Phase
Condition
Colic
Ulcers
Inflammatory Bowel Disease
Treatment
UTTR1147A
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Inclusion Criteria for Study Entry:
- Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entrycriteria Inclusion Criteria for Study Entry and Study Re-Entry:
- Ability to comply with requirements of the study, in the investigator's judgment
- For women and men: use of highly effective contraception as defined by the protocol.
Exclusion
Exclusion Criteria: Exclusion Criteria for Study Entry:
- Withdrawal of consent from parent study
- Discontinuation of study drug as required by the parent study protocol
- Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 orfrom Study GA39925 prior to Week 8
- Noncompliance in the parent study, specifically defined as missing scheduled visits ornon-adherence with background medications and concomitant medications Exclusion Criteria for Study Entry and Study Re-Entry:
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or within 18 weeks after the final dose ofstudy drug from GA39925, whichever is longer
- Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary,renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms ofinfection judged by the investigator to be clinically significant since enrolling inthe parent study
- Use of prohibited therapies as defined in the parent study
- Abnormal laboratory values, as defined in the protocol, recorded at the last visit inthe parent study Exclusion Criterion for Study Re-Entry:
- Use of prohibited concomitant therapy since enrolling in the extension study
Study Design
Connect with a study center
MHAT Saint Karidad EAD
Plovdiv, 4000
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment Hadji Dimitar OOD
Sliven, 8800
BulgariaSite Not Available
Synexus - Medical Center Synexus Sofia EOOD
Sofia, 1784
BulgariaSite Not Available
Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
Stara Zagora, 6000
BulgariaSite Not Available
Medical Center Medica Plus OOD
Veliko Tarnovo, 5000
BulgariaSite Not Available
Peking University Third Hospital
Beijing, 100083
ChinaSite Not Available
Beijing Chaoyang Hospital Capital Medical University
Beijing City, 100020
ChinaSite Not Available
Third Xiangya Hospital Centrel South University
Changsha, 410013
ChinaSite Not Available
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu City, 610072
ChinaSite Not Available
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, 510655
ChinaSite Not Available
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou City, 510080
ChinaSite Not Available
Affiliated Hospital of Guilin Medical University
Guilin City, 541001
ChinaSite Not Available
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016
ChinaSite Not Available
Nanjing First Hospital
Nanjing City, 210029
ChinaSite Not Available
Shanghai General Hospital
Shanghai, 201620
ChinaSite Not Available
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai City, 200127
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin (天津), 300052
ChinaSite Not Available
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, 430030
ChinaSite Not Available
Zhongshan Hospital Xiamen University
Xiamen, 361004
ChinaSite Not Available
CHU Amiens Picardie- Hôpital Nord
Amiens, 80054
FranceSite Not Available
Hopital Cote De Nacre; Hematologie Clinique
Caen, 14033
FranceSite Not Available
CHU de GRENOBLE; Clinique Medicale De Pediatrie
Grenoble, 38043
FranceSite Not Available
CHRU Lille
Lille, 59037
FranceSite Not Available
Hôpital L'archet 2
Nice, 06202
FranceSite Not Available
CHU du Reims - Hopital Robert Debré
Reims, 51092
FranceSite Not Available
LLC ARENSIA Exploratory Medicine
Tbilisi, 0112
GeorgiaSite Not Available
Gastroenterologische Spezialpraxis-Berlin-Karlshorst
Berlin, 10318
GermanySite Not Available
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
GermanySite Not Available
AES - DRS - Synexus Frankfurt Research Centre
Frankfurt, 60313
GermanySite Not Available
Asklepios Westklinikum Hamburg Ggmbh; Gastroenterologie
Hamburg, 22559
GermanySite Not Available
KRH Klinikum Siloah
Hannover, 30459
GermanySite Not Available
Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin
Jena, 07747
GermanySite Not Available
Universitatsklinikum Schleswig Holstein; Klinik fur Allgemeine Innere Medizin
Kiel, 24105
GermanySite Not Available
Synexus - Leipzig
Leipzig, 04103
GermanySite Not Available
St. Marien Krankenhaus; Med. Klinik
Ludwigshafen, 67067
GermanySite Not Available
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, 68167
GermanySite Not Available
Universitatsklinikum Munster
Münster, 48149
GermanySite Not Available
Klinikum der Universität Regensburg
Regensburg, 93053
GermanySite Not Available
Universitätsklinikum Ulm; Klinik für Innere Medizin II
Ulm, 89081
GermanySite Not Available
University General Hospital of Heraklion; Department of Ophthalmology
Heraklion, 71110
GreeceSite Not Available
University General Hospital of Heraklion; Department of Ophthalmology
Heraklon, 711 10
GreeceSite Not Available
University General Hospital of Larissa; University Gastroenterology Clinic
Larissa, 41110
GreeceSite Not Available
Iatriko Palaiou Falirou; Gastrointestinal Department
Palaio Faliro, 175 62
GreeceSite Not Available
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
Thessaloniki, 54645
GreeceSite Not Available
Synexus (DRS) - Synexus Magyarország Kft. Budapest
Budapest, 1036
HungarySite Not Available
Szent Pantaleon Korhaz-Rendelointezet; Gastroenterologiai Osztaly
Dunaújváros, 2400
HungarySite Not Available
AES - DRS - Synexus Gyula - Magyarország Egészségügyi Szolgáltató Kft
Gyula, 5700
HungarySite Not Available
Karolina Korhaz Rendelointezet; Belgyogyaszati Tipusu Matrix Egyseg -Belgyogyaszat
Mosonmagyaróvár, 9200
HungarySite Not Available
Csongrad Megyei Dr. Bugyi Istvan Korhaz; Belgyogyaszati Osztaly
Szentes, 6600
HungarySite Not Available
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; I. sz. Belgyogyaszati Osztaly
Székesfehérvár, 8000
HungarySite Not Available
Csolnoky Ferenc Kórház
Veszprém, 8200
HungarySite Not Available
Portiuncula Hospital, Ballinasloe
Co Galway,
IrelandSite Not Available
Our Lady of Lourdes Hospital, Louth
County Louth,
IrelandSite Not Available
St Vincents University Hospital
Dublin,
IrelandSite Not Available
Soroka University Medical Centre
Beer Sheva, 8410100
IsraelSite Not Available
Soroka University Medical Centre
Beer-Sheva, 84101
IsraelSite Not Available
Shaare Zedek Medical Center; Bait Vagan
Jerusalem, 9103102
IsraelSite Not Available
Meir Medical Center
Kfar Saba, 44281
IsraelSite Not Available
Meir Medical Center
Kfar- Saba, 4428164
IsraelSite Not Available
The Galilli Medical Center
Nahariyya, 22100
IsraelSite Not Available
Rabin Medical Center; PPDS; Pharmacy
Petach Tiqwa, 49100
IsraelSite Not Available
Chaim Sheba Medical Center
Ramat Gan, 5265601
IsraelSite Not Available
Kaplan Medical Center
Rehovot, 76100
IsraelSite Not Available
Chaim Sheba Medical Center
Tel Hashomer, 52661
IsraelSite Not Available
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della
Udine, Friuli-Venezia Giulia 33100
ItalySite Not Available
Complesso Integrato Columbus
Roma, Lazio 00168
ItalySite Not Available
ASST FATEBENEFRATELLI SACCO (Sacco)
Milano, Lombardia 20157
ItalySite Not Available
ASST di Monza - Azienda Ospedaliera San Gerardo; U.O. Farmacia -Settore A - Corpo Posteriore
Monza, Lombardia 20900
ItalySite Not Available
ASST Rhodense - Ospedale di Rho
Rho, Lombardia 20017
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano (MI), Lombardia 20089
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
Ancona, Marche 60020
ItalySite Not Available
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Piemonte 10128
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Firenze, Toscana 50141
ItalySite Not Available
Azienda Ospedaliera Di Padova
Padova, Veneto 35128
ItalySite Not Available
ICS ARENSIA Exploratory Medicine
Chisinau, MD-2025
Moldova, Republic ofSite Not Available
ETZ-Elisabeth; Cardiologie
Tilburg, 5022 GC
NetherlandsSite Not Available
SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
?ód?, 90-153
PolandSite Not Available
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej
Bydgoszcz, 85-168
PolandSite Not Available
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
Chojnice, 89-600
PolandSite Not Available
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Cz?stochowa, 42-202
PolandSite Not Available
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, 42-202
PolandSite Not Available
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gda?sk, 80-382
PolandSite Not Available
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdańsk, 80-382
PolandSite Not Available
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537
PolandSite Not Available
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, 40-040
PolandSite Not Available
ETG Kielce
Kielce, 25-355
PolandSite Not Available
Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej
Lublin, 20-582
PolandSite Not Available
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ, 34-400
PolandSite Not Available
Klimed Marek Klimkiewicz
Piotrków Trybunalski, 97-300
PolandSite Not Available
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Pozna?, 61-731
PolandSite Not Available
Synexus - Poznan
Poznan, 60-702
PolandSite Not Available
Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa
Poznań, 61-731
PolandSite Not Available
Gabinet Lekarski, Bartosz Korczowski
Rzeszów, 35-302
PolandSite Not Available
Endoskopia Sp. z o.o.
Sopot, 81-756
PolandSite Not Available
Sonomed Sp. z o.o.
Szczecin, 71-685
PolandSite Not Available
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Toruń, 87-100
PolandSite Not Available
Centrum Zdrowia MDM
Warszawa, 00-635
PolandSite Not Available
WIP Warsaw IBD Point Profesor Kierkus
Warszawa, 00-728
PolandSite Not Available
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
Wloclawek, 87-800
PolandSite Not Available
Melita Medical
Wroc?aw, 50-449
PolandSite Not Available
Przychodnia EuroMediCare
Wroc?aw, 50-220
PolandSite Not Available
Synexus - Wroclaw
Wroclaw, 50-088
PolandSite Not Available
EMC Instytut Medyczny S.A.
Wrocław, 50-220
PolandSite Not Available
Melita Medical
Wrocław, 50-449
PolandSite Not Available
ETG Zamosc
Zamosc, 22-400
PolandSite Not Available
Osrodek Badan Klinicznych Appletreeclinics
Łódź, 90-349
PolandSite Not Available
SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.
Łódź, 90-153
PolandSite Not Available
Moscow Regional Research Clinical Institute Na Mfvladimirskiy
Moscow, Moskovskaja Oblast 129110
Russian FederationSite Not Available
North-West State Medical University n.a. I.I. Mechnikov
Sankt-peterburg, Sankt Petersburg 191015
Russian FederationSite Not Available
Saint Martyr Elizabeth City Hospital
Sankt-peterburg, Sankt Petersburg 195257
Russian FederationSite Not Available
Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science
Irkutsk, 664033
Russian FederationSite Not Available
Kuban State Medical University
Krasnodar, 350000
Russian FederationSite Not Available
Regional Clinical Hospital
Krasnoyarsk, 660022
Russian FederationSite Not Available
Research Institute of Physiology and Basic Medicine
Novosibirsk, 630117
Russian FederationSite Not Available
Rostov State Medical University; Cardiorheumatology Department
Rostov-na-Donu, 344022
Russian FederationSite Not Available
Medical University Reaviz
Samara, 443011
Russian FederationSite Not Available
North-West State Medical University n.a. I.I. Mechnikov
St. Petersburg, 191015
Russian FederationSite Not Available
Russian Medical Military Academy n.a. S.M. Kirov
St. Petersburg, 194044
Russian FederationSite Not Available
Tomsk Regional Clinical Hospital
Tomsk, 634063
Russian FederationSite Not Available
KBC Dr Dragisa Misovic Dedinje
Belgrade, 11000
SerbiaSite Not Available
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
SerbiaSite Not Available
Clinical Center Kragujevac; Clinic Of Psychiatry
Kragujevac, 34000
SerbiaSite Not Available
Clinical Center Nis
NIS, 18000
SerbiaSite Not Available
General Hospital Vrsac
Vrsac, 26300
SerbiaSite Not Available
Clinical Hospital Centre Zemun
Zemun, 11080
SerbiaSite Not Available
General Hospital Djordje Joanovic - Zrenjanin
Zrenjanin, 23000
SerbiaSite Not Available
Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo
Las Palmas de Gran Canaria, LAS Palmas 35010
SpainSite Not Available
Hospital Universitario de Torrejon
Torrejon de Ardoz, Madrid 28850
SpainSite Not Available
Centro Medico Teknon; Servicio de Farmacia
Barcelona, 8022
SpainSite Not Available
Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007
SpainSite Not Available
Hospital Universitario de La Princesa; Aparato Digestivo
Madrid, 28006
SpainSite Not Available
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, 37007
SpainSite Not Available
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
Valencia, 46010
SpainSite Not Available
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Chernihiv Governorate 58005
UkraineSite Not Available
Medical Centre of PE First Private Clinic
Zhytomir, Crimean Regional Governmenta 10008
UkraineSite Not Available
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro, KIEV Governorate 49005
UkraineSite Not Available
Treatment and Diagnostic Center of LLC MRT Elit
Kropyvnytskyi, KIEV Governorate 25005
UkraineSite Not Available
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
Kyiv, KIEV Governorate 2091
UkraineSite Not Available
Medical Center of Edelweiss Medics LLC
Kyiv, KIEV Governorate 02002
UkraineSite Not Available
Medical Center of LLC Medical Center Dopomoga Plus
Kyiv, KIEV Governorate 02000
UkraineSite Not Available
Medical Center of LLC Medical Clinic Blagomed
Kyiv, KIEV Governorate 01001
UkraineSite Not Available
Medical Center of Limited Liability Company "Harmoniya krasy"
Kyiv, KIEV Governorate 01135
UkraineSite Not Available
Medical Center of Limited Liability Company ?Harmoniya krasy?
Kyiv, KIEV Governorate 01135
UkraineSite Not Available
Synexus Affiliate - MC of LLC Medbud-Clinic
Kyiv, KIEV Governorate 03037
UkraineSite Not Available
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
Vinnyts, KIEV Governorate 21018
UkraineSite Not Available
Ternopil University Hospital; Regional Center of Gastroenterology with Hepatology
Ternopil, Katerynoslav Governorate 46002
UkraineSite Not Available
Zaporizhia City Multispecialty Clinical Hospital #9
Zaporizhzhye, Katerynoslav Governorate 69063
UkraineSite Not Available
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
Kharkiv, Kharkiv Governorate 61037
UkraineSite Not Available
Medical Centre of LLC CARDIOCOM
Kozyn, Kharkiv Governorate 08711
UkraineSite Not Available
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
Zaporizhzhia, Kharkiv Governorate 69600
UkraineSite Not Available
Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov
Vinnytsia, Podolia Governorate 21029
UkraineSite Not Available
Medical Center of LLC Medical Center Family Medicine Clinic; Endoscopy & Gastroenterology
Dnipr, Polissya Okruha 49600
UkraineSite Not Available
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
Lviv, Polissya Okruha 79059
UkraineSite Not Available
Transcarpathian Regional Clinical Hospital n.a. A. Novak; Rheumatology Department
Uzhgorod, 88000
UkraineSite Not Available
Medical Center of Diaservice LLC; Division of clinical trials conduct, Department #3
Zaporizhzhia, 69035
UkraineSite Not Available
Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ
United KingdomSite Not Available
Synexus - Wales Clinical Research Centre
Cardiff, CF15 9SS
United KingdomSite Not Available
Kings College Hospital
London, SW9 8RR
United KingdomSite Not Available
Synexus - Manchester Clinical Research Centre
Manchester, M15 6SX
United KingdomSite Not Available
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
United KingdomSite Not Available
Care Access Research
San Pablo, California 94806
United StatesSite Not Available
QWay Research
Hialeah, Florida 33010
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Gastroenterology Group of Naples
Naples, Florida 34102
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesSite Not Available
Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesSite Not Available
Clinical Research Institute of Michigan
Chesterfield, Michigan 48047
United StatesSite Not Available
Atlantic Health System
Morristown, New Jersey 07960
United StatesSite Not Available
NYU Langone Long Island Clinical Research Associates
Great Neck, New York 11021
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
Southtowns Gastroenterology, PLLC
Orchard Park, New York 14127
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
Syracuse VA Medical Center - NAVREF; Pharmacy
Syracuse, New York 13210
United StatesSite Not Available
Carolina Digestive Diseases
Greenville, North Carolina 27834
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Gastro One
Germantown, Tennessee 38138
United StatesSite Not Available
Vanderbilt University Medical Center; IBD Clinic
Nashville, Tennessee 37212
United StatesSite Not Available
Vilo Research Group
Houston, Texas 77017
United StatesSite Not Available
Tyler Research Institute, LLC
Tyler, Texas 75701
United StatesSite Not Available
Texas Digestive Disease Consultants - PPDS
Webster, Texas 77598
United StatesSite Not Available
University of Utah; Division of Gastroenterology/Hepatology
Salt Lake City, Utah 84132
United StatesSite Not Available
The Medical College of Wisconsin Inc.
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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