Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
8 other identifiers
interventional
383
29 countries
171
Brief Summary
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2015
Typical duration for phase_3
171 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedStudy Start
First participant enrolled
December 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2018
CompletedResults Posted
Study results publicly available
January 23, 2020
CompletedMay 25, 2022
May 1, 2022
2.4 years
November 19, 2015
May 29, 2019
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission at Week 52
Clinical remission is defined as a complete Mayo score ≤ 2 points and no individual subscore \> 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
Week 52
Secondary Outcomes (4)
Percentage of Participants Achieving Mucosal Healing at Week 52
Week 52
Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52
Baseline, Weeks 6 and 52
Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52
Weeks 6 and 52
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Week 52
Study Arms (3)
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
EXPERIMENTALParticipants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab SC, 108 mg, injection, Q2W and placebo-matching IV infusions, Q8W, starting at Week 6 up to approximately Week 50.
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
EXPERIMENTALParticipants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Maintenance Phase: Induction IV + Placebo
EXPERIMENTALParticipants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching subcutaneous (SC) injections, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W) starting at Week 6 up to approximately Week 50.
Interventions
Vedolizumab intravenous infusion
Vedolizumab intravenous infusion placebo
Vedolizumab subcutaneous injection
Vedolizumab subcutaneous injection placebo
Eligibility Criteria
You may qualify if:
- Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
- Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore ≥2)
- Evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
- Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists
You may not qualify if:
- Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
- Extensive colonic resection, subtotal or total colectomy.
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Prior exposure to investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment of underlying disease within 30 days or 5 half-lives of screening (whichever is longer).
- Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
- Prior exposure to vedolizumab
- Surgical intervention for UC required at any time during the study.
- History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia.
- Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- Active infections
- Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection, HIV or tuberculosis (active or latent), identified congenital or acquired immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen \[HBsAg\] negative and hepatitis B antibody positive) may, however, be included.
- History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (174)
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, 72204, United States
Rocky Mountain Clinical Research, LLC
Wheat Ridge, Colorado, 80033, United States
Middlesex Gastroenterology Associates
Middletown, Connecticut, 06457, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452, United States
Florida Center for Gastroenterology
Largo, Florida, 33777, United States
L & L Research Choices, Inc.
Miami, Florida, 33176, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, 30024, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 41017, United States
Research Concierge, LLC
Owensboro, Kentucky, 42303, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519, United States
Ehrhardt Clinical Research, LLC
Belton, Missouri, 64012, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, 45415, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Virginia Mason Seattle Main Clinic
Seattle, Washington, 98101, United States
Expertia S.A- Mautalen Salud e Investigacion
Ciudad Autonoma Buenos Aires, C1128AAE, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Melbourne, Victoria, 3181, Australia
Clinique Saint-Pierre
Ottignies, 1340, Belgium
AZ Delta
Roeselare, 8800, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, 74535-170, Brazil
HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio Do Janeiro, 21941-913, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
MHAT 'Avis Medica' OOD
Pleven, 5800, Bulgaria
MHAT - Silistra AD
Silistra, 7500, Bulgaria
MHAT "Hadzhi Dimitar", OOD
Sliven, 8800, Bulgaria
Second MHAT - Sofia AD
Sofia, 1202, Bulgaria
"City Clinic UMHAC" EOOD
Sofia, 1407, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431, Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia, 1527, Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000, Bulgaria
London Health Science Centre
London, Ontario, N6A 5A5, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, L4L 4Y7, Canada
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
Clinical Hospital Centre Rijeka
Rijeka, 51000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Ccbr-Synarc A/S
Brno, 60200, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
A-SHINE s.r.o.
Pilsen, 31200, Czechia
Ccbr-Synarc A/S
Prague, 13000, Czechia
Axon Clinical, s.r.o.
Prague, 182 00, Czechia
Odense Universitetshospital
Odense C, 5000, Denmark
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
EUGASTRO GmbH
Leipzig, Saxony, 04103, Germany
Krankenhaus Waldfriede e. V.
Berlin, 14163, Germany
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, 1125, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, 2143, Hungary
Karolina Korhaz-Rendelointezet
Mosonmagyaróvár, H-9200, Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Wolfson Medical Center
Holon, 58100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
Milan, 20157, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152, Italy
Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Sakura-shi, Chiba, Japan
Unknown Facility
Matsuyama, Ehime, Japan
Unknown Facility
Chikushino-shi, Fukuoka, Japan
Unknown Facility
Hiroshima, Hiroshima, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Nishinomiya-shi, Hyōgo, Japan
Unknown Facility
Takamatsu, Kagawa-ken, Japan
Unknown Facility
Kamakura-shi, Kanagawa, Japan
Unknown Facility
Okayama, Okayama-ken, Japan
Unknown Facility
Osaka, Osaka, Japan
Unknown Facility
Saga, Saga-ken, Japan
Unknown Facility
Ōtsu, Shiga, Japan
Unknown Facility
Hamamatsu, Shizuoka, Japan
Unknown Facility
Bunkyō City, Tokyo-To, Japan
Unknown Facility
Minatoku, Tokyo-To, Japan
Unknown Facility
Mitaka-shi, Tokyo-To, Japan
Unknown Facility
Shinjuku-ku, Tokyo-To, Japan
Unknown Facility
Wakayama, Wakayama, Japan
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Klaipeda Republican Hospital, Public Institution
Klaipėda, 92231, Lithuania
Vilnius University Hospital Santariskiu Clinic, Public Institution
Vilnius, LT-08661, Lithuania
Morales Vargas Centro de Investigacion, S.C.
León, Guanajuato, 37000, Mexico
iBiomed Guadalajara
Zapopan, Jalisco, 45030, Mexico
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Christus Muguerza Sur S.A. de C.V.
Monterrey, Nuevo León, 64908, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Sociedad de Metabolismo y Corazon S.C
Veracruz, 91910, Mexico
Academisch Medisch Centrum
Amsterdam, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht, 3318 AT, Netherlands
Maastricht University Medical Center
Maastricht, 6229 HX, Netherlands
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
Bialystok, 15-275, Poland
NZOZ Vitamed
Bydgoszcz, 85-079, Poland
SP CSK im. prof. K. Gibinskiego SUM
Katowice, 40-752, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009, Poland
SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
Lodz, 90-153, Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302, Poland
GASTROMED Sp. z o.o.
Lublin, 20-582, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-270, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, 00-632, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02-781, Poland
Nzoz Vivamed
Warsaw, 03-580, Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw, 53-114, Poland
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
Wroclaw, 53-333, Poland
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002, Romania
TSBIH "Territorial Clinical Hospital"
Krasnoyarsk, 660022, Russia
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
Moscow, 119333, Russia
SBEIHPE Novosibirsk State Medical University
Novosibirsk, 630091, Russia
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
Novosibirsk, 630117, Russia
BHI of Omsk region Clinical Oncology Dispensary
Omsk, 644013, Russia
SBEI HPE "Rostov State Medical University" of the MoH of the RF
Rostov-on-Don, 344022, Russia
SPb SBIH "City Hospital of Saint Martyr Elizaveta"
Saint Petersburg, 195257, Russia
LLC "RIAT SPb"
Saint Petersburg, 197373, Russia
SBIH of Yaroslavl region " Regional Clinical Hospital "
Yaroslavl, 150062, Russia
Clinical Center Zvezdara
Belgrade, 11000, Serbia
Clinical Center Bezanijska kosa
Belgrade, 11080, Serbia
Clinical Center Zemun
Belgrade, 11080, Serbia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 82606, Slovakia
KM Management spol. s r.o.
Nitra, 949 01, Slovakia
Gastro I, s.r.o.
Prešov, 080 01, Slovakia
Kyungpook National University Hospital
Daegu, 41944, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, 36164, Spain
Karolinska Universitetssjukhuset - Solna
Stockholm, 17176, Sweden
Danderyds Sjukhus AB
Stockholm, 18288, Sweden
Ankara University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Acibadem Fulya Hospital
Istanbul, 34349, Turkey (Türkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, 34899, Turkey (Türkiye)
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
Chernivtsi, 58002, Ukraine
SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
Dnipro, 49074, Ukraine
Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76008, Ukraine
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
Kharkiv, 61037, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, 61039, Ukraine
CI A.and O. Tropiny City Clinical Hospital
Kherson, 73000, Ukraine
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
Kyiv, 01103, Ukraine
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
Kyiv, 01601, Ukraine
CI Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
Uzhhorod, 88009, Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001, Ukraine
MCIC MC LLC Health Clinic
Vinnytsia, 21029, Ukraine
SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
Zaporizhzhia, 69104, Ukraine
Royal Devon and Exeter Hospital (Wonford)
Exeter, Devon, EX2 5DW, United Kingdom
Whipps Cross University Hospital
London, Greater London, E11 1NR, United Kingdom
Royal Free Hospital
London, Greater London, NW3 2QG, United Kingdom
Related Publications (3)
D'Haens G, Baert F, Danese S, Kobayashi T, Loftus EV Jr, Sandborn WJ, Dornic Q, Lindner D, Kisfalvi K, Marins EG, Vermeire S. Efficacy of vedolizumab during intravenous induction therapy in ulcerative colitis and Crohn's disease: post hoc analysis of patient-reported outcomes from the VISIBLE 1 and 2 studies. Eur J Gastroenterol Hepatol. 2024 Apr 1;36(4):404-415. doi: 10.1097/MEG.0000000000002728. Epub 2024 Feb 21.
PMID: 38417060DERIVEDKobayashi T, Ito H, Ashida T, Yokoyama T, Nagahori M, Inaba T, Shikamura M, Yamaguchi T, Hori T, Pinton P, Watanabe M, Hibi T. Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis. Intest Res. 2021 Oct;19(4):448-460. doi: 10.5217/ir.2020.00026. Epub 2020 Aug 18.
PMID: 32806876DERIVEDSandborn WJ, Baert F, Danese S, Krznaric Z, Kobayashi T, Yao X, Chen J, Rosario M, Bhatia S, Kisfalvi K, D'Haens G, Vermeire S. Efficacy and Safety of Vedolizumab Subcutaneous Formulation in a Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):562-572.e12. doi: 10.1053/j.gastro.2019.08.027. Epub 2019 Aug 28.
PMID: 31470005DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2015
First Posted
November 23, 2015
Study Start
December 18, 2015
Primary Completion
May 30, 2018
Study Completion
August 21, 2018
Last Updated
May 25, 2022
Results First Posted
January 23, 2020
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.