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Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vedolizumab 300 mg IV
Placebo IV
Vedolizumab 108 mg SC
Placebo SC
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Drug therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
  2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with an endoscopic subscore ≥2)
  3. Evidence of UC extending proximal to the rectum (≥15 cm of involved colon).
  4. Inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists

Exclusion Criteria:

  1. Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.
  2. Extensive colonic resection, subtotal or total colectomy.
  3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
  4. 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).
  5. Prior exposure to any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (whichever is longer).
  6. Prior exposure to vedolizumab
  7. Surgical intervention for UC required at any time during the study.
  8. History or evidence of adenomatous colonic polyps that have not been removed or has a history or evidence of colonic mucosal dysplasia.
  9. Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
  10. Active infections
  11. 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.
  12. History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating or neurodegenerative disease.

Sites / Locations

  • Arkansas Primary Care Clinic, PA
  • Rocky Mountain Clinical Research, LLC
  • Middlesex Gastroenterology Associates
  • Nature Coast Clinical Research, LLC
  • Florida Center for Gastroenterology
  • L & L Research Choices, Inc.
  • Gastroenterology Group of Naples
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology Associates
  • Gastroenterology Associates of Central Georgia
  • Atlanta Gastroenterology Specialists, PC
  • Cotton-O'Neil Clinical Research Center, Digestive Health
  • Tri-State Gastroenterology Associates
  • Research Concierge, LLC
  • Gastroenterology Associates, LLC
  • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
  • Clinical Research Institute of Michigan, LLC
  • Gastroenterology Associates of Western Michigan, P.L.C.
  • Ehrhardt Clinical Research, LLC
  • Long Island Clinical Research Associates
  • Premier Medical Group of the Hudson Valley, PC
  • Dayton Gastroenterology, Inc
  • Options Health Research
  • Gastro One
  • Vanderbilt University Medical Center
  • Tyler Research Institute, LLC
  • Gastroenterology Associates of Tidewater
  • Virginia Mason Seattle Main Clinic
  • Expertia S.A- Mautalen Salud e Investigacion
  • Concord Repatriation General Hospital
  • Nepean Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • The Alfred Hospital
  • Clinique Saint-Pierre
  • AZ Delta
  • University Clinical Centre of the Republic of Srpska
  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
  • UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  • Faculdade de Medicina do ABC
  • MHAT 'Avis Medica' OOD
  • MHAT - Silistra AD
  • MHAT "Hadzhi Dimitar", OOD
  • Second MHAT - Sofia AD
  • "City Clinic UMHAC" EOOD
  • UMHAT "Sv. Ivan Rilski", EAD
  • UMHAT 'Tsaritsa Yoanna - ISUL', EAD
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
  • London Health Science Centre
  • LHSC - Victoria Hospital
  • Toronto Digestive Disease Associates, Inc.
  • Clinical Hospital Centre Osijek
  • Clinical Hospital Centre Rijeka
  • Clinical Hospital Centre Zagreb
  • Clinical Hospital Dubrava
  • Ccbr-Synarc A/S
  • Hepato-Gastroenterologie HK, s.r.o.
  • A-SHINE s.r.o.
  • Ccbr-Synarc A/S
  • Axon Clinical, s.r.o.
  • Odense Universitetshospital
  • West Tallinn Central Hospital
  • Medizinische Hochschule Hannover
  • EUGASTRO GmbH
  • Krankenhaus Waldfriede e. V.
  • Obudai Egeszsegugyi Centrum Kft.
  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
  • Pest Megyei Flor Ferenc Korhaz
  • Karolina Korhaz-Rendelointezet
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Tolna Megyei Balassa Janos Korhaz
  • Wolfson Medical Center
  • Chaim Sheba Medical Center
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Istituto Clinico Humanitas
  • I.R.C.C.S Policlinico San Donato
  • Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
  • Azienda Ospedaliera di Padova
  • Azienda Ospedaliera San Camillo Forlanini
  • Policlinico Universitario Agostino Gemelli
  • Kyungpook National University Hospital
  • Yeungnam University Hospital
  • Kyung Hee University Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  • Klaipeda Republican Hospital, Public Institution
  • Vilnius University Hospital Santariskiu Clinic, Public Institution
  • Morales Vargas Centro de Investigacion, S.C.
  • iBiomed Guadalajara
  • Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Christus Muguerza Sur S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Sociedad de Metabolismo y Corazon S.C
  • Academisch Medisch Centrum
  • Albert Schweitzer Ziekenhuis, Dordwijk
  • Maastricht University Medical Center
  • SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
  • NZOZ Vitamed
  • SP CSK im. prof. K. Gibinskiego SUM
  • Gabinet Endoskopii Przewodu Pokarmowego
  • SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
  • Santa Familia Centrum Badan, Profilaktyki i Leczenia
  • GASTROMED Sp. z o.o.
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Centralny Szpital Kliniczny MSW w Warszawie
  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Nzoz Vivamed
  • LexMedica Osrodek Badan Klinicznych
  • Ars-Medica S.C Rybak Maria, Rybak Zbigniew
  • Spitalul Clinic Colentina
  • Institutul Clinic Fundeni
  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
  • TSBIH "Territorial Clinical Hospital"
  • FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
  • SBEIHPE Novosibirsk State Medical University
  • FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
  • BHI of Omsk region Clinical Oncology Dispensary
  • SBEI HPE "Rostov State Medical University" of the MoH of the RF
  • LLC "RIAT SPb"
  • SPb SBIH "City Hospital of Saint Martyr Elizaveta"
  • SBIH of Yaroslavl region " Regional Clinical Hospital "
  • Clinical Center Zvezdara
  • Clinical Center Bezanijska kosa
  • Clinical Center Zemun
  • Clinical Center Kragujevac
  • Clinical Center of Vojvodina
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • KM Management spol. s r.o.
  • Gastro I, s.r.o.
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Complejo Hospitalario de Pontevedra
  • Karolinska Universitetssjukhuset - Solna
  • Danderyds Sjukhus AB
  • Ankara University Medical Faculty
  • Acibadem Fulya Hospital
  • Marmara University Pendik Research and Training Hospital
  • RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
  • SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
  • Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
  • CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • CI A.and O. Tropiny City Clinical Hospital
  • Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
  • MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
  • CI Odesa Regional Clinical Hospital
  • SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
  • Private Small Enterprise Medical Center Pulse
  • MCIC MC LLC Health Clinic
  • SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
  • Royal Devon and Exeter Hospital (Wonford)
  • Whipps Cross University Hospital
  • Royal Free Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Maintenance Phase: Induction IV + Vedolizumab 108 mg SC

Maintenance Phase: Induction IV + Vedolizumab 300 mg IV

Maintenance Phase: Induction IV + Placebo

Arm Description

Participants 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.

Participants 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.

Participants 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percentage of Participants Achieving Mucosal Healing at Week 52
Mucosal healing is defined as Mayo endoscopic subscore ≤1 point. The findings on endoscopy scale ranges from 0 to 3, where 0=normal or inactive disease 1=mild disease (erythema, decreased vascular pattern, mild friability) 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3=severe disease (spontaneous bleeding, ulceration).
Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52
Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤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).
Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52
Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (≤) 2 points and no individual subscore greater than (>) 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).
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a complete Mayo score of ≤ 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).

Full Information

First Posted
November 19, 2015
Last Updated
May 2, 2022
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02611830
Brief Title
Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2015 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to treat people who have moderate to severely active ulcerative colitis. This study will look at clinical remission as well as mucosal healing, durable clinical response, durable clinical remission, and corticosteroid free remission in participants with UC who receive vedolizumab SC maintenance therapy after having achieved a clinical response to vedolizumab IV induction therapy. The study enrolled 383 patients. All participants will enter into a 6-week Induction Phase where they will be administered open-label vedolizumab IV 300 mg via intravenous infusion (IV) at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly assigned to one of the three treatment groups: Vedolizumab SC 108 mg Q2W and Placebo IV Q8W Vedolizumab IV 300 mg Q8W and Placebo SC Q2W Placebo SC Q2W and Placebo IV Q8W Participants who do not achieve a clinical response at Week 6 will not be randomized in to the Maintenance Period, and will receive a third infusion of vedolizumab IV 300 mg at Week 6. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 71 weeks (up to 4 weeks of screening, 52 weeks of treatment and 18 weeks of safety follow-up). Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug. After the Week 52 assessments, participants meeting protocol-defined criteria were eligible to enroll in Study MLN0002SC-3030 (NCT02620046; Long-term Safety) to receive open-label vedolizumab treatment. Participants who withdrew early (prior to Week 52) due to sustained nonresponse, disease worsening, or the need for rescue medications may also have been eligible for Study MLN0002SC-3030. Participants who did not enroll into Study MLN0002SC-3030 were to complete a final on-study safety assessment at Week 68 (or final safety visit 18 weeks after the last dose) in the Maintenance Phase of Study MLN0002SC-3027.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
383 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maintenance Phase: Induction IV + Vedolizumab 108 mg SC
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Maintenance Phase: Induction IV + Vedolizumab 300 mg IV
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Maintenance Phase: Induction IV + Placebo
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Vedolizumab 300 mg IV
Intervention Description
Vedolizumab intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Placebo IV
Intervention Description
Vedolizumab intravenous infusion placebo
Intervention Type
Drug
Intervention Name(s)
Vedolizumab 108 mg SC
Intervention Description
Vedolizumab subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo SC
Intervention Description
Vedolizumab subcutaneous injection placebo
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission at Week 52
Description
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).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Mucosal Healing at Week 52
Description
Mucosal healing is defined as Mayo endoscopic subscore ≤1 point. The findings on endoscopy scale ranges from 0 to 3, where 0=normal or inactive disease 1=mild disease (erythema, decreased vascular pattern, mild friability) 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3=severe disease (spontaneous bleeding, ulceration).
Time Frame
Week 52
Title
Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52
Description
Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤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).
Time Frame
Baseline, Weeks 6 and 52
Title
Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52
Description
Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (≤) 2 points and no individual subscore greater than (>) 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).
Time Frame
Weeks 6 and 52
Title
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Description
Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a complete Mayo score of ≤ 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).
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Primary Care Clinic, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Rocky Mountain Clinical Research, LLC
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Middlesex Gastroenterology Associates
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Nature Coast Clinical Research, LLC
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Florida Center for Gastroenterology
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
L & L Research Choices, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Atlanta Gastroenterology Specialists, PC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center, Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Tri-State Gastroenterology Associates
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Research Concierge, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, P.L.C.
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Ehrhardt Clinical Research, LLC
City
Belton
State/Province
Missouri
ZIP/Postal Code
64012
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Dayton Gastroenterology, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Options Health Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Virginia Mason Seattle Main Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Expertia S.A- Mautalen Salud e Investigacion
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1128AAE
Country
Argentina
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Clinique Saint-Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
AZ Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
City
Goiania
State/Province
Goias
ZIP/Postal Code
74535-170
Country
Brazil
Facility Name
HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
State/Province
Rio Do Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
MHAT 'Avis Medica' OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
MHAT - Silistra AD
City
Silistra
ZIP/Postal Code
7500
Country
Bulgaria
Facility Name
MHAT "Hadzhi Dimitar", OOD
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Second MHAT - Sofia AD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
"City Clinic UMHAC" EOOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Sv. Ivan Rilski", EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
London Health Science Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
LHSC - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Clinical Hospital Centre Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Clinical Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Ccbr-Synarc A/S
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
A-SHINE s.r.o.
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
Facility Name
Ccbr-Synarc A/S
City
Praha 3
ZIP/Postal Code
13000
Country
Czechia
Facility Name
Axon Clinical, s.r.o.
City
Praha 8
ZIP/Postal Code
182 00
Country
Czechia
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Krankenhaus Waldfriede e. V.
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Karolina Korhaz-Rendelointezet
City
Mosonmagyarovar
ZIP/Postal Code
H-9200
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Tolna Megyei Balassa Janos Korhaz
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
I.R.C.C.S Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Nagoya-shi
State/Province
Aichi-Ken
Country
Japan
City
Sakura-shi
State/Province
Chiba-Ken
Country
Japan
City
Matsuyama-shi
State/Province
Ehime-Ken
Country
Japan
City
Chikushino-shi
State/Province
Fukuoka-Ken
Country
Japan
City
Hiroshima-shi
State/Province
Hiroshima-Ken
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Nishinomiya-shi
State/Province
Hyogo-Ken
Country
Japan
City
Takamatsu-shi
State/Province
Kagawa-Ken
Country
Japan
City
Kamakura-shi
State/Province
Kanagawa-Ken
Country
Japan
City
Okayama-shi
State/Province
Okayama-Ken
Country
Japan
City
Osaka-shi
State/Province
Osaka-Fu
Country
Japan
City
Saga-shi
State/Province
Saga-Ken
Country
Japan
City
Otsu-shi
State/Province
Shiga-Ken
Country
Japan
City
Hamamatsu-shi
State/Province
Shizuoka-Ken
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo-To
Country
Japan
City
Minato-ku
State/Province
Tokyo-To
Country
Japan
City
Mitaka-shi
State/Province
Tokyo-To
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo-To
Country
Japan
City
Wakayama-shi
State/Province
Wakayama-Ken
Country
Japan
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Klaipeda Republican Hospital, Public Institution
City
Klaipeda
ZIP/Postal Code
92231
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Clinic, Public Institution
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Morales Vargas Centro de Investigacion, S.C.
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
iBiomed Guadalajara
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Christus Muguerza Sur S.A. de C.V.
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64908
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Sociedad de Metabolismo y Corazon S.C
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis, Dordwijk
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
City
Bialystok
ZIP/Postal Code
15-275
Country
Poland
Facility Name
NZOZ Vitamed
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
SP CSK im. prof. K. Gibinskiego SUM
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Gabinet Endoskopii Przewodu Pokarmowego
City
Krakow
ZIP/Postal Code
31-009
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Santa Familia Centrum Badan, Profilaktyki i Leczenia
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
GASTROMED Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-270
Country
Poland
Facility Name
Centrum Zdrowia Matki, Dziecka i Mlodziezy
City
Warszawa
ZIP/Postal Code
00-632
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Nzoz Vivamed
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
53-114
Country
Poland
Facility Name
Ars-Medica S.C Rybak Maria, Rybak Zbigniew
City
Wroclaw
ZIP/Postal Code
53-333
Country
Poland
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
TSBIH "Territorial Clinical Hospital"
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
SBEIHPE Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
BHI of Omsk region Clinical Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
SBEI HPE "Rostov State Medical University" of the MoH of the RF
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
LLC "RIAT SPb"
City
Saint-Petersburg
ZIP/Postal Code
197373
Country
Russian Federation
Facility Name
SPb SBIH "City Hospital of Saint Martyr Elizaveta"
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
SBIH of Yaroslavl region " Regional Clinical Hospital "
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Clinical Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Zemun
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center of Vojvodina
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
KM Management spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Gastro I, s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36164
Country
Spain
Facility Name
Karolinska Universitetssjukhuset - Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Danderyds Sjukhus AB
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Acibadem Fulya Hospital
City
Istanbul
ZIP/Postal Code
34349
Country
Turkey
Facility Name
Marmara University Pendik Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU
City
Dnipro
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
CI A.and O. Tropiny City Clinical Hospital
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU
City
Kyiv
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
CI Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
SI Divisional Clinical Hospital of Uzhgorod Station of ST&BA LZ Dep of Therapy SHEI Uzhgorod NU
City
Uzhgorod
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
Private Small Enterprise Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
MCIC MC LLC Health Clinic
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
City
Zaporizhzhia
ZIP/Postal Code
69104
Country
Ukraine
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/takeda/
Citations:
PubMed Identifier
32806876
Citation
Kobayashi 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.
Results Reference
derived
PubMed Identifier
31470005
Citation
Sandborn 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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

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