Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Crohn Disease Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02596893
• Other study ID #: GED-0301-CD-002
• Status: Terminated
• Phase: Phase 3
• Start date: December 8, 2015
• Est. completion date: January 5, 2018

Study information

• Verified date: August 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 701
• Est. completion date: January 5, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

• Male or female = 18 years

• Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)

• Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period

• Subject must have failed or experienced intolerance to at least one of the following:

budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

• Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis

• Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy

• Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit

• Ileostomy or a colostomy

• Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• GED-0301

• Placebo

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Ballarat Base Hospital	Ballarat
Australia	Bankstown-Lidcombe Hospital	Bankstown	Australian Capital Territory
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Monash Medical Centre Clayton	Bentleigh East
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St Vincents Hospital Melbourne	Fitzroy
Australia	Centre For Digestive Diseases	Five Dock	New South Wales
Australia	Austin Hospital	Heidelberg
Australia	Royal Brisbane and Women's Hospital	Herston
Australia	Nepean Hospital	Kingswood, NSW
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	LKH Universitaetsklinikum Graz	Graz
Austria	Medizinische Universitat Innsbruck	Innsbruck
Austria	Klinikum Klagenfurt am Wörtersee	Klagenfurt
Austria	KH der Barmherzigen Bruder Linz	Linz
Austria	a.o.Krankenhaus d.Barmherz.Schwestern Ried	Ried I Innkreis
Austria	LKH - Universitätsklinikum der PMU Salzburg	Salzburg
Austria	Ordination Dr. Thomas Haas Darmpraxis Salzburg	Salzburg
Austria	KH der Barmherzigen Brüder St.Veit an der Glan	St Veit An Der Glan
Austria	AKH Medizinische Universitat Wien	Wein
Austria	Krankenanstalt Rudolfstiftung Wien	Wein
Belgium	Universitair Ziekenhuis Brussel	Brussels
Belgium	Cliniques Universitaires St Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHU Sart Tilman	Liege
Belgium	Centre Hospitalier de Mouscron	Mouscron
Bulgaria	MHAT Sv Nikolay Chudotvorets EOOD	Lom
Bulgaria	MHAT Kaspela EOOD	Plovdiv
Bulgaria	MHAT Ruse AD	Ruse
Bulgaria	City Clinic UMHAC EOOD	Sofia
Bulgaria	Fourth MHAT Sofia EAD	Sofia
Bulgaria	MHAT Doverie AD	Sofia
Bulgaria	Second MHAT Sofia AD	Sofia
Bulgaria	UMHAT Sv Ivan Rilski EAD	Sofia
Bulgaria	UMHAT Tsaritsa Yoanna - ISUL EAD	Sofia
Canada	Barrie GI Associates	Barrie	Ontario
Canada	Brandon Medical Arts Clinic	Brandon	Manitoba
Canada	University of Calgary	Calgary	Alberta
Canada	GI Research Institute	Edmonton	Alberta
Canada	South Edmonton Gastroenterology	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Centre de sante et de services sociaux Champlain Charles Le Moyne	Greenfield Park	Quebec
Canada	McMaster University Health Sciences Center	Hamilton	Ontario
Canada	LHSC Victoria Hospital	London	Ontario
Canada	London Health Science Center U. Hospital	London	Ontario
Canada	CHUM Hôpital Saint-Luc	Montreal	Quebec
Canada	Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal	Montreal	Quebec
Canada	McGill University Health Centre Glen Site Royal Victoria Hospital	Montreal	Quebec
Canada	Recherche GCP Research	Montreal	Quebec
Canada	Montfort Hospital	Ottawa	Ontario
Canada	Recherche Clinique Sigma Inc	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	CHUS Hopital Fleurimont	Sherbrooke	Quebec
Canada	Recherche Medicale St Jerome Inc	St Jerome	Quebec
Canada	Humber River Hospital	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Toronto Liver Centre	Toronto	Ontario
Canada	GI Research Institute	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Toronto Digestive Disease Associates Inc	Vaughan	Ontario
Canada	PerCuro Clinical Research	Victoria	British Columbia
Canada	Medicine Professional Corporation	Waterloo	Ontario
Canada	Tarabain Osman MD	Windsor	Ontario
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	Clinical Hospital Centre Rijeka	Rijeka
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Croatia	Clinical Hospital Dubrava	Zagreb
Croatia	Clinical Hospital Merkur	Zagreb
Croatia	Clinical Hospital Sveti Duh	Zagreb
Czechia	Fakultni nemocnice u sv Anny v Brne	Brno
Czechia	Hepato-Gastroenterologie HK	Hradec Kralove
Czechia	Soukroma Gastroenterologicka ambulance a endoskopie	Most
Czechia	PreventaMed	Olomouc
Czechia	CCBR Czech as	Pardubice
Czechia	CCBR Prague CZ	Praha 3
Czechia	IBD Centrum ISCARE IVF as	Praha 7
Czechia	Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La	Usti nad Labem
Czechia	Nemocnice Znojmo	Znojmo
Denmark	Aarhus Universitetshospital	Aahus C
Denmark	Alborg University Hospital	Ålborg
Denmark	Nordsjaellands Hospital Frederikssund	Frederikssund
Denmark	Herlev Hospital	Herlev
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Koge Sygehus	Koge
Denmark	Regionshospitalet Silkeborg	Silkeborg
Estonia	West Tallinn Central Hospital	Tallinn
Estonia	Tartu University Hospital	Tartu
Finland	Tampereen yliopistollinen sairaala	Tampere
Finland	Turunmaan sairaala	Turku
France	CHU Amiens Hopital Sud	Amiens Cedex
France	CHU Besancon Hopital Jean Minjoz	Besancon Cedex
France	CHU Tours Hopital Trousseau	Chambray les Tours
France	CHU Clermont Ferrand	Clermont-Ferrand
France	Hopital Beaujon	Clichy cedex
France	CHU Dijon - Hopital Bocage Central	Dijon
France	CHU de Grenoble Hopital Nord	Grenoble cedex 9
France	Groupement Hospitalier Sud Hopital Bicetre	Le Kremlin Bicetre cedex
France	Hopital Claude Huriez CHRU Lille	Lille cedex
France	Hopital Nord	Marseille cedex 20
France	CHU Nantes Hotel Dieu	Nantes Cedex 1
France	CHU Nice Hopital de lArchet 2	Nice Cedex 3
France	Hopital Saint Antoine	Paris
France	Hopital Saint Louis	Paris
France	Groupe Hospitalier Sud Hopital Haut Leveque USN	Pessac
France	Centre Hospitalier Lyon Sud	Pierre-Bénite Cedex
France	CHU Reims Hopital Robert Debre	Reims
France	CHU Rennes Hopital Pontchaillou	Rennes cedex 09
France	CHU de Rouen Hopital Charles Nicolle	Rouen Cedex
France	CHU Saint Etienne Hopital Nord	Saint Etienne
France	CHU Strasbourg Hopital Hautepierre	Strasbourg Cedex
France	CHU de Toulouse Hopital Rangueil	Toulouse Cedex 09
France	Hopital de Brabois Adultes	Vandoeuvre les Nancy
Germany	Charite Campus Virchow Klinikum	Berlin
Germany	Charite Universitaetsmedizin Berlin Campus Benjamin Franklin	Berlin
Germany	DRK Kliniken Berlin Westend	Berlin
Germany	Krankenhaus Waldfriede e V	Berlin
Germany	Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH	Bochum
Germany	Staedisches Klinikum Brandenburg	Brandenburg an der Havel
Germany	Universitaetsklinikum Carl Gustav Carus TU Dresden	Dresden
Germany	Zentrum fuer HIV und Hepatogastroenterologie GmbH	Duesseldorf
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Katholische Kliniken Ruhrhalbinsel GmbH	Essen
Germany	Kliniken Essen-Mitte	Essen
Germany	Agaplesion Markus Krankenhaus	Frankfurt
Germany	Crohn Colitis Centrum Rhein Main	Frankfurt
Germany	Universitaetsklinikum FreiburgInnere Med.1, Haematologie	Freiburg
Germany	Universitaetsklinikum Halle Saale	Halle
Germany	Asklepios Klinik Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter	Heidelberg
Germany	Universitatsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Jena	Jena
Germany	Universitaetsklinikum Schleswig Holstein Campus Kiel	Kiel
Germany	EUGASTRO GmbH	Leipzig
Germany	Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen	Leipzig
Germany	University Leipzig	Leipzig
Germany	Medizinisches Zentrum Klinikum Lueneburg	Lueneburg
Germany	Universitaetsklinikum Magdeburg A oeR	Magdeburg
Germany	Klinikum Mannheim GmbH Universitaetsklinikum	Mannheim
Germany	Gastroenterologische Praxis Minden	Minden
Germany	Isar Klinik GmbH	Muenchen
Germany	Gastro Campus Research	Muenster
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Klinikum der Universitaet Muenchen	München
Germany	Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer	Niedersachsen
Germany	Universitaetsklinikum Regensburg	Regensburg
Germany	Universitaetsklinikum Ulm	Ulm
Greece	University General Hospital of Alexandroupolis	Alexandroupolis
Greece	Athens Medical Center	Athens
Greece	General Hospital of Athens Evangelismos	Athens
Greece	General Hospital of Nikaea Piraeus Ag. Panteleimon	Athens
Greece	General Hospital of Heraklion Benizeleio Pananeio	Heraklion
Greece	University General Hospital of Heraklion	Heraklion
Greece	University General Hospital of Ioannina	Ioannina
Greece	University General Hospital of Patras	Rio Patras
Greece	Anticancer Hospital of Thessaloniki THEAGENIO	Thessaloniki
Greece	General Hospital of Thessaloniki Hippokration	Thessaloniki
Hungary	DRC Gyogyszervizsgalo Kozpont Kft	Balatonfured
Hungary	Clinexpert Egeszsegugyi Szolg es Ker Kft	Budapest
Hungary	Endomedix Diagnosztikai Kozpont	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Pannonia Maganorvosi Centrum	Budapest
Hungary	Semmelweis Egyetem AOK	Budapest
Hungary	Semmelweis Egyetem AOK	Budapest
Hungary	Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Szent Pantaleon Korhaz Rendelointezet Dunaujvaros	Dunaujvaros
Hungary	Markhot Ferenc Oktato Korhaz es Rendelointezet	Eger
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Bekes Megyei Pandy Kalman Korhaz	Gyula
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz	Kaposvar
Hungary	Mohacsi Korhaz	Mohacs
Hungary	SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz	Nyiregyhaza
Hungary	Mazso-Pharma Kutatas-fejlesztesi Kft	Szeged
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Szekesfehervar
Hungary	Clinfan Szolgaltato Kft	Szekszard
Israel	HaEmek Medical Center	Afula
Israel	Soroka University Medical Center	Beer Sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Hadassah University Hospital	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Tel Aviv Sourasky Medical Center Department of Hematology	Tel Aviv
Israel	Assaf Harofeh Medical Center	Zerifin
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari
Italy	Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi	Bologna
Italy	Azienda Ospedaliera Universitaria Policlinico G Martino	Messina
Italy	Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico	Milano
Italy	Seconda Universita Degli Studi Di Napoli	Naples
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli, Campania
Italy	Hospital of Di Padova	Padova
Italy	Azienda Ospedaliera Vincenzo Cervello	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Complesso Integrato Columbus	Roma
Italy	Ospedale Sandro Pertini	Roma
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Universita Campus Bio-Medico di Roma	Roma
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Rome
Italy	Istituto Clinico Humanitas	Rozzano (MI)
Italy	Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona	Salerno
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo FG
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Hanyang Univerisy Guri Hospital	Guri-si
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	CHA Bundang Medical Center CHA University	Seongnam-si,
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, St.Vicent's Hospital	Suwon-si
Latvia	Digestive Diseases Center Gastro	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East Clinical University Hospital clinic Gailezers	Riga
Malaysia	Hospital Sultanah Bahiyah	Alor Setar	Kedah
Malaysia	Hospital Ampang	Ampang	Selangor
Malaysia	Hospital Universiti Sains Malaysia	Kelantan
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bahru	Kelantan
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Leiden Universitair Medisch Centrum	Leiden
Netherlands	Medisch Centrum Haaglanden,Antoniushoeve	Leidschendam
Netherlands	Radboudumc	Nijmegen
Netherlands	Zuyderland Medisch Centrum	Sittard-Geleen
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Netherlands	University Medical Center Utrecht	Utrecht
New Zealand	Waikato Hospital	Hamilton
Norway	Sykehuset Ostfold Fredrikstad	Fredrikstad
Norway	Akershus universitetssykehus HF	Lørenskog
Norway	Oslo Universitetssykehus HF Ulleval	Oslo
Norway	Oslo Universitetssykehus Rikshospitalet	Oslo
Norway	Stavanger Unviversitetssjukehus Helse Stavanger HF	Stavanger
Poland	SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego	Bialystok
Poland	Clinsante S.C. Osrodek Badan Klinicznych	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA	Kielce
Poland	Indywidualna Praktyka Lekarska Maciej Zymla	Knurow
Poland	Centrum Medyczne Plejady	Krakow
Poland	LUX MED Sp. z o.o.	Krakow
Poland	SPZOZ Szpital Uniwersytecki w Krakowie	Krakow
Poland	Centrum Medyczne AMED	Lodz
Poland	SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow	Lodz
Poland	GASTROMED Sp.zo.o.	Lublin
Poland	Ai Centrum Medyczne Sp. Z O.O. Sp.K.	Poznan
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Endoskopia Sp. z o.o.	Sopot
Poland	Nzoz Vivamed	Warsaw
Poland	LexMedica Osrodek Badan Klinicznych	Wroclaw
Portugal	Hospital de Braga	Braga
Portugal	Centro Hospitalar E Universitario de Coimbra EPE	Coimbra
Portugal	Hospital da Senhora da Oliveira Guimaraes	Guimaraes
Portugal	Hospital Da Luz	Lisboa
Portugal	Centro Hospitalar de Sao Joao, EPE	Porto
Portugal	Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE	Viana do Castelo
Romania	S.C MedLife S.A	Bucuresti
Romania	Tvm Med Serv Srl	Cluj Napoca
Romania	Spitalul Clinic Judetean de Urgente Sf. Spiridon	Iasi
Romania	CMI Dr. Tirnaveanu Amelita	Oradea
Romania	Centrul de Gastroenterologie Dr. Goldis	Timisoara
Russian Federation	Irkutsk State Medical Academy of Continuing Education	Irkutsk
Russian Federation	TSBIH Territorial Clinical Hospital	Krasnoyarsk
Russian Federation	Medical Center Stolitsa-Medikl	Moscow
Russian Federation	SBHI of NN region RCH of NN n.a. N.A.Semashko	Nizhny Novgorod
Russian Federation	FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS	Novosibirsk
Russian Federation	RSHI State Novosibirsk Regional Clinical Hospital	Novosibirsk
Russian Federation	SBEIHPE Novosibirsk State Medical University	Novosibirsk
Russian Federation	BHI of Omsk region Clinical Oncology Dispensary	Omsk
Russian Federation	SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF	Omsk
Russian Federation	SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral	Perm
Russian Federation	Evromedservis	Pushkin
Russian Federation	SEIHPE Rostov State Medical University of MoH of RF	Rostov-on-Don
Russian Federation	City Mariinskaya Hospital	Saint-Petersburg
Russian Federation	SPb SBIH City Hospital # 26	Saint-Petersburg
Russian Federation	NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways	Samara
Russian Federation	Private Educational Institution of Higher Education Medical university REAVIZ	Samara
Russian Federation	SHI Regional Clinical Hospital	Saratov
Russian Federation	SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno	Tosno
Russian Federation	SBHI of Yaroslavl Region Clinical Hospital 8	Yaroslavl
Serbia	Clinical Center Bezanijska Kosa	Belgrade
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Center Zemun	Belgrade
Serbia	Clinical Center Zvezdara	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Nis	Nis
Slovakia	Fakultna nemocnica s poliklinikou F. D. Roosevelta	Banska Bystrica
Slovakia	Alian s.r.o.	Bardejov
Slovakia	Gastroentero-Hepatologicke centrum THALION	Bratislava
Slovakia	Univerzitna nemocnica Bratislava Nemocnica Ruzinov	Bratislava
Slovakia	Nemocnica A.Lena Humenne n o	Humenne
Slovakia	B & B MED, s.r.o.	Kosice
Slovakia	KARDIO 1 s.r.o.	Lucenec
Slovakia	Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.	Malacky
Slovakia	Fakultna nemocnica Nitra	Nitra
Slovakia	KM Management, spol. s r.o.	Nitra
Slovakia	GASTRO I., s.r.o.	Presov
Slovakia	Nemocnica s poliklinikou sv Barbory Roznava a s	Roznava
Slovakia	Fakultna nemocnica s poliklinikou Zilina	Zilina
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda
Spain	Corporacion Sanitaria Parc Tauli	Sabadell
Spain	Hospital Universitario Infanta Sofia	San Sebastian de los Reyes
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Danderyds Sjukhus AB	Stockholm
Sweden	Sodersjukhuset	Stockholm
Sweden	Akademiska Sjukhuset	Uppsala
Switzerland	Universitaetsspital Basel	Basel
Switzerland	Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner	Bern
Switzerland	Inselspital - Universitaetsspital Bern	Bern
Switzerland	Kantonsspital St.Gallen	St. Gallen
Switzerland	Universitaetsspital Zuerich	Zuerich
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Turkiye Yuksek Ihtisas Hospital	Ankara
Turkey	Firat University Medical Faculty	Elazig
Turkey	Gaziantep University Medical Faculty Sahinbey Educational Research Hospital	Gaziantep
Turkey	Acibadem Fulya Hospital	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul
Turkey	Istanbul Medeniyet Uni Goztepe Training&Res Hosp	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty Hospital	Istanbul
Turkey	Marmara University Pendik Training and Research Hospital	Istanbul
Turkey	Yeditepe University Medical School Hospital	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Inonu Uni. Med. Fac.	Malatya
Turkey	Mersin University Medical Faculty	Mersin
Turkey	Kocaeli Derince Training and Research Hospital	Umuttepe Kocaeli
Ukraine	RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU	Chernivtsi
Ukraine	CI of PH Kharkiv CCH #2	Kharkiv
Ukraine	GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine	Kharkiv
Ukraine	Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus	Kirovohrad
Ukraine	Kyiv City Clinical Hospital #1	Kyiv
Ukraine	SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU	Kyiv
Ukraine	Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC	Kyiv
Ukraine	Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU	Lviv
Ukraine	Lviv Regional Clinical Hospital D Halytskyi Lviv NMU	Lviv
Ukraine	CI Odesa Regional Clinical Hospital	Odessa
Ukraine	Communal Institution City Policlinic #20 Cabinet of Gastroenterology	Odessa
Ukraine	M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy	Poltava
Ukraine	CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI	Sumy
Ukraine	Ternopil City Communal Emergency Medical Care Hospital	Ternopil
Ukraine	M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU	Vinnytsia
Ukraine	SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU	Vinnytsia
Ukraine	SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU	Zaporizhia
Ukraine	CI Zaporizhzhia Regional Clinical Hospital of ZRC	Zaporozhje
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Royal Devon and Exeter Hospital Wonford	Exeter
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United Kingdom	Glasgow Royal Infirmary	Glasgow, Scotland
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	Royal London Hospital	London
United Kingdom	St Marys Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung	Manchester
United Kingdom	Nottingham University Hospitals Queens Medical Centre	Nottingham
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Borders General Hospital	Roxburghshire
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury
United Kingdom	Southampton General Hospital	Southhampton
United States	Ohio Clinical Research Partners LLC	Akron	Ohio
United States	Southwest Gastroenterology Associates PC	Albuquerque	New Mexico
United States	HCP Clinical Research LLC	Anaheim	California
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Texas Clinical Research Institute LLC	Arlington	Texas
United States	Texas Digestive Disease Consultants - Dallas	Arlington	Texas
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates, LLC	Atlanta	Georgia
United States	Georgia Regents University	Augusta	Georgia
United States	University Of Colorado	Aurora	Colorado
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Gastroenterology Associates LLC	Baton Rouge	Louisiana
United States	Ehrhardt Clinical Research LLC	Belton	Missouri
United States	Boston Medical Center	Boston	Massachusetts
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	Connecticut Gastroenterology Institute	Bristol	Connecticut
United States	Commonwealth Clinical Studies PLLC	Brockton	Massachusetts
United States	Medex Research Institute	Caro	Michigan
United States	Dr. Deepak Sarwal, MD	Centerville	Ohio
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Carolina Center for Liver Disease	Charlotte	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Gaffney Health Services	Charlotte	North Carolina
United States	Charlottesville Medical Research Center	Charlottesville	Virginia
United States	University of Virginia	Charlottesville	Virginia
United States	ClinSearch LLC	Chattanooga	Tennessee
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Metropolitan Gastroenterology	Chevy Chase	Maryland
United States	Northwestern University-Feinberg School of Medicine	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research Inc.	Cincinnati	Ohio
United States	UC Health Clinical Trials Office	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Iowa Digestive Disease Center	Clive	Iowa
United States	University of Vermont	Colchester	Vermont
United States	Gastro Center of Maryland	Columbia	Maryland
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Texas Digestive Disease Consultants Dallas	Dallas	Texas
United States	AGA Clinical Research Associates LLC	Egg Harbor Township	New Jersey
United States	T. Joseph Raoof MD Inc	Encino	California
United States	Texas Digestive Disease Consultants - Southlake	Flower Mound	Texas
United States	Sing Chan Private Practice	Flushing	New York
United States	Florida Medical Research - Southeastern Integrated Medical	Gainesville	Florida
United States	Sarkis Clinical Trials - Parent	Gainesville	Florida
United States	Valley View Internal Medicine	Garden Grove	California
United States	Gastro One	Germantown	Tennessee
United States	NYU Langone Nassau Gastroenterology Associates	Great Neck	New York
United States	PhysiqueMed Clinical Trials	Greensboro	North Carolina
United States	Medical Research Center of Connecticut LLC	Hamden	Connecticut
United States	Connecticut GI PC Research Division	Hartford	Connecticut
United States	Main Line Gastroenterology	Havertown	Pennsylvania
United States	NorthShore University HealthSystem	Highland Park	Illinois
United States	Gulf Coast Research Group LLC	Houston	Texas
United States	Houston Endoscopy and Research Center	Houston	Texas
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Clinical Inquest Center Ltd	Huber Heights	Ohio
United States	ADDC Research LLC	Huntsville	Alabama
United States	Grand Teton Research Group PLLC	Idaho Falls	Idaho
United States	Indiana University	Indianapolis	Indiana
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Jefferson City Medical Group	Jefferson City	Missouri
United States	Kinston Medical Specialists PA	Kinston	North Carolina
United States	Innovative Clinical Research	Lafayette	Colorado
United States	Clinical Trials of SW Louisiana LLC	Lake Charles	Louisiana
United States	Montefiore Medical Center PRIME	Lake Success	New York
United States	OM Research	Lancaster	California
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Emeritas Research Group	Leesburg	Virginia
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Gastroenterology Associates PA	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California Medical Center	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Dean Clinic Oregon	Madison	Wisconsin
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	The Feinstein Institute for Medical Research PRIME	Manhasset	New York
United States	Arizona Digestive Health	Mesa	Arizona
United States	Advance Medical Research Center	Miami	Florida
United States	Cordova Research Institute	Miami	Florida
United States	My Community Research Center inc	Miami	Florida
United States	Sanitas Research	Miami	Florida
United States	Galiz Research LLC	Miami Springs	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	University of Minnesota	Minneapolis	Minnesota
United States	Facey Medical Foundation	Mission Hills	California
United States	Clinical Trials of America, LLC	Mount Airy	North Carolina
United States	Gastroenterology Group of Naples	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	North Shore Long Island Jewish Health System	New Hyde Park	New York
United States	Columbia University Medical Center	New York	New York
United States	Concord Medical Group PRIME	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	New York - Presbyterian/Weill Cornell Medical Center	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Henry Ford Medical Center - New Center One	Novi	Michigan
United States	Oklahoma University Health Sciences Center	Oklahoma City	Oklahoma
United States	Center For Digestive Health	Orlando	Florida
United States	GCRM	Orlando	Florida
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	BRCR Medical Center Inc.	Plantation	Florida
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Oregon Health and Science University	Portland	Oregon
United States	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York
United States	Health Science Research Center, LLC	Pratt	Kansas
United States	Hunter Holmes Mcguire Ctr	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	East Coast Institute for Research LLC	Saint Augustine	Florida
United States	Saint Louis University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Sagact Pllc	San Antonio	Texas
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Clinical Applications Laboratories Inc	San Diego	California
United States	Medical Associates Research Group Inc.	San Diego	California
United States	University of California at San Francisco	San Francisco	California
United States	Colon & Digestive Health Specialists	Scottsdale	Arizona
United States	Harborview Medical Center	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	University of Washington School of Medicine	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Louisiana Research Center LLC	Shreveport	Louisiana
United States	Mercy Research	Springfield	Missouri
United States	Springfield Health Care Center	Springfield	Ohio
United States	Penn State University Milton S Hershey Medical Center	State College	Pennsylvania
United States	Arizona Digestive Health	Sun City	Arizona
United States	Atlanta Gastroenterology Specialists PC	Suwanee	Georgia
United States	Scott & White Medical Center	Temple	Texas
United States	Digestive Health Specialist of Tyler	Tyler	Texas
United States	The Vancouver Clinic	Vancouver	Washington
United States	Ventura Clinical Trials	Ventura	California
United States	Mercy Clinic East Communities d/b/a Mercy Health Research	Washington	Missouri
United States	Cleveland Clinic Florida Weston	Weston	Florida
United States	Heartland Research Associates LLC	Wichita	Kansas
United States	Via Christi Research a division of Via Christi Hospitals Wichita Inc	Wichita	Kansas
United States	Trial Management Associates LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem LLC	Winston-Salem	North Carolina
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina
United States	Shafran Gastroenterology Center	Winter Park	Florida
United States	UMass Medical Center	Worcester	Massachusetts
United States	Gastroenterology Associates of Western Michigan PLC	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Malaysia,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants Who Achieved a Clinical Remission at Week 12	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 12
Secondary	Percentage of Participants Who Achieved Clinical Remission at Week 52	Clinical remission is defined as a CDAI score < 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 52
Secondary	Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52	An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: Ulcers scored as: 0: no; aphthous (0.1-0.5 cm); large (0.5-2 cm); very large (>2 cm); Surface involved disease 0: 0%; <50%; 50-75%; >75%; Surface involved by ulcerations: 0: 0%; <10%; 10-30%; >30% - Narrowings: 0: No; Single, can be passed; Multiple, can be passed; Cannot be passed Grand Total = SES-CD score	Week 52
Secondary	The Percentage of Participants Who Achieved a Clinical Response at Week 12	A clinical response is defined as a CDAI score decrease from baseline = 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 12
Secondary	The Percentage of Participants Who Achieved a Clinical Response at Week 4	A clinical response is defined as a decrease from baseline in CDAI = 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 4
Secondary	The Percentage of Participants Who Achieved a Clinical Remission at Week 4	A clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 4
Secondary	The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52	The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score <150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Week 52
Secondary	Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52	For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.	Weeks 12 and 52
Secondary	Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12	An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: Ulcers scored as: 0: no; aphthous (0.1-0.5 cm); large (0.5-2 cm); very large (>2 cm); Surface involved disease 0: 0%; <50%; 50-75%; >75%; Surface involved by ulcerations: 0: 0%; <10%; 10-30%; >30% - Narrowings: 0: No; Single, can be passed; Multiple, can be passed; Cannot be passed Grand Total = SES-CD score	Week 0, Week 12
Secondary	Percentage of Participants With Endoscopic Remission Centrally Read at Week 52	Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of =2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include: Ulcers scored as: 0: no; aphthous (0.1-0.5 cm); large (0.5-2 cm); very large (>2 cm); Surface involved disease 0: 0%; <50%; 50-75%; >75%; Surface involved by ulcerations: 0: 0%; <10%; 10-30%; >30% - Narrowings: 0: No; Single, can be passed; Multiple, can be passed; Cannot be passed Grand Total = SES-CD score	Week 52
Secondary	The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52	A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.	From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks
Secondary	The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events	A TEAE was defined as any AE occurring or worsening on or after the first dose of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.	From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks