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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03290781
Other study ID # SHP647-303
Secondary ID 2017-000573-37
Status Completed
Phase Phase 3
First received
Last updated
Start date April 4, 2018
Est. completion date July 1, 2021

Study information

Verified date December 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 366
Est. completion date July 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years to 81 Years
Eligibility 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 (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study. - Participants must have completed the 12-week induction treatment period (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants must have achieved clinical response in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). Clinical response is defined as: i) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (>=) 1 point or a sub score for rectal bleeding less than or equal to (<=) 1 OR ii) A decrease from the induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time. Exclusion Criteria: - Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]). - Participants who are likely to require surgery for UC during the study period. - Participants are females who became pregnant during induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is [i.e,] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation. - 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, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures. - Participants who have a newly diagnosed malignancy or recurrence of malignancy (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). - Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [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. - 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. - Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 [NCT03259334] and SHP647-302 [NCT03259308]) and who are without a generally accepted course of treatment. - Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study. - Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 [NCT03259334] and SHP647-302 [NCT03259308]) during study SHP647-303 [NCT03290781].

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ontamalimab
Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).
Other:
Placebo
Participants will receive 1 mL of sterile aqueous buffered solution.

Locations

Country Name City State
Argentina Fundación Favaloro Buenos Aires
Argentina Hospital Privado Centro Médico de Córdoba Córdoba
Argentina Sanatorio 9 de Julio SA San Miguel De Tucumán
Australia Royal Adelaide Hospital Adelaide South Australia
Australia The Alfred Hospital Box Hill Victoria
Australia Concord Repatriation General Hospital Concord New South Wales
Australia Royal Brisbane & Women's Hospital Herston Queensland
Australia Liverpool Hospital Liverpool New South Wales
Australia St Vincents Hospital Melbourne - PPDS Melbourne Victoria
Australia Mater Hospital Brisbane South Brisbane Queensland
Austria LKH-Universitätsklinikum Klinikum Graz Graz Steiermark
Austria Klinikum Klagenfurt Am Woerthersee Klagenfurt am Wörthersee
Austria Salzburger Landeskliniken Salzburg
Austria Universitätsklinikum St. Pölten St. Pölten Saint Pölten
Austria A.ö. Krankenhaus der Barmherzigen Brüder St. Veit an der Glan Kärnten
Austria Klinikum Wels-Grieskirchen GmbH Wels
Austria Medizinische Universitat Wien (Medical University of Vienna) Wien
Belgium UZ Gent Gent Oost-Vlaanderen
Belgium AZ Groeninge Kortrijk West-Vlaanderen
Belgium UZ Gasthuisberg Leuven Vlaams Brabant
Belgium CHU Mouscron Mouscron
Bosnia and Herzegovina Clinical Center Banja Luka Banja Luka
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 Ruse
Bulgaria Medical Center-1-Sevlievo EOOD Sevlievo
Bulgaria Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD Sofia Sofia-Grad
Bulgaria Diagnostic and Consulting Center Aleksandrovska EOOD Sofia
Bulgaria Medical Center Convex EOOD Sofia
Bulgaria Medical Center Excelsior OOD - PPDS Sofia
Bulgaria Second Multiprofile Hospital for Active Treatment Sofia Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Sveta Anna Sofia Sofia-Grad
Bulgaria University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Sofia
Bulgaria Diagnostic Consultative Centre Mladost - M OOD Varna
Canada Toronto Digestive Disease Associates Inc Toronto Ontario
Canada Percuro Clinical Research LTD Victoria British Columbia
Colombia Servimed S.A.S Bucaramanga Santander
Colombia IPS Centro Médico Julián Coronel S.A.S. - PPDS Cali
Colombia Hospital Pablo Tobón Uribe Medellin Antioquia
Croatia Opca bolnica Bjelovar Bjelovar
Croatia Opca Bolnica Karlovac Karlovac Karlovacka Županija
Croatia Clinical Hospital Centre Osijek Osijek
Croatia University Hospital Centre Split Split
Croatia General Hospital Virovitica Virovitica
Croatia General County Hospital Vukovar and Croatian Veterans Hospital Vukovar
Croatia General Hospital Zadar Zadar
Croatia University Hospital Center Zagreb Zagreb Grad Zagreb
Czechia Hepato-Gastroenterologie HK, s. r. o. Hradec Králové Královéhradecký Kraj
Czechia PreventaMed s.r.o. Olomouc Olomoucký Kraj
Czechia Institut Klinicke A Experimentalni Mediciny Praha 4
Czechia ISCARE I.V.F. a.s. Praha 7
Czechia Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Usti nad Labem
Czechia Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice Ústi Nad Orlici
Estonia East Viru Central Hospital Kohta-Järve
Estonia OÜ LV Venter Parnu
Estonia West Tallinn Central Hospital Tallinn
Germany Universitätsklinikum der RWTH Aachen Aachen Nordrhein-Westfalen
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Gastroenterologische Facharztpraxis am Mexikoplatz Berlin-Zehlendorf
Germany Sana Klinikum Biberach Biberach an der Riss
Germany Universitätsklinikum Frankfurt Frankfurt
Germany Asklepios Westklinikum Hamburg Ggmbh Hamburg
Germany Universitatsklinikum Jena Jena Thüringen
Germany Universitatsklinikum Schleswig-Holstein Kiel Schleswig-Holstein
Germany Uniklinik Köln Köln Nordrhein-Westfalen
Germany Klinikum rechts der Isa der Technischen Universitaet Muenchen Munich
Germany Gastro Campus Research GbR Münster Nordrhein-Westfalen
Germany Universitätsklinikum Ulm Ulm Baden-Württemberg
Greece Ippokrateio General Hospital of Athens Athens Attiki
Greece University General Hospital of Patras Patras
Greece Euromedica - PPDS Thessaloniki
Greece Theageneio Anticancer Oncology Hospital of Thessaloniki Thessaloniki
Hungary Bekes Megyei Kozponti Korhaz Békéscsaba
Hungary ENDOMEDIX Kft. Budapest
Hungary Magyar Honvédség Egészségügyi Központ Budapest
Hungary Pannónia Magánorvosi Centrum Kft Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Bekes Megyei Kozponti Korhaz Gyula
Hungary Mohacsi Korhaz Mohacs
Hungary Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Székesfehérvár
Hungary Tolna Megyei Balassa János Kórház Szekszard
Hungary Csongrad Megyei Dr. Bugyi Istvan Korhaz Szentes
Hungary Jávorszky Ödön Kórház Vác
Hungary Csolnoky Ferenc Korhaz Veszprém
Ireland St Vincent's University Hospital Dublin
Israel Hadassah Medical Center - PPDS Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Nahariya
Israel Nazareth EMMS Hospital Nazareth
Israel Tel Aviv Sourasky Medical Center PPDS Tel Aviv
Israel Baruch Padeh Poriya Medical Center Tiberias
Italy Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi Bologna Emilia-Romagna
Italy Azienda Ospedaliera Mater Domini Di Catanzaro Catanzaro Calabria
Italy Azienda Ospedaliera Universitaria Careggi Firenze Toscana
Italy Azienda Ospedaliero Universitaria Di Modena Policlinico Modena Emilia-Romagna
Italy IRCCS Ospedale Sacro Cuore Don Calabria Negrar Veneto
Italy A.O.U. Maggiore della Carità Novara
Italy Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino Padova Veneto
Italy Fondazione IRCCS Policlinico San Matteo di Pavia Pavia
Italy Azienda Ospedaliera San Camillo Forlanini Roma Lazio
Italy Fondazione Policlinico Universitario A Gemelli Roma
Italy La Sapienza-Università di Roma-Policlinico Umberto I Roma
Italy Istituto Clinico Humanitas Rozzano (MI)
Italy Ospedale Casa Sollievo Della Sofferenza IRCCS San Giovanni Rotondo Puglia
Italy Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino
Italy Azienda Ospedaliera Ordine Mauriziano di Torino Torino
Japan Tokatsu Tsujinaka Hospital Abiko
Japan Kunimoto Hospital Asahikawa
Japan Shinbeppu Hospital Beppu Ôita
Japan Fukuoka University Chikushi Hospital Chikushino
Japan Nihonbashi Egawa Clinic Chuo-Ku Tokyo
Japan Hakodate Koseiin Hakodate Goryoukaku Hospital Hakodate
Japan Medical Corporation Aoyama Clinic Kobe-shi Hyôgo
Japan Yuai Memorial Hospital Koga
Japan Kawabe Clinic Koganei
Japan Dokkyo Medical University Saitama Medical Center Koshigaya Saitama
Japan Hidaka Coloproctology Clinic Kurume-shi
Japan Aizawa Hospital Matsumoto-shi
Japan Jikei University Hospital Minato-ku Tokyo
Japan Kitasato University Kitasato Institute Hospital Minato-ku Tokyo
Japan Aichi Medical University Hospital Nagakute
Japan Nishinomiya Municipal Central Hospital Nishinomiya
Japan Hyogo College of Medicine Nishinomiya-shi Hyôgo
Japan Ishida Clinic of IBD and Gastroenterology Oita
Japan Ome Municipal General Hospital Ome Tokyo
Japan Onomichi General Hospital Onomichi
Japan Chiinkai Dojima General & Gastroenterology Clinic Osaka
Japan Yodogawa Christian Hospital Osaka Ôsaka
Japan Kinshukai Infusion Clinic Osaka-shi
Japan Shiga University of Medical Science Hospital Otsu-Shi
Japan Sagamihara Kyodo Hospital Sagamihara Kanagawa
Japan Bellland General Hospital Sakai
Japan Toho University Sakura Medical Center Sakura
Japan Sapporo Higashi Tokushukai Hospital Sapporo
Japan Sapporo Medical University Hospital Sapporo Hokkaidô
Japan Sapporo Tokushukai Hospital Sapporo-shi
Japan Tohoku Rosai Hospital Sendai
Japan Dokkyo Medical University Hospital Shimotsuga-gun
Japan Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital Takatsuki
Japan Koukokukai Ebisu Clinic Tokyo
Korea, Republic of Inje University Haeundae Paik Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Kyungpook National University Hospital Daegu Daegu Gwang'yeogsi
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam Gyeonggido
Korea, Republic of Asan Medical Center - PPDS Seoul
Korea, Republic of Inje University Seoul Paik Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Samsung Medical Center PPDS Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System - PPDS Seoul
Korea, Republic of The Catholic University of Korea, St. Vincent's Hospital Suwon Gyeonggido
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju Gang'weondo
Lebanon Rafik Hariri University Hospital Beirut
Lebanon Hammoud Hospital University Medical Center Saida
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics Kaunas
Lithuania Vilnius City Clinical Hospital Vilnius
Lithuania Vilnius University Hospital Santaros Klinikos Vilnius
Mexico Centro de Investigación Médica Aguascalientes Aguascalientes
Mexico Phylasis Clinicas Research S. de R.L. de C.V. Cuautitlán Izcalli
Mexico Clinica de Higado y Gastroenterologia Integral, S.C. Cuernavaca Morelos
Mexico JM Research S.C Cuernavaca Morelos
Mexico Centro de Investigacion Clinica Acelerada, S.C. Distrito Federal
Mexico Instituto de Investigaciones Aplicadas a la Neurociencia A.C. Durango
Mexico Unidad de Atencion Medica e Investigacion en Salud Merida Yucatán
Mexico Accelerium, S. de R.L. de C.V. Monterrey
Mexico Clinical Research Institute Tlalnepantla De Baz
Mexico Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Zapopan
Netherlands NWZ, location Alkmaar Alkmaar Noord-Holland
Netherlands Academisch Medisch Centrum Amsterdam Amsterdam
Netherlands VU Medisch Centrum Amsterdam
Netherlands Leids Universitair Medisch Centrum Leiden Zuid-Holland
Netherlands ETZ-Elisabeth Tilburg Noord-Brabant
New Zealand Dunedin Hospital Dunedin South Island
New Zealand Auckland City Hospital Grafton Auckland
New Zealand Waikato Hospital Hamilton
New Zealand Wellington Hospital Newtown Wellington
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok Podlaskie
Poland Centrum Medyczne Pratia Bydgoszcz Bydgoszcz
Poland Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy Bydgoszcz
Poland Vitamed Galaj i Cichomski sp.j. Bydgoszcz Kujawsko-pomorskie
Poland Centrum Medyczne Czestochowa - PRATIA - PPDS Czestochowa
Poland Centrum Medyczne Gdynia - PRATIA - PPDS Gdynia
Poland BioVirtus Centrum Medyczne Jozefow Mazowieckie
Poland NZOZ All Medicus Katowice
Poland Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach Katowice Slaskie
Poland Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii Konskie Swietokrzyskie
Poland Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska Krakow
Poland Krakowskie Centrum Medyczne Krakow Malopolskie
Poland Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. Ksawerow
Poland Med Gastr Sp.z.o.o Sp.k Lodz
Poland Instytut Centrum Zdrowia Matki Polki Lódz Lódzkie
Poland Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny Lódz Lódzkie
Poland Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow Lódz Lódzkie
Poland Twoja Przychodnia - Centrum Medyczne Nowa Sol Nowa Sól
Poland Centrum Innowacyjnych Terapii Piaseczno
Poland Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia, Medic-R Spólka Komandytowa Poznan
Poland Korczowski Bartosz, Gabinet Lekarski Rzeszow
Poland Endoskopia Sp. z o.o. Sopot Pomorskie
Poland Bandurskiego 98/U12 Szczecin
Poland Sonomed Sp. z o.o. Szczecin
Poland Twoja Przychodnia - Szczecinskie Centrum Medyczne Szczecin Zachodniopomorskie
Poland Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj Torun Kujawsko-pomorskie
Poland H-T. Centrum Medyczne Endoterapia Tychy
Poland Centralny Szpital Kliniczny MSW Warszawa
Poland Centrum Medyczne Warszawa - PRATIA - PPDS Warszawa
Poland Centrum Zdrowia MDM Warszawa
Poland Miedzyleski Szpital Specjalistyczny w Warszawie Warszawa Mazowieckie
Poland Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Warszawa Mazowieckie
Poland Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Wloclawek Kujawsko-pomorskie
Poland Lexmedica Wroclaw Dolnoslaskie
Poland Melita Medical Wroclaw Dolnoslaskie
Poland Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II Zamosc
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar do Algarve - Hospital de Portimao Faro
Portugal Hospital Senhora da Oliveira - Guimaraes, E.P.E Guimarães
Portugal Hospital da Luz Lisbon Lisboa
Portugal Hospital de São Bernardo Setubal
Romania Colentina Clinical Hospital Bucharest
Romania Dr.Carol Davila Emergency University Central Military Hospital Bucharest
Romania Fundeni Clinical Institute Bucharest
Romania Prof. Dr. Matei Bals Institute of Infectious Diseases Bucharest
Romania Sana Monitoring SRL Bucharest
Romania Centrul Medical Hifu Terramed Conformal S.R.L. Bucuresti
Romania Cluj-Napoca Emergency Clinical County Hospital Cluj-Napoca Cluj
Romania Affidea Romania SRL Constanta
Romania Gastromedica SRL Iasi
Romania Dr. Tirnaveanu Amelita Private Practice Oradea
Romania Dr. Goldis Gastroenterology Center SRL Timisoara
Russian Federation Kazan State Medical University Kazan
Russian Federation Moscow Clinical Scientific Center Moscow
Russian Federation Moscow Regional Research Clinical Institute Na Mfvladimirskiy Moscow
Russian Federation Nizhegorodskaya Regional Clinical Hospital n.a. Semashko Nizhny Novgorod
Russian Federation Research Institute of Physiology and Basic Medicine Novosibirsk
Russian Federation Rostov State Medical University Rostov-on-Don
Russian Federation Rostov State Medical University Rostov-on-Don
Russian Federation Russian Medical Military Academy n.a. S.M. Kirov Saint Petersburg
Russian Federation Union Clinic, LLC Saint Petersburg
Russian Federation Medical Company Hepatolog, LLC Samara
Russian Federation Medical University Reaviz Samara
Russian Federation Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city Samara
Russian Federation SHI Regional Clinical Hospital Saratov
Russian Federation Smolensk Regional Clinical Hospital Smolensk
Russian Federation First St. Petersburg State Medical University n.a. I.P Pavlov St. Petersburg
Russian Federation St. Elizabeth Municipal Clinical Hospital St. Petersburg
Russian Federation Stavropol State Medical University Stavropol
Russian Federation Regional Consulting and Diagnostics Centre Tyumen
Serbia Clinical Hospital Center Bezanijska Kosa Belgrade
Serbia University Clinical Center Kragujevac Kragujevac Šumadijski Okrug
Serbia University Clinical Center Nis Nis
Serbia General Hospital Vrsac Vrsac
Slovakia Univerzitna nemocnica Bratislava Bratislava
Slovakia KM Management, spol. s r.o. Nitra
Slovakia Gastro LM, s.r.o. Presov
South Africa Dr JP Wright Claremont Western Cape
South Africa CLINRESCO, ARWYP Medical Suites Johannesburg Gauteng
South Africa Dr. J Breedt Pretoria Gauteng
Spain Centro Medico Teknon - Grupo Quironsalud Barcelona
Spain C.H. Regional Reina Sofia - PPDS Cordoba Córdoba
Spain Hospital Universitario de Fuenlabrada Fuenlabrada Madrid
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 Sevilla
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Spain CHUVI - H.U. Alvaro Cunqueiro Vigo Pontevedra
Switzerland Universität Zürich Zürich Zürich (de)
Turkey Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul
Turkey Mersin University Medical Faculty Mersin
Ukraine Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital" Chernivtsi Chernivets'ka Oblast
Ukraine LLC Medical Center Family Medicine Clinic Dnipro
Ukraine ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council 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 Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council Kharkiv Kharkivs'ka Oblast
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 Kyiv City Clinical Hospital #18 Kyiv
Ukraine Medical Center of LLC Medical Clinic Blagomed 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 Kyïv
Ukraine Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy" 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 Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1 Vinnytsia
Ukraine Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC Vinnytsia
Ukraine Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC Vinnytsia Vinnyts'ka Oblast
Ukraine Medical Clinical Research Center of Medical Center LLC Health Clinic Vinnytsia
Ukraine MNPE City Hospital No. 6 of Zaporizhzhia City Council Zaporizhzhia
Ukraine Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council Zaporizhzhia Zaporiz'ka Oblast
United Kingdom Aberdeen Royal Infirmary - PPDS Aberdeen Aberdeen City
United Kingdom Western General Hospital Edinburgh - PPDS Edinburh
United Kingdom Fairfield General Hospital - PPDS Lancashire Bury
United Kingdom Whipps Cross University Hospital London London, City Of
United Kingdom Royal Gwent Hospital - PPDS Newport
United Kingdom North Tyneside General Hospital North Shields Northumberland
United Kingdom Royal Shrewsbury Hospital Shrewsbury Shropshire
United Kingdom New Cross Hospital Wolverhampton
United States Advanced Research Center Anaheim California
United States University of Michigan Ann Arbor Michigan
United States Atlanta Gastroenterology Specialists, PC Atlanta Georgia
United States Infinite Clinical Trials Atlanta Georgia
United States Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS Baytown Texas
United States HP Clinical Research Bountiful Utah
United States Commonwealth Clinical Studies LLC Brockton Massachusetts
United States New York Total Medical Care PC Brooklyn New York
United States Renaissance Research Medical Group, INC Cape Coral Florida
United States Clinical Research Institute of Michigan Chesterfield Michigan
United States Chevy Chase Clinical Research Chevy Chase Maryland
United States Loretto Hospital Chicago Illinois
United States Consultants For Clinical Research Inc Cincinnati Ohio
United States Consultants For Clinical Research Inc Cincinnati Ohio
United States Gastro Florida Clearwater Florida
United States Asthma and Allergy Associates PC - CRN - PPDS Colorado Springs Colorado
United States Peak Gastroenterology Associates Colorado Springs Colorado
United States Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS Columbus Georgia
United States Advanced Clinical Research Network Coral Gables Florida
United States Alliance Medical Research LLC Coral Springs Florida
United States Kindred Medical Institute for Clinical Trials, LLC Corona California
United States Northside Gastroenterology Cypress Texas
United States Atlanta Center For Gastroenterology PC Decatur Georgia
United States Mayo Clinic Health System - PPDS Duluth Minnesota
United States Exemplar Research, Inc. - Elkins Elkins West Virginia
United States United Medical Doctors Encinitas California
United States Medisphere Medical Research Center LLC Evansville Indiana
United States Consultants For Clinical Research Inc Fairfield Ohio
United States Prestige Clinical Research Franklin Ohio
United States Mid Atlantic Health Specialists Galax Virginia
United States Digestive Health Associates of Texas, P.A.dba DHAT Research Institute Garland Texas
United States Gastro One Germantown Tennessee
United States IL Gastroenterology Group Gurnee Illinois
United States National Clinical, LLC Hamtramck Michigan
United States Gastroenterology Associates of Hazard Hazard Kentucky
United States Edward Hines Jr VA Hospital - NAVREF - PPDS Hines Illinois
United States CroNOLA, LLC. Houma Louisiana
United States Aztec Medical Research Houston Texas
United States BI Research Center Houston Texas
United States Biopharma Informatic Inc. Houston Texas
United States Precision Research Institute, LLC Houston Texas
United States Southwest Clinical Trials Houston Texas
United States East Carolina Gastroenterology Jacksonville North Carolina
United States ENCORE Borland-Groover Clinical Research - ERN - PPDS Jacksonville Florida
United States SIH Research Kissimmee Florida
United States University of California San Diego La Jolla California
United States Clinical Trials of SWLA, LLC Lake Charles Louisiana
United States NYU Langone Long Island Clinical Research Associates Lake Success New York
United States OM Research LLC - Lancaster - ClinEdge - PPDS Lancaster California
United States Advanced Biomedical Research of America Las Vegas Nevada
United States Atria Clinical Research - Clinedge - PPDS Little Rock Arkansas
United States VA Long Beach Healthcare System - NAVREF - PPDS Long Beach California
United States Ohio Clinical Research Partners LLC Mentor Ohio
United States Arizona Digestive Health Mesa - East Mesa Arizona
United States Hi Tech and Global Research, LLc Miami Florida
United States Nuren Medical and Research Center Miami Florida
United States Sanchez Clinical Research, Inc Miami Florida
United States Crystal Biomedical Research Miami Lakes Florida
United States Laporte County Institute For Clinical Research Michigan City Indiana
United States Facey Medical Foundation Mission Hills California
United States West Virginia University Hospital Morgantown West Virginia
United States United Medical Doctors Murrieta California
United States Gastroenterology Group of Naples Naples Florida
United States Pharma Research International Inc Naples Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Weill Cornell Medical College New York New York
United States Encompass Care North Las Vegas Nevada
United States Dupage Medical Group Oakbrook Terrace Illinois
United States Digestive Health Center PA Ocean Springs Mississippi
United States Veteran's Research and Education Foundation - NAVREF - PPDS Oklahoma City Oklahoma
United States Southtowns Gastroenterology, PLLC Orchard Park New York
United States Omega Research Consultants LLC - Clinedge - PPDS Orlando Florida
United States Elite Clinical Studies - Phoenix - Clinedge - PPDS Phoenix Arizona
United States Accel Research Sites - St. Petersburg - ERN - PPDS Pinellas Park Florida
United States Veterans Research Foundation of Pittsburgh - NAVREF - PPDS Pittsburgh Pennsylvania
United States BRCR Medical Center, Inc Plantation Florida
United States Alliance Clinical Research-(Vestavia Hills) Poway California
United States Inland Empire Liver Foundation Rialto California
United States East Coast Institute for Research, LLC Saint Augustine Florida
United States St Louis Center For Clinical Research Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Southern Star Research Institute LLC San Antonio Texas
United States University of California San Francisco San Francisco California
United States Care Access Research, San Pablo San Pablo California
United States Louisiana Research Center LLC Shreveport Louisiana
United States Piedmont Healthcare Statesville North Carolina
United States CHI Franciscan Digestive Care Associates Tacoma Washington
United States DBC Research Tamarac Florida
United States Bayside Clinical Research - New Port Richey Tampa Florida
United States DM Clinical Research - ERN - PPDS Tomball Texas
United States Advanced Gastroenterology-Union City Union City Tennessee
United States Winchester Gastroenterology Associates Winchester Virginia
United States UMass Memorial Medical Center Worcester Massachusetts
United States Digestive Disease Associates Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Shire

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  Estonia,  Germany,  Greece,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Remission Based on Composite Score at Week 52 Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). At Week 52
Secondary Number of Participants With Endoscopic Remission at Week 52 Endoscopic remission was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score of mayo score ranged from 0 to 3, where 0=normal or inactive disease; 3=severe disease (spontaneous bleeding, ulceration). At Week 52
Secondary Number of Participants With Clinical Remission at Week 52 Clinical remission was defined by stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal; 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease. At Week 52
Secondary Number of Participants With Sustained Remission at Week 52 Sustained remission was defined as in remission at Week 52 visit, among participants who were in remission at the time of baseline. Remission was defined as a stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score and rectal bleeding sub-score of 0 and endoscopic sub-score of 0 or 1 (modified, excludes friability). Sub-scores were rectal bleeding (range: 0-3, where 0= no blood & 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease). At Week 52
Secondary Number of Participants With Clinical Response Based on Composite Score at Week 52 Clinical response was defined as a decrease from induction study baseline in the composite score of subject reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the sub-score for rectal bleeding >=1 point or a sub-score for rectal bleeding <= 1. Composite score consisted of Mayo score without the PGA sub-score and ranges from 0 to 9 points. Mayo score was a measure of UC disease activity, ranged from 0 -12 points and consisted of 4 sub-scores, each graded from 0 -3, higher scores indicating more severe disease. The rectal bleeding sub-scores ranges from 0-3, where 0= no blood & 3=blood alone passes and centrally read endoscopic sub-score ranges from 0-3, where 0= normal/inactive disease; 3= severe disease. At Week 52
Secondary Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52 Mucosal healing was defined by centrally read endoscopic sub-score 0 or 1 (modified, excludes friability) and centrally read Geboes score of <=2. The centrally read endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. Geboes score grading system, was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicates more severe disease. At Week 52
Secondary Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 Glucocorticoid-free clinical remission was defined as clinical remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit among participants using glucocorticoids at the baseline. Clinical remission was defined as stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline in stool frequency sub-score, and rectal bleeding sub-score of 0, at the Week 52 visit. The stool frequency sub-score ranges from 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal and rectal bleeding sub-score ranges from 0-3, where 0= no blood & 3=blood alone passes). At Week 52
Secondary Number of Participants With Glucocorticoid-free Remission at Week 52 Glucocorticoid-free remission was defined as remission in addition to not requiring any treatment with glucocorticoids for at least 4 weeks prior to the Week 52 visit, among participants using glucocorticoids at the baseline. Remission was defined as a composite score of participant-reported symptoms using daily e-diary and endoscopy, with stool frequency sub-score of 0 or 1 with at least a 1-point change from induction study baseline, and rectal bleeding sub-score of 0, and endoscopic sub-score of 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisting of the Mayo score without the PGA sub-score and ranges from 0 to 9 points. The stool frequency sub-score, rectal bleeding sub-score and endoscopic sub-score of mayo score ranges from 0 to 3 with higher scores indicating more severe disease. At Week 52
Secondary Number of Participants With Remission Based on Total Mayo Score at Week 52 Remission defined as a total mayo score of less than or equal to (<=) 2 with no individual sub-score (stool frequency, rectal bleeding, endoscopy [modified, excludes friability], and physician's global assessment) exceeding 1. The total mayo score ranges from 0 to 12 points and consisted of the following 4 sub-scores, each graded from 0 to 3 with higher scores indicating more severe disease: Sub-scores were rectal bleeding (range: 0 to 3, where 0=no blood seen and 3=blood alone passes), stool frequency (range: 0 to 3, where 0=normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0 to 3-higher score indicating the severe disease), and an endoscopic sub-score (range: 0 to 3, where 0=normal or inactive disease; 3=severe disease [spontaneous bleeding, ulceration]. At Week 52
Secondary Number of Participants With Clinical Remission Based on Both Rectal Bleeding and Stool Frequency Sub-scores of 0 Clinical remission was defined as both rectal bleeding and stool frequency sub-scores of 0. Rectal bleeding was assessed on a scale from 0-3, where 0: no blood seen, 1: streaks of blood with stool less than half time, 2: obvious blood or streaks of blood with stool most of the time, and 3: blood alone passes. Stool frequency was assessed on a scale from 0-3, where 0: normal number of stools for this participant, 1: 1 to 2 stools more than normal, 2: 3 to 4 stools more than normal, and 3: 5 or more stools more than normal. Higher scores indicated more severe disease. At Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary Number of Participants With Sustained Endoscopic Remission at Week 52 Sustained endoscopic remission was defined as in endoscopic remission at Week 52 visit among participants who were in endoscopic remission at the time of baseline. Endoscopic remission was defined as a centrally read endoscopic sub-score of 0 or 1 (modified, excludes friability). The centrally read endoscopic sub-score range from 0 to 3, where 0=normal or inactive disease; 3=severe disease. At Week 52
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAEs) An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational product. Number of participants with TEAEs were reported. From start of study drug administration up to follow-up (Week 64)
Secondary Number of Participants Who Developed Positive Antidrug Antibodies to Ontamalimab Antibody testing was conducted using an electro chemiluminescent signal method. Serum samples was analyzed for presence of antidrug antibodies to ontamalimab. Number of participants who developed positive results for ontamalimab were reported. At Week 12, 24, 36 and 52
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