Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

NCT ID: NCT03259308

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 279 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-05
• Study Completion Date: 2020-10-06

Brief Summary

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Detailed Description

27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ontamalimab 25 mg

Participants will receive 25 milligram (mg) of ontamalimab subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: DRUG

Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Ontamalimab 75 mg

Participants will receive 75 mg of ontamalimab SC injection using PFS on Week 0, Week 4 and Week 8.

Group Type: EXPERIMENTAL

Ontamalimab

Intervention Type: DRUG

Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Placebo

Participants will receive placebo matched to ontamalimab SC injection using PFS on Week 0, Week 4, and Week 8.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive 1 mL of sterile aqueous buffered solution.

Interventions

Ontamalimab

Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Intervention Type: DRUG

Placebo

Participants will receive 1 mL of sterile aqueous buffered solution.

Intervention Type: DRUG

Other Intervention Names

SHP647; PF- 00547659

Eligibility Criteria

Inclusion Criteria

• Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.

• Participants must be able to voluntarily provide written, signed, and dated informed consent and/or assent, as applicable, to participate in the study.
• Participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index (BMI) >=16.5 kilogram per square metre (kg/m^2).
• Participants must have a documented diagnosis of UC for >=3 months before screening. The following must be available in each participant's source documentation:

a. A biopsy report to confirm the histological diagnosis. b. A report documenting disease duration based upon prior colonoscopy. Note: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.

• Participants must have moderate to severe active UC, defined as a total Mayo score of >=6, including a centrally read endoscopic subscore >=2, rectal bleeding subscore >=1, and stool frequency subscore >=1 at baseline.
• Participants must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
• Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate [ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).
• Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
• Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential.

Exclusion Criteria

• Participants with indeterminate colitis, microscopic colitis, non-steroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of Crohn's disease.
• Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
• Participants with past medical history or presence of toxic megacolon.
• Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
• Participants at risk for colorectal cancer must have a colonoscopy performed during the screening period with results available within 10 days before the baseline visit, unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.

Participants at risk for colorectal cancer include, but are not limited to:

1. Participants with extensive colitis for >=8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >=10 years before screening, regardless of age.

2. Participants >=50 years of age at the time of signing of the informed consent form.

• Participants have had prior treatment with ontamalimab (formerly PF-00547659, SHP647).

• Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.

• Participants have received anti-TNF treatment within 60 days before baseline.

• Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline.

• Participants have received any nonbiologic treatment with immunomodulatory properties (other than their current background UC treatment) within 30 days before baseline.

• Participants have ever received anti-integrin/adhesion molecule treatment (example (eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule).
• Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA, within 14 days before screening endoscopic procedure.
• Participants have received leukocyte apheresis or selective lymphocyte, monocyte, or granulocyte apheresis or plasma exchange within 30 days before baseline.
• Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before baseline.
• Participants have received a live (attenuated) vaccine within 30 days before the baseline visit.
• Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis [Participants with C. difficile infection at screening may be allowed re-test after treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the participants to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit.
• Participants with abnormal chest x-ray findings at screening, such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy.
• Participants with evidence of active or latent infection with Mycobacterium TB or participants with this history who have not completed a generally accepted full course of treatment before randomization are excluded. All other participants must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin test or interferon gamma release assay (IGRA) performed.

Participants who have no history of previously diagnosed active or latent TB are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >=5 millimeter [mm] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening. If IGRA test cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor.

1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin (BCG) vaccination, but may be used for any participant. Documentation of IGRA product used and the test result must be in the participant's source documentation if performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube Test.

2. If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed. In participants with no history of treated active or latent TB, a positive test on repeat will exclude the participant. Participants with a history of active or latent TB infection must follow instructions for "Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met" in this criterion.

3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action). This consultation must be included in source documentation.

Results from a chest x-ray, taken within the 12 weeks before or during screening must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist.

Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met:

1. The participant has previously received an adequate course of treatment for either latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale where rates of primary multidrug TB resistance are <5%. Participants from regions with higher rates of primary multidrug TB resistance are excluded) or active (acceptable multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included in source documentation. Consultation with a pulmonary or infectious disease specialist to confirm adequate treatment (ie, participant would be acceptable for immunosuppressant [eg, anti-TNF] treatment without additional action) must be performed during the screening period. The consultation report must be included in source documentation prior to enrollment.

2. A chest x-ray performed within 12 weeks before screening or during screening indicates no evidence of active or recurrent disease, and documentation of interpretation by a qualified medical specialist must be included in source documentation.

• Participants with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening.
• Participants with any unexplained symptoms suggestive of progressive multifocal leukoencephalopathy (PML) based on the targeted neurological assessment during the screening period.
• Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
• Participants with a significant concurrent medical condition at the time of screening or baseline, including, but not limited to, the following:

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1. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment will substantially increase the risk to the participant if he or she participates in the study.

2. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).

3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening.

4. History of significant cerebrovascular disease within 24 weeks before screening.

• Participants who have had significant trauma or major surgery within 4 weeks before the screening visit, or with any major elective surgery scheduled to occur during the study.

• Participants with evidence of cirrhosis with or without decompensation.

• Participants with primary sclerosing cholangitis.

• Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).

Note: If a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if no presence of hepatitis B virus (HBV) DNA is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in the central laboratory.

• Participants with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb] and HCVRNA).

Note: Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCVRNA at least 12 weeks prior to baseline]).

• Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during screening.

Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once during the screening period for confirmation. Results must be reviewed for eligibility prior to the screening endoscopy procedure.

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1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0×upper limit of normal (ULN).

2. Total bilirubin level >=1.5×ULN or >2.0×ULN if the participant has a known documented history of Gilbert's syndrome.

3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).

4. Platelet count <=100×10^9 per liter (/L) (100,000 cells per cubic millimeter [mm^3]) or >=1000×10^9/L (1,000,000 cells/mm^3).

5. White blood cell count <=3.5×10^9/L (3500 cells/mm^3).

• Absolute neutrophil count (ANC)<2×10^9/L (2000 cells/mm^3).

• Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 ml/min/1.73m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.

Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.

• Participants with known human immunodeficiency virus (HIV) infection based on documented history, with positive serological test, or positive HIV serologic test at screening, tested at the site's local laboratory in accordance with country requirements or tested at the central laboratory.

Note: A documented negative HIV test within 6 months of screening is acceptable and does not need to be repeated.

• Participants who have, or who have a history of (within 2 years before screening), serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of any kind, including abuse of medical marijuana (cannabis).

• Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

• Female participants who are planning to become pregnant during the study period.
• Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
• Participants who are investigational site staff members or relatives of those site staff members or Participants who are Shire employees directly involved in the conduct of the study.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Shire

Locations

Arizona Digestive Health Mesa - East

Mesa, Arizona, United States

Elite Clinical Studies - Phoenix - Clinedge - PPDS

Phoenix, Arizona, United States

Advanced Research Center

Anaheim, California, United States

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, United States

United Medical Doctors

Encinitas, California, United States

University of California San Diego

La Jolla, California, United States

VA Long Beach Healthcare System - NAVREF - PPDS

Long Beach, California, United States

Facey Medical Foundation

Mission Hills, California, United States

United Medical Doctors

Murrieta, California, United States

Alliance Clinical Research-(Vestavia Hills)

Poway, California, United States

University of California San Francisco

San Francisco, California, United States

Care Access Research, San Pablo

San Pablo, California, United States

Renaissance Research Medical Group, INC

Cape Coral, Florida, United States

Gastro Florida

Clearwater, Florida, United States

Hi Tech and Global Research, LLc

Coral Gables, Florida, United States

ENCORE Borland-Groover Clinical Research - ERN - PPDS

Jacksonville, Florida, United States

SIH Research

Kissimmee, Florida, United States

Alliance Medical Research LLC

Lighthouse PT, Florida, United States

Sanchez Clinical Research, Inc

Miami, Florida, United States

Crystal Biomedical Research

Miami Lakes, Florida, United States

Pharma Research International Inc

Naples, Florida, United States

Bayside Clinical Research - New Port Richey

New Port Richey, Florida, United States

Accel Research Sites - St. Petersburg - ERN - PPDS

Pinellas Park, Florida, United States

BRCR Medical Center Inc.

Plantation, Florida, United States

DBC Research

Tamarac, Florida, United States

Infinite Clinical Trials

Atlanta, Georgia, United States

Atlanta Center For Gastroenterology PC

Decatur, Georgia, United States

Atlanta Gastroenterology Specialists, PC

Suwanee, Georgia, United States

Loretto Hospital

Chicago, Illinois, United States

IL Gastroenterology Group

Gurnee, Illinois, United States

Edward Hines Jr VA Hospital - NAVREF - PPDS

Hines, Illinois, United States

Dupage Medical Group

Oakbrook Terrace, Illinois, United States

Gastroenterology Associates of Hazard

Hazard, Kentucky, United States

CroNOLA, LLC.

Houma, Louisiana, United States

Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Commonwealth Clinical Studies LLC

Brockton, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

National Clinical, LLC

Hamtramck, Michigan, United States

Washington University in St. Louis

St Louis, Missouri, United States

St Louis Center For Clinical Research

St Louis, Missouri, United States

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Encompass Care

North Las Vegas, Nevada, United States

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, United States

Weill Cornell Medical College

New York, New York, United States

Southtowns Gastroenterology, PLLC

Orchard Park, New York, United States

East Carolina Gastroenterology

Jacksonville, North Carolina, United States

Prestige Clinical Research

Franklin, Ohio, United States

Ohio Clinical Research Partners LLC

Mentor, Ohio, United States

Veteran's Research and Education Foundation - NAVREF - PPDS

Oklahoma City, Oklahoma, United States

Veterans Research Foundation of Pittsburgh - NAVREF - PPDS

Pittsburgh, Pennsylvania, United States

Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

Garland, Texas, United States

Precision Research Institute, LLC

Houston, Texas, United States

Biopharma Informatic Inc.

Houston, Texas, United States

Southwest Clinical Trials

Houston, Texas, United States

Aztec Medical Research

Houston, Texas, United States

BI Research Center

Houston, Texas, United States

Southern Star Research Institute LLC

San Antonio, Texas, United States

Mid Atlantic Health Specialists

Galax, Virginia, United States

Winchester Gastroenterology Associates

Winchester, Virginia, United States

Mayo Clinic Health System - PPDS

La Crosse, Wisconsin, United States

Sanatorio 9 de Julio SA

San Miguel de Tucumán, Tucumán Province, Argentina

Fundación Favaloro

Buenos Aires, , Argentina

Hospital Privado Centro Médico de Córdoba

Córdoba, , Argentina

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

UZ Gasthuisberg

Leuven, Vlaams Brabant, Belgium

AZ Groeninge

Kortrijk, West-Vlaanderen, Belgium

CHU Mouscron

Mouscron, , Belgium

Clinical Center Banja Luka

Banja Luka, , Bosnia and Herzegovina

Second Multiprofile Hospital for Active Treatment Sofia

Sofia, Sofia-Grad, Bulgaria

Diagnostic and Consulting Center Aleksandrovska EOOD

Sofia, Sofia-Grad, Bulgaria

University Multiprofile Hospital for Active Treatment Sveta Anna

Sofia, Sofia-Grad, Bulgaria

Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD

Sofia, Sofia-Grad, Bulgaria

University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD

Pleven, , Bulgaria

Multiprofile Hospital for Active Treatment Eurohospital

Plovdiv, , Bulgaria

Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS

Rousse, , Bulgaria

Medical Center-1-Sevlievo EOOD

Sevlievo, , Bulgaria

Medical Center Excelsior OOD - PPDS

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

Sofia, , Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, , Bulgaria

Medical Center Convex EOOD

Sofia, , Bulgaria

Diagnostic Consultative Centre Mladost - M OOD

Varna, , Bulgaria

Percuro Clinical Research LTD

Victoria, British Columbia, Canada

Toronto Digestive Disease Associates Inc

Toronto, Ontario, Canada

Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia

Fundación Clínica Shaio

Bogota, Cundinamarca, Colombia

Servimed S.A.S

Bucaramanga, Santander Department, Colombia

IPS Centro Médico Julián Coronel S.A.S. - PPDS

Cali, , Colombia

East Viru Central Hospital

Kohta-Järve, , Estonia

OÜ LV Venter

Pärnu, , Estonia

West Tallinn Central Hospital

Tallinn, , Estonia

Ippokrateio General Hospital of Athens

Athens, Attica, Greece

University General Hospital of Patras

Pátrai, , Greece

Theageneio Anticancer Oncology Hospital of Thessaloniki

Thessaloniki, , Greece

Euromedica - PPDS

Thessaloniki, , Greece

Bekes Megyei Kozponti Korhaz

Békéscsaba, , Hungary

Magyar Honvédség Egészségügyi Központ

Budapest, , Hungary

Pannónia Magánorvosi Centrum Kft

Budapest, , Hungary

ENDOMEDIX Kft.

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Bekes Megyei Kozponti Korhaz

Gyula, , Hungary

Mohacsi Korhaz

Mohács, , Hungary

Tolna Megyei Balassa János Kórház

Szekszárd, , Hungary

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , Hungary

Jávorszky Ödön Kórház

Vác, , Hungary

Csolnoky Ferenc Korhaz

Veszprém, , Hungary

St Vincent's University Hospital

Dublin, , Ireland

Sapporo Medical University Hospital

Sapporo, Hokkaidô, Japan

Medical Corporation Aoyama Clinic

Kobe, Hyôgo, Japan

Hyogo College of Medicine

Nishinomiya-shi, Hyôgo, Japan

Kunimoto Hospital

Asahikawa, , Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, , Japan

Aizawa Hospital

Matsumoto-shi, , Japan

Chiinkai Dojima General & Gastroenterology Clinic

Osaka, , Japan

Kinshukai Infusion Clinic

Osaka, , Japan

Yodogawa Christian Hospital

Osaka, , Japan

Ishida Clinic of IBD and Gastroenterology

Ōita, , Japan

Bellland General Hospital

Sakai, , Japan

Toho University Sakura Medical Center

Sakura, , Japan

Tohoku Rosai Hospital

Sendai, , Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, , Japan

Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital

Takatsuki, , Japan

Nihonbashi Egawa Clinic

Tokyo, , Japan

Koukokukai Ebisu Clinic

Tokyo, , Japan

Rafik Hariri University Hospital

Beirut, , Lebanon

Hammoud Hospital University Medical Center

Saida, , Lebanon

Health Pharma Professional Research S.A de C.V.

Mexico City, Mexico City, Mexico

Clinica de Higado y Gastroenterologia Integral, S.C.

Cuernavaca, Morelos, Mexico

JM Research S.C

Cuernavaca, Morelos, Mexico

Unidad de Atencion Medica e Investigacion en Salud

Mérida, Yucatán, Mexico

Centro de Investigación Médica Aguascalientes

Aguascalientes, , Mexico

Phylasis Clinicas Research S. de R.L. de C.V.

Cuautitlán Izcalli, , Mexico

Centro de Investigacion Clinica Acelerada, S.C.

Distrito Federal, , Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, , Mexico

Accelerium, S. de R.L. de C.V.

Monterrey, , Mexico

Clinical Research Institute

Tlalnepantla, , Mexico

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Zapopan, Jalisco, , Mexico

Auckland City Hospital

Grafton, Auckland, New Zealand

Dunedin Hospital

Dunedin, South Island, New Zealand

Wellington Hospital

Newtown, Wellington Region, New Zealand

Waikato Hospital

Hamilton, , New Zealand

Hospital de Braga

Braga, , Portugal

Hospital Senhora da Oliveira - Guimaraes, E.P.E

Guimarães, , Portugal

Hospital da Luz

Lisbon, , Portugal

Centro Hospitalar do Algarve - Hospital de Portimao

Portimão, , Portugal

Hospital de São Bernardo

Setúbal, , Portugal

Univerzitna nemocnica Bratislava

Bratislava, , Slovakia

KM Management, spol. s r.o.

Nitra, , Slovakia

Gastro LM, s.r.o.

Prešov, , Slovakia

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gang'weondo, South Korea

CHA Bundang Medical Center, CHA University

Seongnam, Gyeonggido, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggido, South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Yeungnam University Hospital

Daegu, , South Korea

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, , South Korea

Asan Medical Center - PPDS

Seoul, , South Korea

Samsung Medical Center PPDS

Seoul, , South Korea

Inje University Seoul Paik Hospital

Seoul, , South Korea

C.H. Regional Reina Sofia - PPDS

Córdoba, Córdoba, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

CHUVI - H.U. Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Centro Medico Teknon - Grupo Quironsalud

Barcelona, , Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario La Paz - PPDS

Madrid, , Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Universität Zürich

Zurich, Zürich (de), Switzerland

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"

Chernivtsi, Chernivtsi Oblast, Ukraine

Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Municipal Nonprofit Enterprise Vinnytsia City Clinical Hospital #1

Vinnytsia, Vinnytsia Oblast, Ukraine

Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

Vinnytsia, Vinnytsia Oblast, Ukraine

ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

Dnipro, , Ukraine

LLC Medical Center Family Medicine Clinic

Dnipro, , Ukraine

State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

Dnipro, , Ukraine

Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine

Kharkiv, , Ukraine

Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital

Kharkiv, , Ukraine

MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

Kharkiv, , Ukraine

Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

Kherson, , Ukraine

Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council

Kryvyi Rih, , Ukraine

Medical Center of LLC Medical Clinic Blagomed

Kyiv, , Ukraine

Kyiv City Clinical Hospital #18

Kyiv, , Ukraine

Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"

Kyiv, , Ukraine

Municipal Institution of KRC Kyiv Regional Hospital #2

Kyiv, , Ukraine

Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway

Lviv, , Ukraine

Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital

Lviv, , Ukraine

Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

Odesa, , Ukraine

MNPE Central City Clinical Hospital of Uzhhorod City Council

Uzhhorod, , Ukraine

Medical Clinical Research Center of Medical Center LLC Health Clinic

Vinnytsia, , Ukraine

Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC

Vinnytsia, , Ukraine

City Clinical Hospital #1

Vinnytsia, , Ukraine

Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"

Vinnytsia, , Ukraine

Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council

Zaporizhzhia, , Ukraine

MNPE City Hospital No. 6 of Zaporizhzhia City Council

Zaporizhzhia, , Ukraine

Countries

United States; Argentina; Belgium; Bosnia and Herzegovina; Bulgaria; Canada; Colombia; Estonia; Greece; Hungary; Ireland; Japan; Lebanon; Mexico; New Zealand; Portugal; Slovakia; South Korea; Spain; Switzerland; Turkey (Türkiye); Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b5fde4db2bf003ab4741c

To obtain more information on the study, click here/on this link

Other Identifiers

2017-000572-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SHP647-302

Identifier Type: -

Identifier Source: org_study_id