A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
NCT ID: NCT04779307
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
121 participants
INTERVENTIONAL
2021-10-19
2025-07-01
Brief Summary
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The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease.
The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
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Detailed Description
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The study will enroll approximately 120 patients.
During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline:
* Participants ≥30 kg, Vedolizumab 300 mg
* Participants \>15 to \<30 kg, Vedolizumab 200 mg
* Participants 10 to 15 kg, Vedolizumab 150 mg
At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and weight. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows:
* Participants ≥30 kg, Vedolizumab 300 mg (High dose) or 150 mg (Low dose)
* Participants \>15 to \<30 kg, Vedolizumab 200 mg (High dose) or 100 mg (Low dose)
* Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) or 100 mg (Low dose)
The dose will remain blinded to the participant and study doctor and staff during the study (unless there is an urgent medical need). All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed during Maintenance period.
This multi-center trial will be conducted worldwide. After the Week 54 visit, participants who are younger than 18 years may be eligible to continue receiving vedolizumab in extension study MLN0002-3029 (NCT05442567). Participants who do not maintain corticosteroid-free clinical response at Week 54 or who discontinue study drug at any time during the induction or maintenance periods of this study will undergo an end of study (EOS) or early termination (ET) visit, as well as a safety visit 18 weeks after the last dose of vedolizumab, in addition these participants would enter study MLN0002-3029 for an observational long-term follow-up (LTFU) period of 2 years after the last dose of study drug in the current study. During the LTFU period, data will be collected either by clinic visit OR, if site attendance is not feasible, by phone call every 6 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Induction Period: Participants ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of ≥30 kg are included in this arm.
Vedolizumab
Vedolizumab IV infusion.
Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of \>15 to \<30 kg are included in this arm.
Vedolizumab
Vedolizumab IV infusion.
Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg are included in this arm.
Vedolizumab
Vedolizumab IV infusion.
Maintenance Period: Participants ≥30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.
Vedolizumab
Vedolizumab IV infusion.
Maintenance Period: Participants ≥30 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.
Vedolizumab
Vedolizumab IV infusion.
Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.
Vedolizumab
Vedolizumab IV infusion.
Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of \>15 to \<30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Vedolizumab
Vedolizumab IV infusion.
Maintenance Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.
Vedolizumab
Vedolizumab IV infusion.
Maintenance Period: Participants 10 to 15 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.
Vedolizumab
Vedolizumab IV infusion.
Interventions
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Vedolizumab
Vedolizumab IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Weighs ≥10 kg at the time of screening and enrollment into the study.
3. Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2) at screening endoscopy.
4. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.
5. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
6. Has 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.
7. Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.
Exclusion Criteria
2. Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
3. Has 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.
4. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 30 days prior to first dose of study drug.
5. Has received any live vaccinations within 30 days prior to first dose of study drug.
6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
7. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
8. Participants with a current diagnosis of indeterminate colitis.
9. Participants with clinical features suggesting monogenic very early onset inflammatory bowel disease.
10. Participant with 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. NOTE: If participants have received Bacillus Calmette-Guérin vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune participants (ie, 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.
Participants with chronic hepatitis C virus (HCV) (ie, positive HCV antibody \[HCVAb\] and HCV RNA). Note: Subjects 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 participant has evidence of dysplasia or history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
13. Has positive stool studies for ova and/or parasites or stool culture at screening visit.
14. Has positive Clostridioides difficile (C difficile) stool test at screening visit.
2 Years
17 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Locations
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Phoenix Childrens Hospital -1919 E Thompson Rd
Phoenix, Arizona, United States
Rady Childrens Hospital San Diego - PIN
San Diego, California, United States
Childrens Center For Digestive Healthcare
Atlanta, Georgia, United States
Advocate Children's Hospital Park Ridge
Park Ridge, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, United States
Mayo Clinic - PIN
Rochester, Minnesota, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
UPMC Children's Hospital of Pittsburgh-120 Lytton Ave
Pittsburgh, Pennsylvania, United States
Texas Childrens Hospital West Campus
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
Universitaire Ziekenhuizen(UZ)Leuven-Campus Gasthuisberg
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
Beijing Children's Hospital, Capital Medical University - PIN
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 University School of Medicine
Hangzhou, Zhejiang, China
Klinika Za Djecje Bolesti Zagreb
Zagreb, City of Zagreb, Croatia
Children's Hospital "Agia Sofia"
Athens, Attica, Greece
Attikon University General Hospital
Chaïdári, Attica, Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
Clinexpert Gyogycentrum
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, , Hungary
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Medical Center - PPDS
Jerusalem, Jerusalem, Israel
Rambam Medical Center - PPDS
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, Italy
Azienda USL di Bologna
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Universita di Roma La Sapienza
Rome, Lazio, Italy
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo
Monza, Monza E Brianza, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, Italy
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli - Piazza Luigi Miraglia, 2
Napoli, , Italy
Kurume University Hospital
Kurume, Hukuoka, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Saitama Children's Medical Center
Saitama, , Japan
Uniwersytecki Szpital Dzieciecy
Krakow, Lesser Poland 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
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 - ul. Pomorska 251
Lodz, Łódź Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Gachon University Gil Medical Center
Seoul, Incheon Gwang'yeogsi, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
The Royal London Hospital
London, London, City of, United Kingdom
Great Ormond Street Hospital
London, London, City of, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Noahs Ark Childrens Hospital for Wales
Cardiff, , United Kingdom
Countries
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Related Links
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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
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2020-004300-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2071210030
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-509018-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
MLN0002-3024
Identifier Type: -
Identifier Source: org_study_id
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