A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease

Status: Recruiting
Location: See all (68) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

⁃ 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:

⁃ 1\. 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.

Locations
United States
Arizona
Phoenix Childrens Hospital -1919 E Thompson Rd
RECRUITING
Phoenix
California
Rady Childrens Hospital San Diego - PIN
NOT_YET_RECRUITING
San Diego
Georgia
Childrens Center For Digestive Healthcare
NOT_YET_RECRUITING
Atlanta
Illinois
Advocate Children's Hospital Park Ridge
NOT_YET_RECRUITING
Park Ridge
Massachusetts
Boston Children's Hospital
NOT_YET_RECRUITING
Boston
Maryland
Johns Hopkins University
NOT_YET_RECRUITING
Baltimore
Minnesota
MNGI Digestive Health PA-Plymouth
RECRUITING
Minneapolis
Mayo Clinic - PIN
NOT_YET_RECRUITING
Rochester
New Jersey
Goryeb Children's Hospital
NOT_YET_RECRUITING
Morristown
New York
The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS
NOT_YET_RECRUITING
New Hyde Park
Ohio
University Hospitals Cleveland Medical Center
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Children's Hospital of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
Texas
Texas Children's Hospital
NOT_YET_RECRUITING
Houston
Virginia
Carilion Children's Tanglewood Center
NOT_YET_RECRUITING
Roanoke
Other Locations
Australia
Monash Health, Monash Medical Centre
NOT_YET_RECRUITING
Clayton
Royal Children's Hospital Melbourne - PIN
RECRUITING
Parkville
Queensland Childrens Hospital
NOT_YET_RECRUITING
South Brisbane
Children's Hospital at Westmead
RECRUITING
Westmead
Belgium
UZ Antwerpen
NOT_YET_RECRUITING
Edegem
Universitair Ziekenhuis Brussel - PIN
NOT_YET_RECRUITING
Jette
UZ Leuven
RECRUITING
Leuven
Canada
University of Alberta Hospital
NOT_YET_RECRUITING
Edmonton
London Health Sciences Centre
NOT_YET_RECRUITING
London
British Columbia Children's Hospital
NOT_YET_RECRUITING
Vancouver
China
Beijing Children Hospital,Capital Medical University
NOT_YET_RECRUITING
Beijing
The Children's Hospital Zhejiang UniversitySchool of Medicine
NOT_YET_RECRUITING
Hangzhou
Children's Hospital of Fudan University
RECRUITING
Shanghai
Henan Children's Hospital (Zhengzhou Children's Hospital)
RECRUITING
Zhengzhou
Croatia
Klinika Za Djecje Bolesti Zagreb
RECRUITING
Zagreb
Greece
Attikon University General Hospital
NOT_YET_RECRUITING
Athens
Children's Hospital Agia Sofia
NOT_YET_RECRUITING
Athens
Ippokratio General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Semmelweis Egyetem
RECRUITING
Budapest
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz
NOT_YET_RECRUITING
Miskolc
Israel
Carmel Medical Center
NOT_YET_RECRUITING
Haifa
Rambam Medical Center - PPDS
RECRUITING
Haifa
Hadassah Medical Center - PPDS
RECRUITING
Jerusalem
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Schneider Childrens Medical Center of Israel Petah Tikvah PIN
NOT_YET_RECRUITING
Petah Tikva
Tel Aviv Sourasky Medical Center PPDS
RECRUITING
Tel Aviv
Italy
Azienda USL di Bologna
RECRUITING
Bologna
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza A. O. San Gerardo
RECRUITING
Monza
AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
NOT_YET_RECRUITING
Napoli
Azienda Ospedaliera Universitaria Federico II
NOT_YET_RECRUITING
Napoli
Universita degli Studi di Padova
NOT_YET_RECRUITING
Padua
Sapienza University of Rome
NOT_YET_RECRUITING
Rome
Japan
Juntendo University Hospital
NOT_YET_RECRUITING
Bunkyo-ku
Japanese Red Cross Kumamoto Hospital
NOT_YET_RECRUITING
Kumamoto
Kurume University Hospital
NOT_YET_RECRUITING
Kurume-shi
National Center for Child Health and Development
NOT_YET_RECRUITING
Setagaya-ku
Poland
Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach
NOT_YET_RECRUITING
Katowice
Uniwersytecki Szpital Dzieciecy
NOT_YET_RECRUITING
Krakow
Instytut Centrum Zdrowia Matki Polki
NOT_YET_RECRUITING
Lodz
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
NOT_YET_RECRUITING
Lodz
Korczowski Bartosz, Gabinet Lekarski
NOT_YET_RECRUITING
Rzeszów
Twoja Przychodnia SCM
RECRUITING
Szczecin
Instytut Pomnik Centrum Zdrowia Dziecka
NOT_YET_RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
NOT_YET_RECRUITING
Warsaw
Republic of Korea
Kyungpook National University Chilgok hospital
NOT_YET_RECRUITING
Daegu
Gachon University Gil Medical Center
NOT_YET_RECRUITING
Incheon
Samsung Medical Center - PPDS
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Slovakia
Narodny ustav detskych chorob
NOT_YET_RECRUITING
Bratislava
United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
NOT_YET_RECRUITING
Birmingham
Noahs Ark Childrens Hospital for Wales - PPDS - PIN
NOT_YET_RECRUITING
Cardiff
Barts Health NHS Trust
NOT_YET_RECRUITING
London
Great Ormond Street Hospital (GOSH)
NOT_YET_RECRUITING
London
Royal Manchester Children's Hospital - PPDS
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2023-05-16
Estimated Completion Date: 2031-08-15
Participants
Target number of participants: 240
Treatments
Experimental: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 150 mg
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.
Experimental: Treatment Cohort: Participants 10 to ≤15 kg, Vedolizumab 100 mg
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.
Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 200 mg
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.
Experimental: Treatment Cohort: Participants >15 to <30 kg, Vedolizumab 100 mg
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.
Experimental: Treatment Cohort: Participants ≥30 kg, Vedolizumab 300 mg
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.
Experimental: Treatment Cohort: Participants ≥30 kg, Vedolizumab 150 mg
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.
Other: Observational Cohort: Early Terminated Participants From Parent Studies
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.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov