Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307) (CARMEN CD 307)
March 3, 2022 updated by: Shire
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 Crohn's Disease (CARMEN CD 307)
The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1093AAS
- Fundacion Favaloro
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Córdoba, Argentina
- Hospital Privado Centro Medico de Cordoba
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New South Wales
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Concord, New South Wales, Australia, 2139
- Concord Repatriation General Hospital
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Mater Hospital Brisbane
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Victoria
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Fitzroy, Victoria, Australia, 3065
- St Vincents Hospital Melbourne - PPDS
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Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
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Salzburg, Austria, 5020
- Salzburger Landeskliniken
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Wien, Austria, 1090
- Medizinische Universitat Wien (Medical University of Vienna)
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Steiermark
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Graz, Steiermark, Austria, 8036
- LKH-Universitätsklinikum Klinikum Graz
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Wien
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Vienna, Wien, Austria, A-1090
- Klinikum Wels-Grieskirchen GmbH
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Mouscron, Belgium, 7700
- CHU Mouscron
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Antwerpen
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Bonheiden, Antwerpen, Belgium, 2820
- Academisch Medisch Centrum Amsterdam
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Oost-Vlaanderen
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Gent, Oost-Vlaanderen, Belgium, 9000
- UZ Gent
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgium, 8500
- AZ Groeninge
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Banja Luka, Bosnia and Herzegovina, 78000
- Clinical Center Banja Luka
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Plovdiv, Bulgaria, 4004
- Multiprofile Hospital for Active Treatment Eurohospital
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Sofia, Bulgaria, 1680
- Medical Center Convex EOOD
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Sofia, Bulgaria, 1202
- Second Multiprofile Hospital for Active Treatment Sofia
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Sofia, Bulgaria, 1431
- Diagnostic and Consulting Center Aleksandrovska EOOD
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Sofia, Bulgaria, 1431
- University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
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Sofia, Bulgaria, 1527
- University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
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Sofia, Bulgaria, 1632
- Medical Center Excelsior OOD - PPDS
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Varna, Bulgaria, 9000
- Diagnostic Consultative Centre Mladost - M OOD
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Sofia-Grad
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Sofia, Sofia-Grad, Bulgaria, 1784
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
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Cali, Colombia
- IPS Centro Médico Julián Coronel S.A.S. - PPDS
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Valle Del Cauca
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Cali, Valle Del Cauca, Colombia, 760026
- Fundacion Valle del Lili
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Bjelovar, Croatia, 43000
- Opća bolnica Bjelovar
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Osijek, Croatia, 31000
- Clinical Hospital Centre Osijek
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Virovitica, Croatia, 33000
- General Hospital Virovitica
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Grad Zagreb
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Zagreb, Grad Zagreb, Croatia, 10000
- University Hospital Center Zagreb
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Parnu, Estonia, 80010
- OÜ LV Venter
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Tallinn, Estonia, 10617
- West Tallinn Central Hospital
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Berlin, Germany, 13353
- Charité - Universitätsmedizin Berlin
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Berlin-Zehlendorf, Germany, 14163
- Gastroenterologische Facharztpraxis am Mexikoplatz
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Biberach an der Riss, Germany, 88400
- Sana Klinikum Biberach
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Frankfurt, Germany, 60596
- Universitätsklinikum Frankfurt
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Bayern
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Munich, Bayern, Germany, 81675
- Klinikum rechts der Isa der Technischen Universitaet Muenchen
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Nordrhein-Westfalen
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Aachen, Nordrhein-Westfalen, Germany, 52074
- Universitatsklinikum der RWTH Aachen
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Köln, Nordrhein-Westfalen, Germany, 50937
- Uniklinik Köln
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Münster, Nordrhein-Westfalen, Germany, 48159
- Gastro Campus Research GbR
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24105
- Universitatsklinikum Schleswig-Holstein
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Thüringen
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Jena, Thüringen, Germany, 07747
- Universitatsklinikum Jena
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Heraklion, Greece, 71110
- University General Hospital of Heraklion
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Paliao Faliro, Greece, 17562
- Iatriko Palaiou Falirou
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Patras, Greece, 26504
- University General Hospital of Patras
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Thessaloniki, Greece, 54645
- Euromedica - PPDS
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Attiki
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Athens, Attiki, Greece, 11527
- Ippokrateio General Hospital of Athens
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Bekescsaba, Hungary, 5600
- Békés Megyei Központi Kórház
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Budapest, Hungary, 1062
- Magyar Honvedseg Egeszsegugyi Kozpont
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Budapest, Hungary, 1135
- Pannónia Magánorvosi Centrum Kft
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Budapest, Hungary, 1139
- Endomedix Kft.
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Debrecen, Hungary, 4032
- Debreceni Egyetem Klinikai Kozpont
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Mohacs, Hungary, 7700
- Mohacsi Korhaz
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Szekszard, Hungary, 7100
- Tolna Megyei Balassa Janos Korhaz
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Székesfehérvár, Hungary, 8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Dublin, Ireland, 4
- St Vincent's University Hospital
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Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
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Jerusalem, Israel, 91120
- Hadassah Medical Center - PPDS
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Nahariya, Israel, 22100
- Galilee Medical Center
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Tiberias, Israel, 15208
- Baruch Padeh Poriya Medical Center
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Novara, Italy, 28100
- A.O.U. Maggiore della Carita
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Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo di Pavia
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Roma, Italy, 00161
- La Sapienza-Università di Roma-Policlinico Umberto I
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Rozzano (MI), Italy, 20089
- Istituto Clinico Humanitas
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San Giovanni Rotondo, Italy, 71013
- Ospedale Casa Sollievo Della Sofferenza IRCCS
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Torino, Italy, 10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
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Calabria
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Catanzaro, Calabria, Italy, 88100
- Azienda Ospedaliera Mater Domini Di Catanzaro
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Emilia-Romagna
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Modena, Emilia-Romagna, Italy, 41100
- Azienda Ospedaliero Universitaria Di Modena Policlinico
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Lazio
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Roma, Lazio, Italy, 00168
- Fondazione Policlinico Universitario A Gemelli
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Toscana
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Firenze, Toscana, Italy, 50134
- Azienda Ospedaliera Universitaria Careggi
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Veneto
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Negrar, Veneto, Italy, 37024
- IRCCS Ospedale Sacro Cuore Don Calabria
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Asahikawa, Japan, 070-0061
- Kunimoto Hospital
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Kurume-shi, Japan, 839-0809
- Hidaka Coloproctology Clinic
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Nagakute, Japan, 480-1195
- Aichi Medical University Hospital
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Nishinomiya, Japan, 663-8014
- Nishinomiya Municipal Central Hospital
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Onomichi, Japan
- Onomichi General Hospital
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Osaka, Japan, 530-0003
- Chiinkai Dojima General & Gastroenterology Clinic
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Osaka, Japan, 533-0024
- Yodogawa Christian Hospital
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Osaka-shi, Japan, 530-0011
- Kinshukai Infusion Clinic
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Otsu-Shi, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Sakura, Japan, 285-8741
- Toho University Sakura Medical Center
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Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sapporo-shi, Japan, 065-0033
- Sapporo Tokushukai Hospital
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Shimotsuga-gun, Japan, 321-0293
- Dokkyo Medical University Hospital
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Tokyo, Japan, 103-0028
- Nihonbashi Egawa Clinic
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Yokohama, Japan, 220-0045
- Colo-proctology Center Matsushima Clinic
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Hokkaidô
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Sapporo, Hokkaidô, Japan, 060-8543
- Sapporo Medical University Hospital
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Hyôgo
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Kobe-shi, Hyôgo, Japan, 650-0015
- Medical Corporation Aoyama Clinic
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Nishinomiya-shi, Hyôgo, Japan, 663-8501
- Hyogo College of Medicine
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Tokyo
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Minato-ku, Tokyo, Japan, 105-8471
- Jikei University Hospital
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Ome, Tokyo, Japan, 198-0042
- Ome Municipal General Hospital
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Ôita
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Oita-city, Ôita, Japan, 870-0823
- Ishida Clinic of IBD and Gastroenterology
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Busan, Korea, Republic of, 49241
- Pusan National University Hospital
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Busan, Korea, Republic of, 48108
- Inje University Haeundae Paik Hospital
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Daegu, Korea, Republic of, 41944
- Kyungpook National University Hospital
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Daegu, Korea, Republic of, 702-210
- Kyungpook National University Chilgok Hospital
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Incheon, Korea, Republic of, 21565
- Gachon University Gil Medical Center
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03181
- Kangbuk Samsung Hospital
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Seoul, Korea, Republic of, 04551
- Inje University Seoul Paik Hospital
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Gang'weondo
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Wonju, Gang'weondo, Korea, Republic of, 26426
- Yonsei University Wonju Severance Christian Hospital
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Gyeonggido
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Seongnam, Gyeonggido, Korea, Republic of, 13496
- CHA Bundang Medical Center, CHA University
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Suwon, Gyeonggido, Korea, Republic of, 16247
- The Catholic University of Korea, St. Vincent's Hospital
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Beirut, Lebanon
- Al Zahraa university hospital
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Saida, Lebanon
- Hammoud Hospital University Medical Center
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Vilnius, Lithuania, LT- 08661
- Vilnius University Hospital Santaros Klinikos
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Vilnius, Lithuania, LT-10207
- Vilnius city clinical hospital
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Distrito Federal, Mexico, 07020
- Centro de Investigación Clinica Acelerada, S.C.
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Durango, Mexico, 34000
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
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Jalisco
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Zapopan, Jalisco, Mexico, 45030
- Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
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Morelos
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Cuernavaca, Morelos, Mexico, 62170
- Clinica de Higado y Gastroenterologia Integral, S.C.
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Cuernavaca, Morelos, Mexico, 62290
- JM Research S.C
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Nuevo León
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Monterrey, Nuevo León, Mexico, 64000
- Accelerium, S. de R.L. de C.V.
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Yucatán
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Merida, Yucatán, Mexico, 97000
- Unidad de Atención Médica e Investigación en Salud
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Noord-Brabant
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Tilburg, Noord-Brabant, Netherlands, 5022 GC
- ETZ-Elisabeth
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Noord-Holland
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Den Helder, Noord-Holland, Netherlands, 1782 GZ
- NWZ, location Alkmaar
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Hamilton, New Zealand, 3240
- Waikato Hospital
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South Island
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Dunedin, South Island, New Zealand, 9016
- Dunedin Hospital
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Wellington
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Newtown, Wellington, New Zealand, 6021
- Wellington Hospital
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Bydgoszcz, Poland, 85-168
- Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
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Czestochowa, Poland, 42-200
- Centrum Medyczne Czestochowa - PRATIA - PPDS
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Gdynia, Poland, 81-338
- Centrum Medyczne Gdynia - PRATIA - PPDS
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Katowice, Poland, 40-660
- NZOZ All Medicus
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Lodz, Poland, 91-034
- Med Gastr Sp.z.o.o Sp.k
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Lodz, Poland, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Nowa Sól, Poland, 67-100
- Twoja Przychodnia - Centrum Medyczne Nowa Sol
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Poznan, Poland, 60-848
- Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
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Rzeszow, Poland, 35-068
- Centrum Medyczne Warszawa - PRATIA - PPDS
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Rzeszow, Poland, 35-302
- Korczowski Bartosz, Gabinet Lekarski
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Szczecin, Poland, 71-685
- Sonomed Sp. z o.o.
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Warszawa, Poland, 00-635
- Centrum Zdrowia M D M
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Warszawa, Poland, 02-507
- Centralny Szpital Kliniczny MSW
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Warszawa, Poland, 02-797
- BioVirtus Centrum Medyczne
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Zamosc, Poland, 22-400
- Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
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Dolnoslaskie
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Wroclaw, Dolnoslaskie, Poland, 50-449
- Melita Medical
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Wroclaw, Dolnoslaskie, Poland, 53-114
- LexMedica
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Kujawsko-pomorskie
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Bydgoszcz, Kujawsko-pomorskie, Poland, 85-079
- Vitamed Galaj i Cichomski sp.j.
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Torun, Kujawsko-pomorskie, Poland, 87-100
- Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
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Wloclawek, Kujawsko-pomorskie, Poland, 87-800
- Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
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Lódzkie
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Lódz, Lódzkie, Poland, 90-302
- Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
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Lódz, Lódzkie, Poland, 90-647
- Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
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Mazowieckie
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Warszawa, Mazowieckie, Poland, 02-781
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
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Warszawa, Mazowieckie, Poland, 03-580
- Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
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Warszawa, Mazowieckie, Poland, 04-749
- Międzyleski Szpital Specjalistyczny w Warszawie
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Podlaskie
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Bialystok, Podlaskie, Poland, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Pomorskie
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Sopot, Pomorskie, Poland, 81-756
- Endoskopia Sp. z o.o.
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Swietokrzyskie
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Konskie, Swietokrzyskie, Poland, 26-200
- Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
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Zachodniopomorskie
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Szczecin, Zachodniopomorskie, Poland, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Guimarães, Portugal, 4835-044
- Hospital Senhora da Oliveira - Guimaraes, E.P.E
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Lisboa, Portugal, 1500-650
- Hospital da Luz
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Portimão, Portugal, 8500-338
- Centro Hospitalar do Algarve - Hospital de Portimao
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Bucharest, Romania, 022328
- Fundeni Clinical Institute
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Bucharest, Romania, 010825
- Dr.Carol Davila Emergency University Central Military Hospital
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Bucharest, Romania, 020125
- Colentina Clinical Hospital
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Bucharest, Romania, 021105
- Prof. Dr. Matei Bals Institute of Infectious Diseases
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Bucharest, Romania, 050098
- Emergency University Hospital
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Bucuresti, Romania, 031864
- Centrul Medical Hifu Terramed Conformal S.R.L.
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Constanta, Romania, RO-900591
- Affidea Romania SRL
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Iasi, Romania, 700506
- GastroMedica SRL
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Oradea, Romania, 410066
- Dr. Tirnaveanu Amelita Private Practice
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Timisoara, Romania, 300002
- Dr. Goldis Gastroenterology Center SRL
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Bucuresti
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Bucharest, Bucuresti, Romania, 011025
- Sana Monitoring SRL
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Cluj
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Cluj-Napoca, Cluj, Romania, 400006
- Cluj-Napoca Emergency Clinical County Hospital
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Rostov-on-Don, Russian Federation, 344091
- Rostov State Medical University
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Saint Petersburg, Russian Federation
- Russian Medical Military Academy n.a. S.M. Kirov
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Samara, Russian Federation, 443011
- Medical University Reaviz
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Samara, Russian Federation, 443029
- Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
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Saratov, Russian Federation, 410012
- SHI Regional Clinical Hospital
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St. Petersburg, Russian Federation, 195067
- St. Elizabeth Municipal Clinical Hospital
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Belgrade, Serbia, 11080
- Clinical Hospital Center Bezanijska Kosa
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Nis, Serbia, 18000
- University Clinical Center Nis
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Vrsac, Serbia, 26300
- General Hospital Vršac
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Zemun, Serbia
- Clinical Hospital Center Zemun
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Šumadijski Okrug
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Kragujevac, Šumadijski Okrug, Serbia, 34000
- University Clinical Center Kragujevac
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Nitra, Slovakia, 949 01
- KM Management, spol. s r.o.
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Presov, Slovakia, 080 01
- Gastro LM, s.r.o.
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Gauteng
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Johannesburg, Gauteng, South Africa, 1619
- CLINRESCO, ARWYP Medical Suites
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Pretoria, Gauteng, South Africa, 0084
- Dr. J Breedt
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Western Cape
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Claremont, Western Cape, South Africa, 7708
- Dr JP Wright
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Barcelona, Spain, 08022
- Centro Medico Teknon - Grupo Quironsalud
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Huelva, Spain, 21005
- Hospital Universitario Juan Ramón Jiménez
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Madrid, Spain, 28040
- Hospital Universitario Fundación Jiménez Díaz
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Madrid, Spain, 28046
- Hospital Universitario La Paz - PPDS
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Sevilla, Spain, 41013
- Hospital Universitario Virgen del Rocio - PPDS
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Córdoba
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Cordoba, Córdoba, Spain, 14004
- C.H. Regional Reina Sofia - PPDS
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Madrid
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Fuenlabrada, Madrid, Spain, 28942
- Hospital Universitario de Fuenlabrada
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Madrid, Communidad Delaware
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Madrid, Madrid, Communidad Delaware, Spain, 28007
- Hospital General Universitario Gregorio Marañón
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Pontevedra
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Vigo, Pontevedra, Spain, 36312
- CHUVI - H.U. Alvaro Cunqueiro
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Mersin, Turkey, 33169
- Mersin University Medical Faculty
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Dnipro, Ukraine, 49038
- LLC Medical Center Family Medicine Clinic
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Kharkiv, Ukraine, 61058
- Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
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Kherson, Ukraine, 73000
- Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
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Kyiv, Ukraine, 01023
- Medical Center of LLC Medical Clinic Blagomed
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Kyiv, Ukraine, 02091
- Medical Center OK!Clinic+LLC International Institute of Clinical Research
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Kyiv, Ukraine, 02132
- Medical Center of LLC Medical Center Dopomoga-Plus
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Kyiv, Ukraine, 04073
- Municipal Institution of KRC Kyiv Regional Hospital #2
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Lviv, Ukraine, 79059
- Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
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Vinnytsia, Ukraine, 21029
- Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
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Zaporizhzhia, Ukraine, 69035
- MNPE City Hospital No. 6 of Zaporizhzhia City Council
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Chernivets'ka Oblast
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Chernivtsi, Chernivets'ka Oblast, Ukraine, 58001
- Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
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Kharkivs'ka Oblast
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Kharkiv, Kharkivs'ka Oblast, Ukraine, 61037
- Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
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Kyïv
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Kyiv, Kyïv, Ukraine, 04107
- Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
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Aberdeen, United Kingdom, AB25 2ZN
- Aberdeen Royal Infirmary - PPDS
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Newport, United Kingdom, NP20 2UB
- Royal Gwent Hospital - PPDS
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Wolverhampton, United Kingdom, WV10 0QP
- New Cross Hospital
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Northumberland
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North Shields, Northumberland, United Kingdom, NE29 8NH
- North Tyneside General Hospital
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Arizona
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Mesa, Arizona, United States, 85206
- Arizona Digestive Health Mesa - East
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Phoenix, Arizona, United States, 85018
- Elite Clinical Studies - Phoenix - Clinedge - PPDS
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Tucson, Arizona, United States, 85724
- CATS Research Center - University of Arizona
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Arkansas
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Little Rock, Arkansas, United States, 72209
- Atria Clinical Research - Clinedge - PPDS
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California
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Anaheim, California, United States, 92805
- Advanced Research Center
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Corona, California, United States, 92879
- Kindred Medical Institute for Clinical Trials, LLC
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Lancaster, California, United States, 93534
- OM Research LLC - Lancaster - ClinEdge - PPDS
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Poway, California, United States, 92064
- Alliance Clinical Research-(Vestavia Hills)
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Rialto, California, United States, 92377
- Inland Empire Liver Foundation
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San Pablo, California, United States, 94806
- Care Access Research, San Pablo
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Colorado
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Colorado Springs, Colorado, United States, 80903
- Peak Gastroenterology Associates
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Colorado Springs, Colorado, United States, 80907
- Asthma and Allergy Associates PC - CRN - PPDS
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Florida
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Cape Coral, Florida, United States, 33991
- Renaissance Research Medical Group, INC
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Clearwater, Florida, United States, 33756
- Gastro Florida
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Coral Gables, Florida, United States, 33134
- Advanced Clinical Research Network
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Coral Springs, Florida, United States, 33071
- Alliance Medical Research LLC
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Kissimmee, Florida, United States, 34741
- SIH Research
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Miami, Florida, United States, 33135
- Hi Tech and Global Research, LLC
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Miami, Florida, United States, 33157
- Sanchez Clinical Research, Inc
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Miami Lakes, Florida, United States, 33065
- Crystal Biomedical Research
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Naples, Florida, United States, 34102
- Gastroenterology Group of Naples
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Naples, Florida, United States, 34110
- Pharma Research International Inc
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Orlando, Florida, United States, 32810
- Omega Research Consultants LLC - Clinedge - PPDS
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Pinellas Park, Florida, United States, 33781
- Accel Research Sites - St. Petersburg - ERN - PPDS
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Saint Augustine, Florida, United States, 32086
- East Coast Institute for Research, LLC
-
Tamarac, Florida, United States, 33321
- DBC Research
-
Tampa, Florida, United States, 33604
- Bayside Clinical Research - New Port Richey
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- Atlanta Gastroenterology Specialists, PC
-
Atlanta, Georgia, United States, 30349
- Infinite Clinical Trials
-
Decatur, Georgia, United States, 30033
- Atlanta Center For Gastroenterology PC
-
-
Illinois
-
Chicago, Illinois, United States, 60644
- Loretto Hospital
-
Gurnee, Illinois, United States, 60031
- IL Gastroenterology Group
-
-
Indiana
-
Michigan City, Indiana, United States, 46360
- LaPorte County Institute for Clinical Research
-
-
Kansas
-
Topeka, Kansas, United States, 66606
- Cotton O'Neil Clinical Research Center
-
-
Kentucky
-
Hazard, Kentucky, United States, 41701
- Gastroenterology Associates Of Hazard
-
-
Louisiana
-
Houma, Louisiana, United States, 70360
- CroNOLA, LLC.
-
Lake Charles, Louisiana, United States, 70601
- Clinical Trials of SWLA, LLC
-
New Orleans, Louisiana, United States, 70115
- DelRicht Clinical Research, LLC - ClinEdge - PPDS
-
Shreveport, Louisiana, United States, 71103
- Louisiana Research Center LLC
-
-
Massachusetts
-
Brockton, Massachusetts, United States, 02302
- Commonwealth Clinical Studies LLC
-
Winchester, Massachusetts, United States, 22601
- Winchester Gastroenterology Associates
-
Worcester, Massachusetts, United States, 01655
- UMass Memorial Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
Chesterfield, Michigan, United States, 48047
- Clinical Research Institute of Michigan
-
Hamtramck, Michigan, United States, 48212
- National Clinical, LLC
-
Wyoming, Michigan, United States, 49519
- Gastroenterology Associates of Western Michigan, PLC
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- Mayo Clinic Health System - PPDS
-
Saint Paul, Minnesota, United States, 55114
- Minnesota Gastroenterology PA
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
-
Nevada
-
Las Vegas, Nevada, United States, 89123
- Advanced Biomedical Research of America
-
North Las Vegas, Nevada, United States, 89086
- Encompass Care
-
-
New York
-
Brooklyn, New York, United States, 11215
- New York Total Medical Care PC
-
Great Neck, New York, United States, 11021
- NYU Langone Long Island Clinical Research Associates
-
Orchard Park, New York, United States, 14127
- Southtowns Gastroenterology, PLLC
-
-
North Carolina
-
Statesville, North Carolina, United States, 28625
- Piedmont Healthcare
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Consultants For Clinical Research Inc
-
Cincinnati, Ohio, United States, 45249
- Consultants For Clinical Research Inc
-
Fairfield, Ohio, United States, 45014
- Consultants For Clinical Research Inc
-
-
Pennsylvania
-
State College, Pennsylvania, United States, 16803
- Penn State Hershey Medical Group
-
Wyomissing, Pennsylvania, United States, 19610
- Digestive Disease Associates
-
-
Tennessee
-
Germantown, Tennessee, United States, 38138
- Gastro One
-
Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
-
Union City, Tennessee, United States, 38261
- Advanced Gastroenterology-Union City
-
-
Texas
-
Cypress, Texas, United States, 77429
- Northside Gastroenterology
-
Garland, Texas, United States, 75044
- Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
-
Houston, Texas, United States, 77074
- Southwest Clinical Trials
-
Houston, Texas, United States, 77039
- Precision Research Institute, LLC
-
Houston, Texas, United States, 77043
- Biopharma Informatic Inc.
-
Houston, Texas, United States, 77084
- BI Research Center
-
San Antonio, Texas, United States, 78229
- Southern Star Research Institute LLC
-
Webster, Texas, United States, 77598
- Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
-
-
Utah
-
Bountiful, Utah, United States, 84010
- HP Clinical Research
-
-
Virginia
-
Galax, Virginia, United States, 24333
- Mid Atlantic Health Specialists
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants and/or their parent or legally authorized representative (LAR) 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 LAR) informed consent and/or assent, as applicable, to participate in the study.
Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:
- Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or
- Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline:
- Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO sub scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the Bristol Stool Form Scale (BSFS) over the 7 most recent days*.
- A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.
- A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.
A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO sub score of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*.
*Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.
- Participants receiving any treatments for CD 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 deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
- Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
- Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).
- Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male 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 developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).
- 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 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 studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.
Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrollment in Study SHP647-307.
- Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN).
- Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.
- Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).
- Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).
- White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).
- Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)
Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.
- Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
- Participants 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 other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ontamalimab 25 mg
Participants will receive 25 mg of ontamalimab subcutaneous (SC) injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
|
SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.
Other Names:
|
|
Experimental: Ontamalimab 75 mg
Participants will receive 75 mg of ontamalimab SC injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
|
SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.
Other Names:
|
|
Placebo Comparator: Placebo
Participants will receive placebo matched with ontamalimab SC injection using prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).
|
SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Clinical Remission at Week 52
Time Frame: At Week 52
|
Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point numerical rating scale [NRS] ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the Bristol Stool Form Scale (BSFS) over the 7 most recent days.
BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid).
Participants with missing data at Week 52 or discontinuation before Week 52 were considered failures.
Number of participants with clinical remission at Week 52 were reported.
|
At Week 52
|
|
Number of Participants With Enhanced Endoscopic Response at Week 52
Time Frame: At Week 52
|
Enhanced endoscopic response was defined as a decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) of at least 50 percent (%) from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823] baseline.
The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing.
Each graded from 0-3.
Scale ranges from 0-56 with a higher score indicating greater severity of disease.
Participants with missing data at Week 52 or who discontinued before Week 52 were considered non responders.
Number of participants with enhanced endoscopic response at Week 52 were reported.
|
At Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52
Time Frame: At Week 52
|
Clinical remission was defined as a CDAI score of <150.
CDAI assessed CD based on clinical signs/symptoms such as number of liquid stools, intensity of abdominal pain, general well-being (subjective), and presence of complications, use of antidiarrheal, presence of abdominal mass, physical examination and hematocrit (objective).
CDAI score is equal to sum of weighted scores for subjective and objective items which range from 0-149 points: asymptomatic remission, 150-220 points: mild to moderate active CD, 221-450 points: moderate to severe active CD, >451 points: severely active to fulminant disease.
Higher score indicating more severity.
Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures.
Number of participants with clinical remission as measured by CDAI at Week 52 were reported.
|
At Week 52
|
|
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
Time Frame: At Week 52
|
Glucocorticoid-free clinical remission defined as clinical remission by 2-item PRO not requiring any treatment with glucocorticoids for at least 12 weeks prior to Week 52 visit.
Clinical remission defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency<=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days.
BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, mushy stool), 7 (watery, no solid pieces, entirely liquid).
Participants with missing data at Week 52 or who discontinued before Week 52 were non-responders.
Number of participants with glucocorticoid-free clinical remission response at Week 52 were reported.
|
At Week 52
|
|
Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52
Time Frame: At Week 52
|
Clinical remission was defined by CD daily e-diary 2-item PRO subscores of average daily abdominal pain <=1 (based on the 4 point scale, with scores ranging from 0 [none] to 3 [severe]) over the 7 most recent days and average daily stool frequency <=3 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days.
BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid).
Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures.
Number of participants with clinical remission based on Crohn's Disease (CD) e-diary Sub-scores for abdominal pain was was reported.
|
At Week 52
|
|
Number of Participants With Sustained Clinical Remission at Week 52
Time Frame: At Week 52
|
Sustained clinical remission was defined as clinical remission by 2-item PRO at both Week 52 visit and the maintenance baseline in this Study.
Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain less than or equal to (<=) 3 (based on 11 point NRS ranging from 0 [no pain] to 10 [worst imaginable pain]); and average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as per the BSFS over the 7 most recent days.
BSFS ranges from 1 (separate hard lumps, hard to pass), 2 (sausage-shaped, but lumpy), 3 (like a sausage but with cracks on the surface), 4 (like a sausage or snake, smooth and soft), 5 (soft blobs with clear-cut edges), 6 (fluffy pieces with ragged edges, a mushy stool), 7 (watery, no solid pieces, entirely liquid).
Number of participants with sustained clinical remission at Week 52 were reported.
|
At Week 52
|
|
Number of Participants With Sustained Enhanced Endoscopic Response at Week 52
Time Frame: At Week 52
|
Sustained enhanced endoscopic response was defined as enhanced endoscopic response at both Week 52 visit and the maintenance baseline in this study.
Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50 % from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline.
The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing.
Each graded from 0-3.
Scale ranges from 0-56 with a higher score indicating greater severity of disease.
Number of participants with sustained enhanced endoscopic response at Week 52 were reported.
|
At Week 52
|
|
Number of Participants With Clinical Remission Based on 2-item PRO With Enhanced Endoscopic Response at Week 52
Time Frame: At Week 52
|
Clinical remission was defined by 2-item PRO sub-scores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days and average daily stool frequency <= 2 of Type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days.
Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures.
Enhanced endoscopic response was defined as a decrease in SES-CD of at least 50% from induction study (either SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) baseline.
Participants with missing data at Week 52 or who discontinued before Week 52 were considered non-responders.
|
At Week 52
|
|
Number of Participants With Complete Endoscopic Healing at Week 52
Time Frame: At Week 52
|
Complete endoscopic healing was defined as SES-CD scale score from 0-2.
The SES-CD considers ileum, right colon, transverse colon, left colon, rectum in terms of: size of ulcers, ulcerated surface, affected surface and presence of narrowing.
Each graded from 0-3.
Scale ranges from 0-56 with a higher score indicating greater severity of disease.
Participants with missing data at Week 52 or who discontinued before Week 52 were considered failures.
Number of participants with complete endoscopic healing at Week 52 were reported.
|
At Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2019
Primary Completion (Actual)
June 21, 2021
Study Completion (Actual)
September 13, 2021
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
August 9, 2018
First Posted (Actual)
August 13, 2018
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 3, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHP647-307
- 2017-000617-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).
These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/.
For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.