An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
FIGARO UC 303
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)
2 other identifiers
interventional
366
35 countries
391
Brief Summary
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2018
Typical duration for phase_3
391 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedStudy Start
First participant enrolled
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedResults Posted
Study results publicly available
January 14, 2022
CompletedJanuary 14, 2022
December 1, 2021
3.2 years
September 6, 2017
December 16, 2021
December 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Remission Based on Composite Score at Week 52
Remission: a composite score of participant reported symptoms using daily e-diary and centrally read endoscopy as follows: stool frequency sub-score 0 or 1 with at least a 1-point change from induction study baseline; and rectal bleeding sub-score of 0; and endoscopic sub-score 0 or 1 (modified, excludes friability). The composite score was a recommended measure consisted of Mayo score without the Physician global assessment (PGA) sub-score and ranges from 0-9 points. The Mayo score was a measure of UC disease activity ranged from 0-12 points and consisted of 4 sub-scores, each graded from 0-3 with higher scores indicating more severe disease. Sub-scores were rectal bleeding (range: 0-3, where 0= no blood \& 3=blood alone passes), stool frequency (range: 0-3, where 0= normal number of stools and 3=at least 5 stools more than normal), PGA sub-score (range: 0-3- higher score= severe disease), and an endoscopic sub-score (range: 0-3, where 0= normal/inactive disease; 3= severe disease).
At Week 52
Secondary Outcomes (12)
Number of Participants With Endoscopic Remission at Week 52
At Week 52
Number of Participants With Clinical Remission at Week 52
At Week 52
Number of Participants With Sustained Remission at Week 52
At Week 52
Number of Participants With Clinical Response Based on Composite Score at Week 52
At Week 52
Number of Participants With Mucosal Healing Based on Endoscopic and Histologic Assessment at Week 52
At Week 52
- +7 more secondary outcomes
Study Arms (3)
Ontamalimab 25 mg
EXPERIMENTALParticipants will receive 25 milligram (mg) of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 25 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe once in every 4 weeks (Q4W) up to Week 52.
Ontamalimab 75 mg
EXPERIMENTALParticipants will receive 75 mg of ontamalimab or placebo and achieved a clinical response in one of the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive 75 mg of ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Placebo
PLACEBO COMPARATORParticipants will receive 25 mg or 75 mg ontamalimab or placebo matched to ontamalimab in the induction studies (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) will receive placebo matched to ontamalimab as maintenance treatment subcutaneously using a prefilled syringe Q4W up to Week 52.
Interventions
Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).
Eligibility Criteria
You may qualify if:
- Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
- Participants must have completed the 12-week induction treatment period (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
- Participants must have achieved clinical response in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]). Clinical response is defined as:
- i) A decrease from the induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) baseline in the composite score of patient reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the sub score for rectal bleeding greater than or equal to (\>=) 1 point or a sub score for rectal bleeding less than or equal to (\<=) 1 OR ii) A decrease from the induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1.
- For eligibility assessment, clinical response will be determined based on the centrally read endoscopy performed during screening and at Week 12 of induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
- \- Participants receiving any treatment(s) for ulcerative colitis (UC) are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
You may not qualify if:
- Participants who had major protocol deviation(s) (as determined by the sponsor) in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
- Participants who permanently discontinued investigational product because of an adverse event (AE), regardless of relatedness to investigational product, in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]).
- Participants who are likely to require surgery for UC during the study period.
- Participants are females who became pregnant during induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]), females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (that is \[i.e,\] highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
- Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
- Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
- Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
- Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example \[eg\], renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic \[eg, Felty's syndrome\], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
- Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction study (SHP647-301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) and who are without a generally accepted course of treatment.
- Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
- Participants who are participating in or plan to participate in other investigational studies (other than induction study SHP647- 301 \[NCT03259334\] and SHP647-302 \[NCT03259308\]) during study SHP647-303 \[NCT03290781\].
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (401)
Arizona Digestive Health Mesa - East
Mesa, Arizona, 85206, United States
Elite Clinical Studies - Phoenix - Clinedge - PPDS
Phoenix, Arizona, 85018, United States
Atria Clinical Research - Clinedge - PPDS
Little Rock, Arkansas, 72209, United States
Advanced Research Center
Anaheim, California, 92805, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
United Medical Doctors
Encinitas, California, 92024-1350, United States
University of California San Diego
La Jolla, California, 92093, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, 93534, United States
VA Long Beach Healthcare System - NAVREF - PPDS
Long Beach, California, 90822, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
United Medical Doctors
Murrieta, California, 92563, United States
Alliance Clinical Research-(Vestavia Hills)
Poway, California, 92064, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University of California San Francisco
San Francisco, California, 94158, United States
Care Access Research, San Pablo
San Pablo, California, 94806, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80903, United States
Asthma and Allergy Associates PC - CRN - PPDS
Colorado Springs, Colorado, 80907, United States
Renaissance Research Medical Group, INC
Cape Coral, Florida, 33991, United States
Gastro Florida
Clearwater, Florida, 33756, United States
Advanced Clinical Research Network
Coral Gables, Florida, 33134, United States
Alliance Medical Research LLC
Coral Springs, Florida, 33071, United States
ENCORE Borland-Groover Clinical Research - ERN - PPDS
Jacksonville, Florida, 32256, United States
SIH Research
Kissimmee, Florida, 34741, United States
Hi Tech and Global Research, LLc
Miami, Florida, 33135, United States
Nuren Medical and Research Center
Miami, Florida, 33144, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157, United States
Crystal Biomedical Research
Miami Lakes, Florida, 33065, United States
Gastroenterology Group of Naples
Naples, Florida, 34102, United States
Pharma Research International Inc
Naples, Florida, 34102, United States
Omega Research Consultants LLC - Clinedge - PPDS
Orlando, Florida, 32810, United States
Accel Research Sites - St. Petersburg - ERN - PPDS
Pinellas Park, Florida, 33781, United States
BRCR Medical Center, Inc
Plantation, Florida, 33322, United States
East Coast Institute for Research, LLC
Saint Augustine, Florida, 32086, United States
DBC Research
Tamarac, Florida, 33321, United States
Bayside Clinical Research - New Port Richey
Tampa, Florida, 33604, United States
Atlanta Gastroenterology Specialists, PC
Atlanta, Georgia, 30308, United States
Infinite Clinical Trials
Atlanta, Georgia, 30349, United States
Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS
Columbus, Georgia, 31904, United States
Atlanta Center For Gastroenterology PC
Decatur, Georgia, 30033, United States
Loretto Hospital
Chicago, Illinois, 60644, United States
IL Gastroenterology Group
Gurnee, Illinois, 60031, United States
Edward Hines Jr VA Hospital - NAVREF - PPDS
Hines, Illinois, 60141, United States
Dupage Medical Group
Oakbrook Terrace, Illinois, 60181, United States
Medisphere Medical Research Center LLC
Evansville, Indiana, 47714, United States
Laporte County Institute For Clinical Research
Michigan City, Indiana, 46360, United States
Gastroenterology Associates of Hazard
Hazard, Kentucky, 41701, United States
CroNOLA, LLC.
Houma, Louisiana, 70360, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, 70601, United States
Louisiana Research Center LLC
Shreveport, Louisiana, 71103, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Commonwealth Clinical Studies LLC
Brockton, Massachusetts, 02302, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047, United States
National Clinical, LLC
Hamtramck, Michigan, 48212, United States
Mayo Clinic Health System - PPDS
Duluth, Minnesota, 55805, United States
Digestive Health Center PA
Ocean Springs, Mississippi, 39564, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
St Louis Center For Clinical Research
St Louis, Missouri, 63128, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Encompass Care
North Las Vegas, Nevada, 89086, United States
New York Total Medical Care PC
Brooklyn, New York, 11215, United States
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, 11042, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Southtowns Gastroenterology, PLLC
Orchard Park, New York, 14127, United States
East Carolina Gastroenterology
Jacksonville, North Carolina, 28546, United States
Piedmont Healthcare
Statesville, North Carolina, 28625, United States
Consultants For Clinical Research Inc
Cincinnati, Ohio, 45219, United States
Consultants For Clinical Research Inc
Cincinnati, Ohio, 45249, United States
Consultants For Clinical Research Inc
Fairfield, Ohio, 45014, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Ohio Clinical Research Partners LLC
Mentor, Ohio, 44060, United States
Veteran's Research and Education Foundation - NAVREF - PPDS
Oklahoma City, Oklahoma, 73104, United States
Veterans Research Foundation of Pittsburgh - NAVREF - PPDS
Pittsburgh, Pennsylvania, 15240, United States
Digestive Disease Associates
Wyomissing, Pennsylvania, 19610, United States
Gastro One
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Advanced Gastroenterology-Union City
Union City, Tennessee, 38237, United States
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
Baytown, Texas, 77521, United States
Northside Gastroenterology
Cypress, Texas, 77429, United States
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
Garland, Texas, 75044, United States
Precision Research Institute, LLC
Houston, Texas, 77039, United States
Biopharma Informatic Inc.
Houston, Texas, 77043, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Aztec Medical Research
Houston, Texas, 77079, United States
BI Research Center
Houston, Texas, 77084, United States
Southern Star Research Institute LLC
San Antonio, Texas, 78229, United States
DM Clinical Research - ERN - PPDS
Tomball, Texas, 77375, United States
HP Clinical Research
Bountiful, Utah, 84010, United States
Mid Atlantic Health Specialists
Galax, Virginia, 24333, United States
Winchester Gastroenterology Associates
Winchester, Virginia, 22601-2872, United States
CHI Franciscan Digestive Care Associates
Tacoma, Washington, 98405, United States
Exemplar Research, Inc. - Elkins
Elkins, West Virginia, 26241, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Fundación Favaloro
Buenos Aires, C1093AAS, Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, Argentina
Sanatorio 9 de Julio SA
San Miguel de Tucumán, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Alfred Hospital
Box Hill, Victoria, 3128, Australia
St Vincents Hospital Melbourne - PPDS
Melbourne, Victoria, 3065, Australia
A.ö. Krankenhaus der Barmherzigen Brüder
Sankt Veit an der Glan, Carinthia, 9300, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Saint Pölten, 3100, Austria
LKH-Universitätsklinikum Klinikum Graz
Graz, Styria, 8036, Austria
Klinikum Klagenfurt Am Woerthersee
Klagenfurt, 9020, Austria
Salzburger Landeskliniken
Salzburg, 5020, Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, 4600, Austria
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
CHU Mouscron
Mouscron, 7700, Belgium
Clinical Center Banja Luka
Banja Luka, 78000, Bosnia and Herzegovina
University Multiprofile Hospital for Active Treatment Sveta Anna
Sofia, Sofia-Grad, 1750, Bulgaria
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, Sofia-Grad, 1784, Bulgaria
University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD
Pleven, 5800, Bulgaria
Multiprofile Hospital for Active Treatment Eurohospital
Plovdiv, 4004, Bulgaria
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS
Rousse, 7002, Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
Sofia, 1202, Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, 1421, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
Sofia, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
Medical Center Convex EOOD
Sofia, 1680, Bulgaria
Diagnostic Consultative Centre Mladost - M OOD
Varna, 9020, Bulgaria
Percuro Clinical Research LTD
Victoria, British Columbia, V8P 2P5, Canada
Toronto Digestive Disease Associates Inc
Toronto, Ontario, M3N 2V7, Canada
Hospital Pablo Tobón Uribe
Medellín, Antioquia, 050034, Colombia
Servimed S.A.S
Bucaramanga, Santander Department, Colombia
IPS Centro Médico Julián Coronel S.A.S. - PPDS
Cali, Colombia
University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000, Croatia
Opca Bolnica Karlovac
Karlovac, Karlovacka Županija, 47000, Croatia
Opca bolnica Bjelovar
Bjelovar, 43000, Croatia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
University Hospital Centre Split
Split, 21000, Croatia
General Hospital Virovitica
Virovitica, 33000, Croatia
General County Hospital Vukovar and Croatian Veterans Hospital
Vukovar, 32000, Croatia
General Hospital Zadar
Zadar, 23 000, Croatia
Hepato-Gastroenterologie HK, s. r. o.
Hradec Králové, Královéhradecký kraj, 500 12, Czechia
PreventaMed s.r.o.
Olomouc, Olomoucký kraj, 779 00, Czechia
Institut Klinicke A Experimentalni Mediciny
Prague, 140 21, Czechia
ISCARE I.V.F. a.s.
Prague, 170 00, Czechia
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice
Ústi Nad Orlici, 562 18, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.
Ústí nad Labem, 401 13, Czechia
East Viru Central Hospital
Kohta-Järve, 31025, Estonia
OÜ LV Venter
Pärnu, 80010, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Universitätsklinikum der RWTH Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Gastro Campus Research GbR
Münster, North Rhine-Westphalia, 48159, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
Universitatsklinikum Jena
Jena, Thuringia, 07747, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Gastroenterologische Facharztpraxis am Mexikoplatz
Berlin-Zehlendorf, 14163, Germany
Sana Klinikum Biberach
Biberach an der Riss, 88400, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60596, Germany
Asklepios Westklinikum Hamburg Ggmbh
Hamburg, 22559, Germany
Klinikum rechts der Isa der Technischen Universitaet Muenchen
Munich, 81675, Germany
Ippokrateio General Hospital of Athens
Athens, Attica, 11527, Greece
University General Hospital of Patras
Pátrai, 26504, Greece
Theageneio Anticancer Oncology Hospital of Thessaloniki
Thessaloniki, 54007, Greece
Euromedica - PPDS
Thessaloniki, 54645, Greece
Bekes Megyei Kozponti Korhaz
Békéscsaba, 5600, Hungary
Magyar Honvédség Egészségügyi Központ
Budapest, 1062, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, 1136, Hungary
ENDOMEDIX Kft.
Budapest, 1139, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Bekes Megyei Kozponti Korhaz
Gyula, 5700, Hungary
Mohacsi Korhaz
Mohács, 7700, Hungary
Tolna Megyei Balassa János Kórház
Szekszárd, 7100, Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, 6600, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
Jávorszky Ödön Kórház
Vác, 2600, Hungary
Csolnoky Ferenc Korhaz
Veszprém, 8200, Hungary
St Vincent's University Hospital
Dublin, Ireland
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center - PPDS
Jerusalem, 91120, Israel
Galilee Medical Center
Nahariya, 22100, Israel
Nazareth EMMS Hospital
Nazareth, 16100, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 6423906, Israel
Baruch Padeh Poriya Medical Center
Tiberias, 15208, Israel
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Apulia, 71013, Italy
Azienda Ospedaliera Mater Domini Di Catanzaro
Catanzaro, Calabria, 88100, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, Emilia-Romagna, 40138, Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, Emilia-Romagna, 41124, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00152, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, 37024, Italy
Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino
Padua, Veneto, 35128, Italy
A.O.U. Maggiore della Carità
Novara, 28100, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, 27100, Italy
La Sapienza-Università di Roma-Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario A Gemelli
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128, Italy
Sapporo Medical University Hospital
Sapporo, Hokkaidô, 060-8543, Japan
Medical Corporation Aoyama Clinic
Kobe, Hyôgo, 650-0015, Japan
Hyogo College of Medicine
Nishinomiya-shi, Hyôgo, 663-8501, Japan
Sagamihara Kyodo Hospital
Sagamihara, Kanagawa, 252-5188, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 343-8555, Japan
Nihonbashi Egawa Clinic
Chuo-Ku, Tokyo, 103-0028, Japan
Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
Ome Municipal General Hospital
Ōme, Tokyo, 198-0042, Japan
Tokatsu Tsujinaka Hospital
Abiko, 270-1166, Japan
Kunimoto Hospital
Asahikawa, 070-0061, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Hakodate Koseiin Hakodate Goryoukaku Hospital
Hakodate, 040-0001, Japan
Yuai Memorial Hospital
Koga, 306-0232, Japan
Kawabe Clinic
Koganei, 184-0003, Japan
Hidaka Coloproctology Clinic
Kurume-shi, 839-0809, Japan
Aizawa Hospital
Matsumoto-shi, 390-0814, Japan
Aichi Medical University Hospital
Nagakute, 480-1195, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya, 663-8014, Japan
Onomichi General Hospital
Onomichi, Japan
Chiinkai Dojima General & Gastroenterology Clinic
Osaka, 530-0003, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, 870-0823, Japan
Shiga University of Medical Science Hospital
Ōtsu, 520-2192, Japan
Bellland General Hospital
Sakai, 599-8247, Japan
Toho University Sakura Medical Center
Sakura, 285-8741, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
Sapporo Tokushukai Hospital
Sapporo, 065-0033, Japan
Tohoku Rosai Hospital
Sendai, 981-8563, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, 321-0293, Japan
Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital
Takatsuki, 569-0086, Japan
Koukokukai Ebisu Clinic
Tokyo, 150-0013, Japan
Shinbeppu Hospital
Beppu, Ôita, 874-0833, Japan
Yodogawa Christian Hospital
Osaka, Ôsaka, 533-0024, Japan
Rafik Hariri University Hospital
Beirut, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, LT- 08661, Lithuania
Vilnius City Clinical Hospital
Vilnius, LT-10207, Lithuania
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, Morelos, 62170, Mexico
JM Research S.C
Cuernavaca, Morelos, 62290, Mexico
Unidad de Atencion Medica e Investigacion en Salud
Mérida, Yucatán, 97000, Mexico
Centro de Investigación Médica Aguascalientes
Aguascalientes, 20116, Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, 54769, Mexico
Centro de Investigacion Clinica Acelerada, S.C.
Distrito Federal, 07020, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
Accelerium, S. de R.L. de C.V.
Monterrey, 64000, Mexico
Clinical Research Institute
Tlalnepantla, 54055, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, 45030, Mexico
ETZ-Elisabeth
Tilburg, North Brabant, 5022 GC, Netherlands
NWZ, location Alkmaar
Alkmaar, North Holland, 1815 JD, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333 ZA, Netherlands
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Academisch Medisch Centrum Amsterdam
Amsterdam, 1105 AZ, Netherlands
Auckland City Hospital
Grafton, Auckland, 1023, New Zealand
Dunedin Hospital
Dunedin, South Island, 9016, New Zealand
Wellington Hospital
Newtown, Wellington Region, 6021, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Vitamed Galaj i Cichomski sp.j.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-079, Poland
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland
Krakowskie Centrum Medyczne
Krakow, Lesser Poland Voivodeship, 31-501, Poland
Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449, Poland
Lexmedica
Wroclaw, Lower Silesian Voivodeship, 53-114, Poland
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
Lódz, Lódzkie, 90-302, Poland
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Lódz, Lódzkie, 90-647, Poland
Instytut Centrum Zdrowia Matki Polki
Lódz, Lódzkie, 93-338, Poland
BioVirtus Centrum Medyczne
Józefów, Masovian Voivodeship, 05-410, Poland
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED
Warsaw, Masovian Voivodeship, 03-580, Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, Masovian Voivodeship, 04-749, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Endoskopia Sp. z o.o.
Sopot, Pomeranian Voivodeship, 81-756, Poland
Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach
Katowice, Silesian Voivodeship, 40-211, Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796, Poland
Centrum Medyczne Czestochowa - PRATIA - PPDS
Częstochowa, 42-200, Poland
Centrum Medyczne Gdynia - PRATIA - PPDS
Gdynia, 81-338, Poland
NZOZ All Medicus
Katowice, 40-659, Poland
Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska
Krakow, 31-315, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054, Poland
Med Gastr Sp.z.o.o Sp.k
Lodz, 91-034, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
Centrum Innowacyjnych Terapii
Piaseczno, 05-500, Poland
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
Poznan, 60-856, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Bandurskiego 98/U12
Szczecin, 71-685, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
H-T. Centrum Medyczne Endoterapia
Tychy, 43-100, Poland
Centrum Zdrowia MDM
Warsaw, 00-635, Poland
Centrum Medyczne Warszawa - PRATIA - PPDS
Warsaw, 01-868, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Zamość, 22-400, Poland
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
Gmina Końskie, Świętokrzyskie Voivodeship, 26-200, Poland
Hospital da Luz
Lisbon, Lisbon District, 1500-650, Portugal
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar do Algarve - Hospital de Portimao
Faro, 8000-385, Portugal
Hospital Senhora da Oliveira - Guimaraes, E.P.E
Guimarães, 4835-044, Portugal
Hospital de São Bernardo
Setúbal, 2910-446, Portugal
Cluj-Napoca Emergency Clinical County Hospital
Cluj-Napoca, Cluj, 400006, Romania
Dr.Carol Davila Emergency University Central Military Hospital
Bucharest, 010825, Romania
Sana Monitoring SRL
Bucharest, 011025, Romania
Colentina Clinical Hospital
Bucharest, 020125, Romania
Prof. Dr. Matei Bals Institute of Infectious Diseases
Bucharest, 021105, Romania
Fundeni Clinical Institute
Bucharest, 022328, Romania
Centrul Medical Hifu Terramed Conformal S.R.L.
Bucharest, 031864, Romania
Affidea Romania SRL
Constanța, RO-900591, Romania
Gastromedica SRL
Iași, 700506, Romania
Dr. Tirnaveanu Amelita Private Practice
Oradea, 410066, Romania
Dr. Goldis Gastroenterology Center SRL
Timișoara, 300002, Romania
Kazan State Medical University
Kazan', 420097, Russia
Moscow Clinical Scientific Center
Moscow, 111123, Russia
Moscow Regional Research Clinical Institute Na Mfvladimirskiy
Moscow, 129110, Russia
Nizhegorodskaya Regional Clinical Hospital n.a. Semashko
Nizhny Novgorod, 603126, Russia
Research Institute of Physiology and Basic Medicine
Novosibirsk, 630117, Russia
Rostov State Medical University
Rostov-on-Don, 344022, Russia
Rostov State Medical University
Rostov-on-Don, 344091, Russia
St. Elizabeth Municipal Clinical Hospital
Saint Petersburg, 195257, Russia
First St. Petersburg State Medical University n.a. I.P Pavlov
Saint Petersburg, 197022, Russia
Union Clinic, LLC
Saint Petersburg, 197110, Russia
Russian Medical Military Academy n.a. S.M. Kirov
Saint Petersburg, Russia
Medical University Reaviz
Samara, 443011, Russia
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
Samara, 443029, Russia
Medical Company Hepatolog, LLC
Samara, 443063, Russia
SHI Regional Clinical Hospital
Saratov, 410012, Russia
Smolensk Regional Clinical Hospital
Smolensk, 214018, Russia
Stavropol State Medical University
Stavropol, 355017, Russia
Regional Consulting and Diagnostics Centre
Tyumen, 625026, Russia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
University Clinical Center Nis
Niš, 18000, Serbia
General Hospital Vrsac
Vršac, 26300, Serbia
University Clinical Center Kragujevac
Kragujevac, Šumadijski Okrug, 34000, Serbia
Univerzitna nemocnica Bratislava
Bratislava, 851 07, Slovakia
KM Management, spol. s r.o.
Nitra, 949 01, Slovakia
Gastro LM, s.r.o.
Prešov, 080 01, Slovakia
CLINRESCO, ARWYP Medical Suites
Johannesburg, Gauteng, 1619, South Africa
Dr. J Breedt
Pretoria, Gauteng, 0002, South Africa
Dr JP Wright
Claremont, Western Cape, 7708, South Africa
Kyungpook National University Hospital
Daegu, Daegu Gwang'yeogsi, 41944, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gang'weondo, 26426, South Korea
CHA Bundang Medical Center, CHA University
Seongnam, Gyeonggido, 13496, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggido, 16247, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 702-210, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, 03722, South Korea
Asan Medical Center - PPDS
Seoul, 05505, South Korea
Samsung Medical Center PPDS
Seoul, 06351, South Korea
Inje University Seoul Paik Hospital
Seoul, 100-032, South Korea
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba, 14004, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Centro Medico Teknon - Grupo Quironsalud
Barcelona, 08022, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Universität Zürich
Zurich, Zürich (de), 8091, Switzerland
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33169, Turkey (Türkiye)
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
Chernivtsi, Chernivtsi Oblast, 58001, Ukraine
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
Kyiv, Kyïv, 04107, Ukraine
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council
Zaporizhzhia, Zaporizhzhia Oblast, 69005, Ukraine
ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council
Dnipro, 49005, Ukraine
LLC Medical Center Family Medicine Clinic
Dnipro, 49038, Ukraine
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipro, 49074, Ukraine
Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine
Kharkiv, 61039, Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, 61058, Ukraine
MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection
Kharkiv, 61166, Ukraine
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
Kherson, 73000, Ukraine
Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council
Kryvyi Rih, 50056, Ukraine
Medical Center of LLC Medical Clinic Blagomed
Kyiv, 01023, Ukraine
Kyiv City Clinical Hospital #18
Kyiv, 01030, Ukraine
Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy"
Kyiv, 01033, Ukraine
Municipal Institution of KRC Kyiv Regional Hospital #2
Kyiv, 04073, Ukraine
Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway
Lviv, 79007, Ukraine
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
Lviv, 79059, Ukraine
Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council
Odesa, 65025, Ukraine
MNPE Central City Clinical Hospital of Uzhhorod City Council
Uzhhorod, 88000, Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsia, 21009, Ukraine
Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC
Vinnytsia, 21018, Ukraine
Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1
Vinnytsia, 21029, Ukraine
MNPE City Hospital No. 6 of Zaporizhzhia City Council
Zaporizhzhia, 69035, Ukraine
Aberdeen Royal Infirmary - PPDS
Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom
Fairfield General Hospital - PPDS
Lancashire, Bury, BL9 7TD, United Kingdom
Whipps Cross University Hospital
London, London, City of, E11 1NR, United Kingdom
North Tyneside General Hospital
North Shields, Northumberland, NE29 8NH, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, SY3 8XQ, United Kingdom
Western General Hospital Edinburgh - PPDS
Edinburh, EH4 2XU, United Kingdom
Royal Gwent Hospital - PPDS
Newport, NP20 2UB, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
Vermeire S, Danese S, Sandborn WJ, Schreiber S, Hanauer S, D'Haens G, Nagy P, Thakur M, Bliss C, Cataldi F, Goetsch M, Gorelick KJ, Reinisch W. Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease. J Crohns Colitis. 2024 May 31;18(5):708-719. doi: 10.1093/ecco-jcc/jjad199.
PMID: 38096402DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Shire
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2017
First Posted
September 25, 2017
Study Start
April 4, 2018
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
January 14, 2022
Results First Posted
January 14, 2022
Record last verified: 2021-12