Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.

Study Overview

• Status: Completed
• Conditions: Hematopoietic Stem Cells
• Intervention / Treatment: Drug: Vedolizumab; Drug: Vedolizumab Placebo

Detailed Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who are undergoing allo-HSCT transplantation. This study will look at the efficacy and safety of vedolizumab in the prophylaxis of intestinal aGvHD in participants undergoing allo-HSCT transplantation.

The study will enroll approximately 558 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need) along with background GvHD prophylaxis regimen:

• Vedolizumab 300 mg
• Placebo (dummy inactive intravenous infusion)

This multi-center trial will be conducted Worldwide. The overall time to participate in this study is 12 months.

• Study Type: Interventional
• Enrollment (Actual): 343
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aires, Argentina, C1199ABB
    • Hospital Italiano de Buenos Aires
  • Cordoba, Argentina, X5014KEH
    • Hospital Privado Centro Médico de Córdoba
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1093AAS
      • Fundacion Favaloro Hospital Universitario
• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Saint Vincent's Hospital Sydney
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Royal Brisbane and Women's Hospital
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Ordensklinikum Linz Elisabethinen
• Belgium
  • Antwerpen, Belgium, 2060
    • Ziekenhuisnetwerk Stuivenberg
  • Flemish Brabant
    • Leuven, Flemish Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven
• Brazil
  • Sao Paulo, Brazil, 08270-070
    • Hospital Santa Marcelina
  • Sao Paulo, Brazil, 01246-000
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  • Sao Paulo, Brazil, 01509-010
    • Fundacao Antonio Prudente - A.C.Camargo Cancer Center
  • Sao Paulo, Brazil, 03102-006
    • Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncolgia
  • Ceara
    • Fortaleza, Ceara, Brazil, 60430-380
      • Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
  • Parana
    • Curitiba, Parana, Brazil, 80510-130
      • Instituto do Cancer e Transplante de Curitiba
  • SAO Paulo
    • Barretos, SAO Paulo, Brazil, 14784-400
      • Hospital de Cancer de Barretos
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatchewan Cancer Agency
• France
  • Bretagne
    • Rennes Cedex 9, Bretagne, France, 35033
      • Hôpital Pontchaillou
  • Ile-de-france
    • Paris, Ile-de-france, France, 75012
      • Hôpital Saint-Antoine
    • Paris, Ile-de-france, France, 75013
      • Groupe Hospitalier Pitie-Salpetriere
    • Paris, Ile-de-france, France, 75473 cedex 15
      • Hôpital Necker-Enfants Malades
    • Paris Cedex 10, Ile-de-france, France, 75475
      • Hopital Saint Louis
  • Limousin, Lorraine
    • Limoges Cedex, Limousin, Lorraine, France, 87042
      • Centre Hospitalier Universitaire de Limoges
  • PAYS DE LA Loire
    • Nantes Cedex 1, PAYS DE LA Loire, France, 44093
      • Centre Hospitalier Universitaire Nantes - Hotel Dieu
  • Picardie
    • Amiens, Picardie, France, 80054 CEDEX 1
      • Centre Hospitalier Universitaire Amiens-Picardie
• Germany
  • Baden-wuerttemberg
    • Mannheim, Baden-wuerttemberg, Germany, 68167
      • Universitätsmedizin Mannheim
    • Stuttgart, Baden-wuerttemberg, Germany, 70176
      • Diakonie-Klinikum Stuttgart
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt
  • Rheinland-pfalz
    • Mainz, Rheinland-pfalz, Germany, 55131
      • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus Dresden
  • Sachsen-anhalt
    • Halle, Sachsen-anhalt, Germany, 06120
      • Universitätsklinikum Halle
  • Schleswig-holstein
    • Kiel, Schleswig-holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
• Greece
  • Attica
    • Athens, Attica, Greece, 12462
      • University General Hospital of Athens Attikon
  • Peloponnese
    • Patras, Peloponnese, Greece, 26504
      • University Regional General Hospital of Patras
• Hungary
  • Hajdu-bihar
    • Debrecen, Hajdu-bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus - Rambam Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center
  • Ramat Gan, Israel, 5265601
    • The Chaim Sheba Medical Center
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center
  • Beersheba
    • Beer Sheva, Beersheba, Israel, 84101
      • Soroka University Medical Center
• Italy
  • Ancona, Italy, 60126
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • Bari, Italy, 70124
    • Azienda Ospedaliera Policlinico Di Bari
  • Catania, Italy, 95124
    • Policlinico Universitario di Catania
  • Milano, Italy, 20162
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Milano, Italy, 20089'
    • Istituto Clinico Humanitas Humanitas Cancer Center
  • Pescara, Italy, 65125
    • Presidio Ospedaliero di Pescara
  • Calabria
    • Reggio Calabria, Calabria, Italy, 89122
      • Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli
  • Lecce
    • Tricase, Lecce, Italy, 73039
      • Azienda Ospedaliera Cardinale G. Panico
  • Marche
    • Ascoli Piceno, Marche, Italy, 63100
      • Ospedale Mazzoni
  • Venezia
    • Mestre, Venezia, Italy, 30174
      • Ospedale dell'Angelo
• Japan
  • Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 453-8511
      • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 730-8619
      • Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Okayama
    • Okayama-city, Okayama, Japan, 700-8558
      • Okayama University Hospital
  • Shizuoka
    • Nagaizumi, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tochigi
    • Shimotsuke-city, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center
  • Daejeon, Korea, Republic of, 35015
    • Chungnam national university hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea - Seoul St. Mary's Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Seoul, Gyeonggi-do, Korea, Republic of, 03080
      • Seoul National University Hospital
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 41944
      • Kyungpook National University Hospital
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital
  • Gyeongsangnam-do
    • Busan, Gyeongsangnam-do, Korea, Republic of, 49241
      • Pusan National University Hospital
• Mexico
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
• Norway
  • Oslo, Norway, 0372
    • Oslo University Hospital - Rikshospitalet
• Poland
  • Pomorskie
    • Gdansk, Pomorskie, Poland, 80-214
      • Uniwersyteckie Centrum Kliniczne
• Portugal
  • Lisboa, Portugal, 1099-023
    • Instituto Português de Oncologia de Lisboa Francisco Gentil
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto Francisco Gentil
• Romania
  • Bucuresti, Romania, 022328
    • Institutul Clinic Fundeni
  • Mures
    • Târgu-Mureş, Mures, Romania, 540042
      • Spitalul Clinic Judetean de Urgenta Targu Mure
• Russian Federation
  • Moscow, Russian Federation, 125167
    • National Research Center for Hematology
  • Sverdlovsk
    • Ekaterinburg, Sverdlovsk, Russian Federation, 620102
      • Sverdlovsk Regional Clinical Hospital #1
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 188770
    • Raffles Hospital
  • Singapore, Singapore, 119228
    • National University Hospital
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de la Arrixaca
  • Murcia, Spain, 30008
    • Hospital General Universitario Morales Meseguer
  • Salamanca, Spain, 37007
    • Hospital Universitario De Salamanca
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
  • LAS Palmas
    • Las Palmas De Gran Canaria, LAS Palmas, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrin
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
• Sweden
  • Stockholm, Sweden, 141 86
    • Karolinska Universitetssjukhuset
  • Skane
    • Lund, Skane, Sweden, 221 85
      • Skanes Universitetssjukhus I Lund
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
  • Zurich, Switzerland, 8091
    • Universitätsspital Zürich
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11259
    • Koo Foundation Sun Yat-Sen Cancer Center
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital
  • Hualien
    • Hualien City, Hualien, Taiwan, 970
      • Buddhist Tzu Chi General Hospital
• United Kingdom
  • England
    • Liverpool, England, United Kingdom, L7 8XP
      • The Clatterbridge Cancer Centre NHS Foundation Trust
    • London, England, United Kingdom, EC1M 6BQ
      • Barts Health NHS Trust
    • London, England, United Kingdom, W12 0HS
      • Imperial College Healthcare NHS Trust
    • Sheffield, England, United Kingdom, S10 2JF
      • Sheffield Teaching Hospitals NHS Foundation Trust
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XW
      • Cardiff and Vale University Health Board
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham Comprehensive Cancer Center
  • California
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at University of California Los Angeles
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
    • Atlanta, Georgia, United States, 30322
      • Emory University - Winship Cancer Institute
    • Augusta, Georgia, United States, 30912
      • Augusta University Georgia Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Marlene and Stewart Greenebaum Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Boston Children's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center
    • New Hyde Park, New York, United States, 11040
      • Cohen Children's Medical Center
    • New York, New York, United States, 10021
      • Weill Cornell Medical College
    • New York, New York, United States, 10032
      • Columbia University Medical Center - The Columbia Center for Translational Immunology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Hospitals
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Richmond, Virginia, United States, 23298
      • Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must be >= 18 years of age and, in selected countries, adolescents aged 12 years and greater and weighing >=30 kilogram (kg) at time of randomization.
2. Must undergo deoxyribose nucleic acid (DNA)-based human leukocyte antigen (HLA) matching and be 8 of 8 or 7 of 8 HLA-matched (singe allele or antigen mismatch at HLA-A, -B, and -C, and HLA-DRB1 is allowable) unrelated hematopoietic stem cell transplantation (HSCT) from either peripheral blood or bone marrow stem cells for a hematologic malignancy or myeloproliferative disorder.
3. For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned.
4. Allo-HSCT eligible (meeting institutional criteria)-participants planned medical care should include aGvHD prophylaxis with a combination of calcineurin inhibitor (CNI) (cyclosporine [CYS] or tacrolimus [TAC]) and methotrexate (MTX) or CNI and mycophenolate mofetil (MMF). With the exception of antithymocyte globulin (ATG) (antithymocyte globulin-Fresenius [ATG-F] or thymoglobulin), all other therapies, approved or investigational, for GvHD prophylaxis are excluded.
5. Eastern Cooperative Oncology Group (ECOG) performance status of <= 2 for participants aged >=18 years at randomization or >=60 % using the Karnofsky performance status for adolescent participants aged >=16 years at randomization or the Lansky performance status for adolescent participants aged 12 to < 16 years at randomization.

Exclusion Criteria:

1. Had prior allo- HSCT.
2. Planned umbilical cord blood transplant or planned to receive posttransplant cyclophosphamide, in vivo or ex vivo T cell-depleted hematopoietic stem cells (HSCs) with the exception of ATG (ATG-F or thymoglobulin).
3. Planned allo-HSCT for nonmalignant hematological disorders (example, aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Vedolizumab placebo-matching, intravenous (IV) infusion, once on Day -1 along with background graft-versus-host disease (GvHD) prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).	Drug: Vedolizumab Placebo; Vedolizumab placebo-matching IV infusion.
Experimental: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once on Day -1 along with background GvHD prophylaxis regimen prior to Allo-HSCT and once on Days +13, +41, +69, +97, +125, and +153 post Allo-HSCT up to the end of study treatment (up to 182 days).	Drug: Vedolizumab; Vedolizumab IV infusion.; Other Names: MLN0002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal aGvHD-Free Survival After Allo-HSCT by +180 Days	Intestinal aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death, where an event is defined as death due to any cause or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria. Data was censored for participants who have not had the intestinal aGvHD event or died or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.	From the date of first dose of study drug to first documented intestinal aGvHD or death, whichever occurs first up to +180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal aGvHD-Free and Relapse-Free Survival	Intestinal aGvHD and Relapse Free Survival is the time from the date of first study drug administration (Day-1) to intestinal aGvHD event/death/relapse, where an event is defined as death or Stage 1-4 intestinal involvement per Acute Graft versus-Host Disease Clinical Stage criteria, or relapse. It will be censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo-HSCT whichever occurs first.	From the date of first dose of study drug to first documented intestinal aGvHD, death or relapse, whichever occurs first up to Day +180
Grade C-D aGvHD-Free Survival	Grade C-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to GvHD event/death, where an event is defined as Grade C-D aGvHD any organ involvement per International Bone Marrow Transplant Registry Database (IBMTR) Severity Index for aGvHD or death. It will be censored for participants who have not had the event or have had the event after pre-specified timing, eg, last contact or Day +180 after allo-HSCT whichever occurs first.	From the date of first dose of study drug to first documented Grade C-D aGvHD or death, whichever occurs first up to Day +180
Nonrelapse Mortality (NRM)	Non-relapse mortality is the time from the date of first study drug administration (Day-1) to death without occurrence of a relapse. Data was censored for participants who have not had the event or have had the event after pre-specified timing, e.g., last contact or Day +180 after allo HSCT whichever occurs first.	From the date of first dose of study drug to first documented death without relapse, up to Day +180
Overall Survival (OS)	Overall Survival by Days +180 is the time from the date of first study drug administration (Day-1) to death from any cause.	From the date of first dose of study drug to first documented death up to Day +180
Grade B-D aGvHD-Free Survival	Grade B-D aGvHD Free Survival is the time from the date of first study drug administration (Day-1) to aGvHD event or death, where an event is defined as death or grade B-D any organ involvement per IBMTR Severity Index for aGvHD.	From the date of first dose of study drug to first documented grade B-D aGvHD or death, whichever occurs first up to Day +180

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.
• Investigators: Study Director: Medical Director, Takeda

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): February 7, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: Vedolizumab-3035; 2018-002141-11 (EudraCT Number); JapicCTI-184221 (Registry Identifier: JapicCTI); U1111-1216-2319 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes