An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— FIGARO UC 303  

Official title:

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

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
• 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
• 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].

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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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