Study Stopped
Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.
Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)
CARMEN CD 307
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)
2 other identifiers
interventional
40
32 countries
273
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2019
Typical duration for phase_3
273 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
July 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedStudy Start
First participant enrolled
February 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2021
CompletedResults Posted
Study results publicly available
March 31, 2022
CompletedMarch 31, 2022
March 1, 2022
2.4 years
July 24, 2018
March 3, 2022
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Clinical Remission 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
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 Outcomes (7)
Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 52
At Week 52
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52
At Week 52
Number of Participants With Clinical Remission Defined by Crohn's Disease (CD) E-diary Sub-scores- at Week 52
At Week 52
Number of Participants With Sustained Clinical Remission at Week 52
At Week 52
Number of Participants With Sustained Enhanced Endoscopic Response at Week 52
At Week 52
- +2 more secondary outcomes
Study Arms (3)
Ontamalimab 25 mg
EXPERIMENTALParticipants 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 \[NCT03566823\]).
Ontamalimab 75 mg
EXPERIMENTALParticipants 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 \[NCT03566823\]).
Placebo
PLACEBO COMPARATORParticipants 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 \[NCT03566823\]).
Interventions
SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.
SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 \[g/dL\]).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (281)
Arizona Digestive Health Mesa - East
Mesa, Arizona, 85206, United States
Elite Clinical Studies - Phoenix - Clinedge - PPDS
Phoenix, Arizona, 85018, United States
CATS Research Center - University of Arizona
Tucson, Arizona, 85724, 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
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, 93534, United States
Alliance Clinical Research-(Vestavia Hills)
Poway, California, 92064, United States
Inland Empire Liver Foundation
Rialto, California, 92377, 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
SIH Research
Kissimmee, Florida, 34741, United States
Hi Tech and Global Research, LLc
Miami, Florida, 33135, 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, 34110, 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
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
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
Laporte County Institute For Clinical Research
Michigan City, Indiana, 46360, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606, 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
DelRicht Clinical Research, LLC - ClinEdge - PPDS
New Orleans, Louisiana, 70115, United States
Louisiana Research Center LLC
Shreveport, Louisiana, 71103, United States
Commonwealth Clinical Studies LLC
Brockton, Massachusetts, 02302, United States
Winchester Gastroenterology Associates
Winchester, Massachusetts, 22601, 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
Gastroenterology Associates of Western Michigan, PLC
Wyoming, Michigan, 49519, United States
Mayo Clinic Health System - PPDS
Duluth, Minnesota, 55805, United States
Minnesota Gastroenterology PA
Saint Paul, Minnesota, 55114, United States
Washington University in St. Louis
St Louis, Missouri, 63110, 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
Great Neck, New York, 11021, United States
Southtowns Gastroenterology, PLLC
Orchard Park, New York, 14127, 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
Penn State Hershey Medical Group
State College, Pennsylvania, 16803, 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, 38261, 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
BI Research Center
Houston, Texas, 77084, United States
Southern Star Research Institute LLC
San Antonio, Texas, 78229, United States
Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
Webster, Texas, 77598, United States
HP Clinical Research
Bountiful, Utah, 84010, United States
Mid Atlantic Health Specialists
Galax, Virginia, 24333, United States
Fundación Favaloro
Buenos Aires, C1093AAS, Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
St Vincents Hospital Melbourne - PPDS
Fitzroy, Victoria, 3065, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
LKH-Universitätsklinikum Klinikum Graz
Graz, Styria, 8036, Austria
Klinikum Wels-Grieskirchen GmbH
Vienna, Vienna, A-1090, Austria
Salzburger Landeskliniken
Salzburg, 5020, Austria
Medizinische Universitat Wien (Medical University of Vienna)
Vienna, 1090, Austria
Academisch Medisch Centrum Amsterdam
Bonheiden, Antwerpen, 2820, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
CHU Mouscron
Mouscron, 7700, Belgium
Clinical Center Banja Luka
Banja Luka, 78000, Bosnia and Herzegovina
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
Sofia, Sofia-Grad, 1784, Bulgaria
Multiprofile Hospital for Active Treatment Eurohospital
Plovdiv, 4004, Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
Sofia, 1202, 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 Excelsior OOD - PPDS
Sofia, 1632, Bulgaria
Medical Center Convex EOOD
Sofia, 1680, Bulgaria
Diagnostic Consultative Centre Mladost - M OOD
Varna, 9000, Bulgaria
Fundación Valle Del Lili
Cali, Valle del Cauca Department, 760026, Colombia
IPS Centro Médico Julián Coronel S.A.S. - PPDS
Cali, Colombia
University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000, Croatia
Opca bolnica Bjelovar
Bjelovar, 43000, Croatia
Clinical Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital Virovitica
Virovitica, 33000, Croatia
OÜ LV Venter
Pärnu, 80010, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Klinikum rechts der Isa der Technischen Universitaet Muenchen
Munich, Bavaria, 81675, 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
Ippokrateio General Hospital of Athens
Athens, Attica, 11527, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
Iatriko Palaiou Falirou
Paliao Faliro, 17562, Greece
University General Hospital of Patras
Pátrai, 26504, 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, 1135, Hungary
ENDOMEDIX Kft.
Budapest, 1139, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Mohacsi Korhaz
Mohács, 7700, Hungary
Tolna Megyei Balassa János Kórház
Szekszárd, 7100, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000, Hungary
St Vincent's University Hospital
Dublin, 4, Ireland
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center - PPDS
Jerusalem, 91120, Israel
Galilee Medical Center
Nahariya, 22100, Israel
Baruch Padeh Poriya Medical Center
Tiberias, 15208, Israel
Azienda Ospedaliera Mater Domini Di Catanzaro
Catanzaro, Calabria, 88100, Italy
Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, Emilia-Romagna, 41100, Italy
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, 37024, 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
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, 10126, 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
Jikei University Hospital
Minato-ku, Tokyo, 105-8471, Japan
Ome Municipal General Hospital
Ōme, Tokyo, 198-0042, Japan
Kunimoto Hospital
Asahikawa, 070-0061, Japan
Hidaka Coloproctology Clinic
Kurume-shi, 839-0809, 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
Yodogawa Christian Hospital
Osaka, 533-0024, Japan
Shiga University of Medical Science Hospital
Ōtsu, 520-2192, 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
Dokkyo Medical University Hospital
Shimotsuga-gun, 321-0293, Japan
Nihonbashi Egawa Clinic
Tokyo, 103-0028, Japan
Colo-Proctology Center Matsushima Clinic
Yokohama, 220-0045, Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, Ôita, 870-0823, Japan
Al Zahraa University Hospital
Beirut, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Vilnius University Hospital Santaros Klinikos
Vilnius, LT- 08661, Lithuania
Vilnius City Clinical Hospital
Vilnius, LT-10207, Lithuania
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, 45030, Mexico
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, Morelos, 62170, Mexico
JM Research S.C
Cuernavaca, Morelos, 62290, Mexico
Accelerium, S. de R.L. de C.V.
Monterrey, Nuevo León, 64000, Mexico
Unidad de Atencion Medica e Investigacion en Salud
Mérida, Yucatán, 97000, Mexico
Centro de Investigacion Clinica Acelerada, S.C.
Distrito Federal, 07020, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000, Mexico
ETZ-Elisabeth
Tilburg, North Brabant, 5022 GC, Netherlands
NWZ, location Alkmaar
Den Helder, North Holland, 1782 GZ, Netherlands
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
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
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Lódz, Lódzkie, 90-647, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, 02-781, 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
Twoja Przychodnia - Szczecinskie 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 Czestochowa - PRATIA - PPDS
Częstochowa, 42-200, Poland
Centrum Medyczne Gdynia - PRATIA - PPDS
Gdynia, 81-338, Poland
NZOZ All Medicus
Katowice, 40-660, Poland
Med Gastr Sp.z.o.o Sp.k
Lodz, 91-034, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, 67-100, Poland
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
Poznan, 60-848, Poland
Centrum Medyczne Warszawa - PRATIA - PPDS
Rzeszów, 35-068, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
Centrum Zdrowia M D M
Warsaw, 00-635, Poland
Centralny Szpital Kliniczny MSW
Warsaw, 02-507, Poland
BioVirtus Centrum Medyczne
Warsaw, 02-797, 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 Senhora da Oliveira - Guimaraes, E.P.E
Guimarães, 4835-044, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Centro Hospitalar do Algarve - Hospital de Portimao
Portimão, 8500-338, Portugal
Sana Monitoring SRL
Bucharest, București, 011025, Romania
Cluj-Napoca Emergency Clinical County Hospital
Cluj-Napoca, Cluj, 400006, Romania
Dr.Carol Davila Emergency University Central Military Hospital
Bucharest, 010825, 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
Emergency University Hospital
Bucharest, 050098, 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
Rostov State Medical University
Rostov-on-Don, 344091, Russia
St. Elizabeth Municipal Clinical Hospital
Saint Petersburg, 195067, 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
SHI Regional Clinical Hospital
Saratov, 410012, Russia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
University Clinical Center Nis
Niš, 18000, Serbia
General Hospital Vrsac
Vršac, 26300, Serbia
Clinical Hospital Center Zemun
Zemun, Serbia
University Clinical Center Kragujevac
Kragujevac, Šumadijski Okrug, 34000, Serbia
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, 0084, South Africa
Dr JP Wright
Claremont, Western Cape, 7708, South Africa
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
Kyungpook National University Hospital
Daegu, 41944, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 702-210, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Inje University Seoul Paik Hospital
Seoul, 04551, South Korea
C.H. Regional Reina Sofia - PPDS
Córdoba, Córdoba, 14004, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Madrid, Communidad Delaware, 28007, 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 Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
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
LLC Medical Center Family Medicine Clinic
Dnipro, 49038, Ukraine
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, 61058, Ukraine
Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
Kherson, 73000, Ukraine
Medical Center of LLC Medical Clinic Blagomed
Kyiv, 01023, Ukraine
Medical Center OK!Clinic+LLC International Institute of Clinical Research
Kyiv, 02091, Ukraine
Medical Center of LLC Medical Center Dopomoga-Plus
Kyiv, 02132, Ukraine
Municipal Institution of KRC Kyiv Regional Hospital #2
Kyiv, 04073, Ukraine
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
Lviv, 79059, 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
North Tyneside General Hospital
North Shields, Northumberland, NE29 8NH, United Kingdom
Aberdeen Royal Infirmary - PPDS
Aberdeen, AB25 2ZN, 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)
Limitations and Caveats
The study was closed early as the sponsor discontinued the ontamalimab clinical trial program in CD for reasons unrelated to safety or efficacy.
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
July 24, 2018
First Posted
August 13, 2018
Study Start
February 6, 2019
Primary Completion
June 21, 2021
Study Completion
September 13, 2021
Last Updated
March 31, 2022
Results First Posted
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.