 30 days prior to first dose of study drug. 4. The participants has received any live vaccinations within 30 days prior to first dose. 5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study. 6. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \>3 small intestine resections. 7. Participants with a current diagnosis of indeterminate colitis. 8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease. 9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as: * Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR * A TB skin test reaction ≥5 mm. 10. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants(i.e., hepatitis B surface antigen \[HBsAg\]-negative and hepatitis B antibody-positive) may, however, be included. Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if the absence of HBV DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory. 11. Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA). Note: Participants who are HCVAb-positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks before baseline\]). 12. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation). 13. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. 14. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit. 15. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit. Other inclusion/exclusion criteria may apply.

Locations (96)

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Rady Childrens Hospital San Diego - PIN

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

I.H.S Health LLC

Kissimmee, Florida, United States

Childrens Center For Digestive Healthcare

Atlanta, Georgia, United States

Advocate Children's Hospital Park Ridge

Park Ridge, Illinois, United States

Riley Hospital For Children

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

MNGI Digestive Health, PA

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 of Rochester Medical Center PPDS

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

SUNY Upstate Medical Center

Syracuse, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Hasbro Children's Hospital

Providence, Rhode Island, 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

UZ Leuven

Leuven, Vlaams Brabant, Belgium

University of Alberta Hospital

Edmonton, Alberta, Canada

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

London Health Sciences Centre

London, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Beijing Children Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Henan Children's Hospital(Zhengzhou Children's Hospital)

Zhengzhou, Henan, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

The Children's Hospital Zhejiang UniversitySchool of Medicine

Hangzhou, Zhejiang, China

Klinika Za Djecje Bolesti Zagreb

Zagreb, City of Zagreb, Croatia

University Hospital Center Zagreb

Zagreb, City of Zagreb, Croatia

University Hospital Centre Split

Split, Croatia

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha, Hlavni Mesto, Czechia

Fakultni Thomayerova Nemocnice

Prague, Praha, Hlavni Mesto, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Attikon University General Hospital

Athens, Attica, Greece

Children's Hospital "Agia Sofia"

Athens, Greece

Ippokratio General Hospital of Thessaloniki

Thessaloniki, Greece

Ippokratio General Hospital of Thessaloniki

Thessaloniki, Greece

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, Borsod-Abauj Zemplen county, Hungary

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrád megye, Hungary

Semmelweis Egyetem

Budapest, Hungary

Schneider Childrens Medical Center of Israel Petah Tikvah PIN

Petah Tikva, Central District, Israel

Tel Aviv Sourasky Medical Center PPDS

Jerusalem, Jerusalem, Israel

Soroka University Medical Centre

Beersheba, Israel

Rambam Medical Center - PPDS

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center - PPDS

Jerusalem, Israel

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli

Naples, Campania, Italy

Azienda Ospedaliera Universitaria Federico II

Naples, Campania, Italy

Azienda USL di Bologna

Bologna, Emilia-Romagna, Italy

Sapienza University of Rome

Rome, Lazio, Italy

ASST di Monza - Azienda Ospedaliera San Gerardo

Monza, Lombardy, Italy

Universita degli Studi di Padova

Padova, Veneto, Italy

Kurume University Hospital

Kurume-Shi, Hukuoka, Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Juntendo University Hospital

Bunkyo-Ku, Tokyo, Japan

National Center for Child Health and Development

Setagaya-Ku, Tokyo, Japan

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Kaunas County, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Vilnius County, Lithuania

Uniwersytecki Szpital Dzieciecy

Krakow, Lesser Poland Voivodeship, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Masovian Voivodeship, Poland

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, Masovian Voivodeship, Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Podkarpackie Voivodeship, Poland

Copernicus Podmiot Leczniczy Sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

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

Katowice, Silesian Voivodeship, Poland

Twoja Przychodnia SCM

Szczecin, West Pomeranian Voivodeship, Poland

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Łódź Voivodeship, Poland

Detska fakultna nemocnica s poliklinikou Banska Bystrica

Banská Bystrica, Slovakia

Narodny ustav detskych chorob

Bratislava, Slovakia

Kyungpook National University Chilgok hospital

Daegu, Daegu Gwang'yeogsi, South Korea

Gachon University Gil Medical Center

Incheon, Incheon Gwang'yeogsi, South Korea

Seoul National University Hospital

Seongnam, South Korea

Samsung Medical Center - PPDS

Seoul, South Korea

Hospital Sant Joan de Deu - PIN

Esplugues de Llobregat, Barcelona, Spain

Hospital de Sagunto

Sagunto, Valencia, Spain

Hospital Infantil Universitario Nino Jesus - PIN

Madrid, Spain

Hospital Regional Universitario de Malaga - Hospital Materno Infantil

Málaga, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Kings College Hospital

London, London, City of, United Kingdom

Great Ormond Street Hospital (GOSH)

London, London, City of, United Kingdom

Noahs Ark Childrens Hospital for Wales - PPDS - PIN

Cardiff, South Glamorgan, United Kingdom

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Royal Manchester Children's Hospital - PPDS

Manchester, United Kingdom