Ulcerative ColitisPhase 3NCT05442567
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3 study testing Vedolizumab IV in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 98 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Vedolizumab IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 98 sitesin 18 countries
- Study dates
- 16 May 2023to 7 Feb 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Main Inclusion Criteria:
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.
Main Exclusion Criteria:
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.
Trial locations and contacts
98 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
98 sites in 18 countries
United States22 sites, 8 recruiting
- Not yet recruiting
Childrens Center For Digestive Healthcare
Atlanta, Georgia, 30342
Site Contact
Benjamin Gold
- Withdrawn
Johns Hopkins University
Baltimore, Maryland, 21287
- Withdrawn
Boston Children's Hospital - PIN
Boston, Massachusetts, 02215
- Not yet recruiting
University Hospitals Cleveland Medical Center - 11100 Euclid Ave
Cleveland, Ohio, 44106
Site Contact
Thomas Sferra
- Not yet recruiting
Texas Children's Hospital - Baylor - PIN
Houston, Texas, 77030
Site Contact
Faith Ihekweazu
- Withdrawn
Riley Hospital For Children - PIN
Indianapolis, Indiana, 46202
- Withdrawn
I.H.S Health LLC-Kissimmee-445 W Oak St
Kissimmee, Florida, 34741
- Withdrawn
Cedars Sinai Medical Center - 127 San Vicente Blvd
Los Angeles, California, 90048
- Terminated
MNGI Digestive Health PA-Plymouth
Minneapolis, Minnesota, 55413
- Not yet recruiting
University of South Alabama (USA) Physicians Group
Mobile, Alabama, 36604
Site Contact
David Gremse
- Terminated
Goryeb Children's Hospital
Morristown, New Jersey, 07960
- Withdrawn
Cohen Children's Medical Center Northwell - BRANY - PPDS - PIN
New Hyde Park, New York, 11042
- Recruiting
Advocate Children's Hospital - Park Ridge - PIN
Park Ridge, Illinois, 60068
Site Contact
Kiranmai Gorla
- Recruiting
Phoenix Childrens Hospital - Thomas Rd - PIN
Phoenix, Arizona, 85016
Site Contact
Ashish Patel
- Withdrawn
UPMC Children's Hospital of Pittsburgh - Adolescent Medicine (Oakland) - PIN
Pittsburgh, Pennsylvania, 15201
- Withdrawn
Hasbro Children's Hospital - PIN
Providence, Rhode Island, 02903
- Recruiting
Carilion Children's Tanglewood Center
Roanoke, Virginia, 24018
Site Contact
Monica Garin-Laflam
- Terminated
Mayo Clinic - PIN
Rochester, Minnesota, 55905
- Withdrawn
University of Rochester Medical Center - PPDS
Rochester, New York, 14642
- Not yet recruiting
Rady Children's Hospital - San Diego - PIN
San Diego, California, 92123
Site Contact
Jeannie Huang
- Withdrawn
University of California San Francisco
San Francisco, California, 94158
- Withdrawn
Stony Brook University Medical Center
Stony Brook, New York, 11794
Poland10 sites, 7 recruiting
- Withdrawn
Copernicus Podmiot Leczniczy Sp. z o.o. - al. Jana Pawla II 50
Gdansk, Pomeranian Voivodeship, 80-803
- Withdrawn
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
Katowice, Silesian Voivodeship, 40-752
- Recruiting
Uniwersytecki Szpital Dzieciecy w Krakowie
Krakow, Lesser Poland Voivodeship, 30-663
Site Contact
Kinga Kowalska-Duplaga
- Recruiting
SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
Lodz, 91-738
Site Contact
Ewa Toporowska-Kowalska
- Recruiting
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, 93-338
Site Contact
Elzbieta Czkwianianc
- Recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, 35-302
Site Contact
Bartosz Korczowski
- Recruiting
Twoja Przychodnia SCM - Slowackiego
Szczecin, West Pomeranian Voivodeship, 71-434
Site Contact
Beata Gawdis-Wojnarska
- Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, 04-501
Site Contact
Monika Meglicka
- Recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship, 04-736
Site Contact
Jaroslaw Kierkus
- Withdrawn
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu-ul.Ludwika Pasteura 4
Wroclaw, Lower Silesian Voivodeship, 50-369
Israel7 sites, 5 recruiting
- Withdrawn
Soroka University Medical Centre
Beersheba, 84101
- Recruiting
Rambam Health Care Campus PPDS
Haifa, 31096
Site Contact
Ron Shaoul
- Recruiting
Carmel Medical Center
Haifa, 34362
Site Contact
Reut Batcir
- Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Jerusalem, Jerusalem, 90000
Site Contact
Shlomi Cohen
- Recruiting
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 91031
Site Contact
Dan Turner
- Recruiting
Hadassah Medical Center- Ein Kerem - PPDS
Jerusalem, 91120
Site Contact
Zev Davidovics
- Terminated
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
Petah Tikva, 49100
Italy7 sites, 4 recruiting
- Recruiting
Azienda USL di Bologna
Bologna, Emilia-Romagna, 40133
Site Contact
Patrizia Alvisi
- Terminated
Azienda Ospedaliero Universitaria A Meyer
Florence, Tuscany, 50139
- Terminated
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, 20900
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples, Campania, 80131
Site Contact
Erasmo Miele
- Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli - Piazza Luigi Miraglia 2
Naples, Campania, 80131
Site Contact
Caterina Strisciuglio
- Withdrawn
Universita degli Studi di Padova
Padova, Veneto, 35122
- Recruiting
Sapienza University of Rome
Rome, Lazio, 185
Site Contact
Salvatore Oliva
United Kingdom6 sites, 2 recruiting
- Recruiting
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, Warwickshire, B4 6NH
Site Contact
Rafeeq Muhammed
- Withdrawn
Noahs Ark Childrens Hospital for Wales - PIN
Cardiff, South Glamorgan, CF14 4XW
- Withdrawn
Great Ormond Street Hospital
London, London, City of, WC1N 3AJ
- Withdrawn
King's College Hospital
London, Surrey, SE5 9RS
- Not yet recruiting
Barts Health NHS Trust - PPDS
London, E1 1BB
Site Contact
Sandhia Naik
- Withdrawn
Royal Manchester Children's Hospital - PPDS - PIN
Manchester, M27 4HA
China5 sites, 5 recruiting
- Not yet recruiting
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, Beijing Municipality, 100045
Site Contact
Jie Wu
- Recruiting
Hunan Children's Hospital
Changsha, Hunan, 410007
Site Contact
Hongmei Zhao
- Recruiting
The Children's Hospital Zhejiang University School of Medicine - Binjiang Campus
Hangzhou, Zhejiang, 310003
Site Contact
Jie Chen
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Site Contact
Ying Huang
- Recruiting
Henan Children's Hospital Zhengzhou Children's Hospital - Zhengdong Campus
Zhengzhou, Henan, 450018
Site Contact
Xiaoqin Li
Japan5 sites, 5 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431
Site Contact
Takahiro Kudo
- Recruiting
Saitama Children's Medical Center-1397-1 yamane
Hidaka, Saitama, 330-8777
Site Contact
Itaru Iwama
- Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, 861-8520
Site Contact
Yugo Takaki
- Recruiting
Kurume University Hospital
Kurume-Shi, Hukuoka, 830-0011
Site Contact
Tatsuki Mizuochi
- Recruiting
National Center for Child Health and Development
Setagaya-Ku, Tokyo, 157-8535
Site Contact
Katsuhiro Arai
Spain5 sites
- Withdrawn
Hospital Sant Joan de Deu - PIN
Barcelona, 8950
- Withdrawn
Hospital Infantil Universitario Nino Jesus - PIN
Madrid, 28009
- Withdrawn
Hospital Regional Universitario de Malaga Hospital Materno-Infantil
Málaga, 29011
- Withdrawn
Hospital de Sagunto
Sagunto, Valencia, 46520
- Withdrawn
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Australia4 sites, 4 recruiting
- Not yet recruiting
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
Site Contact
Edward Giles
- Recruiting
Royal Children's Hospital Melbourne - PIN
Parkville, Victoria, 3052
Site Contact
George Alex
- Recruiting
Queensland Childrens Hospital
South Brisbane, Queensland, 4101
Site Contact
Christopher Burgess
- Recruiting
Children's Hospital at Westmead
Westmead, New South Wales, 2145
Site Contact
Shoma Dutt
Canada4 sites
- Withdrawn
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
- Terminated
London Health Sciences Centre -800 Commissioners Rd E
London, Ontario, N6A 5W9
- Withdrawn
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
- Withdrawn
British Columbia Children's Hospital - 4480 Oak St
Vancouver, British Columbia, V6H 3N1
Greece4 sites, 3 recruiting
- Recruiting
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Athens, Attica, 12462
Site Contact
Smaragdi Fessatou
- Recruiting
Children's Hospital Agia Sofia
Athens, GR11527
Site Contact
Alexandra Papadopoulou
- Withdrawn
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, 546 42
- Recruiting
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, 546 42
Site Contact
Ioannis Xinias
Hungary4 sites, 2 recruiting
- Terminated
Clinexpert Obuda Egeszsegcentruma
Budapest, 1033
- Recruiting
Semmelweis Egyetem, Pulmonologiai Klinika
Budapest, 1083
Site Contact
Aron Cseh
- Recruiting
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, Borsod-Abauj Zemplen county, 3526
Site Contact
Erzsebet Szakos
- Withdrawn
Szegedi Tudomanyegyetem, SZAKK, Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrád megye, 6720
South Korea4 sites, 3 recruiting
- Recruiting
Kyungpook National University Chilgok hospital
Daegu, Daegu Gwang'yeogsi, 41404
Site Contact
Ben Kang
- Terminated
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, 21565
- Recruiting
Seoul National University Hospital
Seoul, 03080
Site Contact
Jin Soo Moon
- Recruiting
Samsung Medical Center
Seoul, 6351
Site Contact
Yon-Ho Choe
Belgium3 sites, 3 recruiting
- Recruiting
UZ Antwerpen - PIN
Edegem, Antwerpen, 2650
Site Contact
Els Van de Vijver
- Recruiting
UZ Brussel - PIN
Jette, Brussels Capital, 1090
Site Contact
Elisabeth De Greef
- Recruiting
UZ Leuven
Leuven, Vlaams Brabant, 3000
Site Contact
Ilse Hoffman
Croatia3 sites, 1 recruiting
- Withdrawn
University Hospital of Split-Spinciceva 1
Split, 21000
- Recruiting
Children's Hospital Zagreb
Zagreb, City of Zagreb, 10000
Site Contact
Iva Hojsak
- Withdrawn
University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000
Czechia2 sites
- Withdrawn
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha, Hlavni Mesto, 100 34
- Withdrawn
Fakultni Thomayerova Nemocnice
Prague, Praha, Hlavni Mesto, 140 00
Lithuania2 sites
- Withdrawn
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Kaunas County, LT-50161
- Withdrawn
Vilnius University Hospital Santaros Klinikos
Vilnius, Vilnius County, 8406
About this study
Official title: A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
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.
Read the detailed description
This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 [participants with UC] and MLN0002-3025 [participants with CD], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort.
Treatment Cohort:
The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD.
Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant. At this study entry, participants will be administered the same blinded dose of vedolizumab IV that was received at Week 46 in the parent study and will then continue to receive vedolizumab IV at a frequency of once every 8 weeks (Q8W) in the following treatment groups:
- Participants 10 to ≤15 kilogram (kg), Vedolizumab 150 milligram (mg) (High dose)
- Participants 10 to ≤15 kg, Vedolizumab 100 mg (Low dose)
- Participants >15 to <30 kg, Vedolizumab 200 mg (High dose)
- Participants >15 to <30 kg, Vedolizumab 100 mg (Low dose)
- Participants ≥30 kg, Vedolizumab 300 mg (High dose)
- Participants ≥30 kg, Vedolizumab 150 mg (Low dose)
Blinding of dose group assignment of the parent study will continue until the respective parent study is unblinded in order to protect the blinding of the parent study.
The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first. Participants who complete or are discontinued from the study for any reason will complete the final safety/end of study (EOS) visit 18 weeks after their last dose of study drug.
Observational Cohort:
Participants who received at least 1 dose of study drug during parent study and early terminated or are not eligible for the Treatment Cohort of this study after completion of the Week 54 visit of parent study, will be enrolled in the Observational Cohort of this study as part of a long-term follow-up period to assess prespecified safety events of interest and will not receive continued treatment with vedolizumab IV.
The overall time to participate in the Observational Cohort is up to approximately 2 years.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Vedolizumab IV, No Intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab IVDrug
Also called MLN0002, ENTYVIO, KYNTELES
Vedolizumab IV infusion
No InterventionOther
Participants will not receive any intervention in the Observational Cohort.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to approximately 2 years
Secondary outcomes (8)
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
Major IBD-related events include hospitalizations, surgeries, and procedures in pediatric participants with UC or CD.
Measured: 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
The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The total score is an average of all item scores. The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Measured: 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
The IMPACT-III Bowel Symptom Subscale is a self-reported measure with 7 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The bowel symptom subscale score ranges from 1 to 35, with higher scores indicating lesser bowel symptoms. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Measured: 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
The IMPACT-III Systemic Symptom Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The Systemic symptom subscale score ranges from 1 to 15, with higher scores indicating lesser systemic symptoms. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Measured: 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
The IMPACT-III Social Functioning Subscale is a self-reported measure with 12 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The social functioning subscale score ranges from 1 to 60, with higher scores indicating better social functioning. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Measured: 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 Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
The IMPACT-III Body Image Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The body image subscale score ranges from 1 to 15, with higher scores indicating better body image. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Measured: 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 Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
The IMPACT-III Treatment/Intervention Subscale is a self-reported measure with 3 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The treatment/intervention subscale score ranges from 1 to 15, with higher scores indicating ease of administration of treatment/interventions. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Measured: 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 Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
The IMPACT-III Emotional Functioning Subscale is a self-reported measure with 7 closed questions. It uses a 5-point Likert scale ranging from 1 (bad 'quality of life' condition) to 5 (good 'quality of life' condition) for all answers. The emotional functioning subscale score ranges from 1 to 35, with higher scores indicating better emotional functioning. This outcome will be assessed in participants who were aged 9 to 17 years at the time of first dose of study drug in study MLN0002-3024 or MLN0002-3025. Baseline refers to the Baseline of study MLN0002-3024 or MLN0002-3025.
Measured: Baseline, every 24 weeks in this study (up to approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start16 May 2023
- Primary completion7 Feb 2033 (estimated)
- Study completion7 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442567
- Sponsor's protocol ID
- MLN0002-3029
- Other IDs
- 2023-509046-36-00, jRCT2071230036, 2023
- Status last verified
- May 2026
- First submitted
- 30 Jun 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease
- ClinicalTrials.gov ID
- NCT05442567
- Acronym / sponsor ID
- MLN0002-3029
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 16 May 2023 (actual)
- Primary completion
- 7 Feb 2033 (estimated)
- Study completion
- 7 Feb 2033 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multi-center trial is conducted worldwide. Up to 240 patients would be enrolled from Studies MLN0002-3024 [participants with UC] and MLN0002-3025 [participants with CD], either in the Treatment Cohort or in the Observational Cohort. Approximately 93 participants who have previously participated either in study MLN0002-3024 or MLN0002-3025, referred to as parent study, are expected to roll over to the MLN0002-3029 study in the treatment cohort.
Treatment Cohort:
The drug being tested in this study is called vedolizumab, being studied to treat pediatric patients who have UC or CD.
Participants eligible for the Treatment Cohort can be administered vedolizumab intravenous (IV) at Week 54 visit of parent study or up to 1 week after Week 54 of the parent study based on the availability of test results needed to assess eligibility of the participant. At this study entry, participants will be administered the same blinded dose of vedolizumab IV that was received at Week 46 in the parent study and will then continue to receive vedolizumab IV at a frequency of once every 8 weeks (Q8W) in the following treatment groups:
- Participants 10 to ≤15 kilogram (kg), Vedolizumab 150 milligram (mg) (High dose)
- Participants 10 to ≤15 kg, Vedolizumab 100 mg (Low dose)
- Participants >15 to <30 kg, Vedolizumab 200 mg (High dose)
- Participants >15 to <30 kg, Vedolizumab 100 mg (Low dose)
- Participants ≥30 kg, Vedolizumab 300 mg (High dose)
- Participants ≥30 kg, Vedolizumab 150 mg (Low dose)
Blinding of dose group assignment of the parent study will continue until the respective parent study is unblinded in order to protect the blinding of the parent study.
The overall time to participate in the Treatment Cohort of this study is up to participant withdrawal, or until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available, or Sponsor's decision for study closure, or for up to approximately 5 years, whichever comes first. Participants who complete or are discontinued from the study for any reason will complete the final safety/end of study (EOS) visit 18 weeks after their last dose of study drug.
Observational Cohort:
Participants who received at least 1 dose of study drug during parent study and early terminated or are not eligible for the Treatment Cohort of this study after completion of the Week 54 visit of parent study, will be enrolled in the Observational Cohort of this study as part of a long-term follow-up period to assess prespecified safety events of interest and will not receive continued treatment with vedolizumab IV.
The overall time to participate in the Observational Cohort is up to approximately 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg | Experimental | Drug: Vedolizumab IVEligible 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. |
| Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg | Experimental | Drug: Vedolizumab IVEligible 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. |
| Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg | Experimental | Drug: Vedolizumab IVEligible 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. |
| Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg | Experimental | Drug: Vedolizumab IVEligible 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. |
| Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg | Experimental | Drug: Vedolizumab IVEligible 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. |
| Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg | Experimental | Drug: Vedolizumab IVEligible 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. |
| Observational Cohort: Early Terminated Participants From Parent Studies | Other | Other: No InterventionParticipants 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab IVAlso: MLN0002, ENTYVIO, KYNTELESVedolizumab IV infusion | Drug | 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 InterventionParticipants will not receive any intervention in the Observational Cohort. | Other | Observational Cohort: Early Terminated Participants From Parent Studies |
Primary outcome
Treatment Cohort: Number of Participants With at Least One Adverse Event (AE)
Time frame: From first dose of study drug up to approximately 5 years
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.
Observational Cohort: Number of Participants With Prespecified Safety Events
Time frame: Up to approximately 2 years
Prespecified safety events will include serious infections, malignancies, progressive multifocal leukoencephalopathy (PML), concerns about growth and pubertal development, and bowel surgery.
8 secondary outcomes
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Body Image Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: 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 Treatment/Intervention Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: 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 Emotional Functioning Subscale Score for Participants Aged 9 to 17 Years for Every 24 Weeks
Time frame: Baseline, every 24 weeks in this study (up to approximately 5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Takeda
98 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vedolizumab IV in people with Ulcerative Colitis and Crohn's Disease, run by Takeda at 98 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Poland, Israel, Italy, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Cohort: Number of Participants With at Least One Adverse Event (AE) (time frame: From first dose of study drug up to approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.