A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified April 2024 by Shire
Sponsor
Shire
Information Provided by (Responsible Party)
Shire
Clinicaltrials.gov Identifier
NCT03283085
Other Study ID Numbers:
SHP647-304
First Submitted
September 11, 2017
First Posted
September 13, 2017
Results First Posted
May 23, 2024
Last Update Posted
June 20, 2024
Last Verified
April 2024

ClinicalTrials.gov processed this data on May 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Crohn's DiseaseUlcerative Colitis
Drug: 25 mg OntamalimabDrug: 25 mg OntamalimabDrug: 75 mg OntamalimabDrug: 25 mg OntamalimabDrug: 25 mg OntamalimabDrug: 75 mg Ontamalimab

Study Design

Study TypeInterventional
Actual Enrollment557 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Study Start DateFebruary 26, 2018
Actual Primary Completion DateDecember 12, 2023
Actual Study Completion DateDecember 12, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Ulcerative Colitis (UC): Ontamalimab 25 mg
Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.
Drug: 25 mg Ontamalimab
Ontamalimab SC solution for injection
UC: Ontamalimab 25mg then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
Drug: 25 mg Ontamalimab
Ontamalimab SC solution for injection
UC: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Drug: 75 mg Ontamalimab
Ontamalimab SC solution for injection
Crohn's disease (CD): Ontamalimab 25 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.
Drug: 25 mg Ontamalimab
Ontamalimab SC solution for injection
CD: Ontamalimab 25mg then 75 mg
Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.
Drug: 25 mg Ontamalimab
Ontamalimab SC solution for injection
CD: Ontamalimab 75 mg
Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.
Drug: 75 mg Ontamalimab
Ontamalimab SC solution for injection

Outcome Measures

Primary Outcome Measures
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs (TEAEs) were defined as AEs with start dates or worsening dates at the time of or following the first exposure to investigational product.
  2. Number of Participants With Serious Infections
    Serious infections were defined as any infections that were life-threatening or those requiring hospitalization or intravenous antibiotics based on the investigator's assessment.
  3. Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time
    Clinical laboratory assessments included hematology, serum chemistry and urinalysis. Any notable changes in the clinical laboratory value over time based on the investigator interpretation were reported.
  4. Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time
    ECG included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals parameters measurement. Any discernible changes in the ECG value over time based on investigator interpretation were reported.
  5. Number of Participants With Discernible Changes in Vital Signs Over Time
    Vital sign assessments included blood pressure, pulse, respiratory rate, and temperature. Any discernible changes in vital signs over time per investigator interpretation were reported.
Secondary Outcome Measures
  1. Number of Participants With Ulcerative Colitis With Treatment Response Over Time
    Treatment response over time was defined as clinical composite score that has decreased by greater than or equal to (≥2) points and ≥30 percentage (%), with an accompanying decrease in the sub score for rectal bleeding (RB) ≥1 point or a subscore for RB ≤ 1, and/or composite score that has decreased by ≥30% and ≥3 points compared to the baseline value for induction studies. The clinical composite score is a measure consisting of sub scores RB (0-3) plus stool frequency (0-3) with higher scores indicating more severe disease. With the implementation of amendment 4 of the protocol the study became a single arm study with all participants receiving the 75 mg dose of ontamalimab. Hence, only those UC participants who were receiving the 75 mg dose of ontamalimab every 4 weeks and participating in amendment 4 of the protocol were analyzed in this outcome measure.
  2. Number of Participants With Crohn's Disease With Treatment Response Over Time
    Treatment response over time=Crohn's Disease Activity Index(CDAI)score that has decreased ≥100 points and/or simple endoscopic score for Crohn's disease(SES-CD)that has decreased by ≥25%,both compared to baseline value for induction studies.SES-CD is simple scoring system with 4 endoscopic variables measured in same 5 ileocolonic segments as CD index of severity. Overall values on SES-CD range from 0-56,higher values=more severe disease.4 endoscopic variables are scored from 0-3 in each bowel segment:ileum,right/transverse/left colon,rectum. Presence \& size of ulcers(none=0;diameter 0.1-0.5centimeter(cm)=1;0.5-2cm=2;\>2cm=3);extent of ulcerated surface(none=0;\<10%=1;10%-30%=2; \>30%= 3);extent of affected surface(none=0;\<50%=1;50%-75%=2;\>75%=3);Presence \& type of narrowing (none=0;single can be passed=1;multiple can be passed=2;cannot be passed=3).

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Participants with Ulcerative Colitis (UC):
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 been enrolled previously in study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303, completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303 (NCT03290781), had responded to ontamalimab treatment (in the induction and/or maintenance studies), and meet one of the following criteria: a. Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction studies and fulfilled the maintenance study response criteria, OR b. Participants have received ontamalimab at the maintenance study ET or Week 52 visit: i) Clinical composite score that has decreased by \>or=2 points and \>or=30%, with an accompanying decrease in the subscore for RB \>or=1 point or a subscore for RB \<or=1, compared to the baseline value for induction studies, and/or ii) Composite score that has decreased by \>or=30% and \>or=3 points compared to the baseline value for induction studies.
Participants receiving any treatment(s) for UC are eligible provided they have been on a stable dose for the designated period of time. Participants with Crohn's Disease:
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 been enrolled previously in Study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307 (NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had responded to ontamalimab treatment (in the induction or maintenance studies) and meet one of the following criteria: 1. Participants are on placebo at the maintenance study ET or Week 52 visit: they received ontamalimab in the induction study and fulfilled the maintenance study response criteria, OR 2. Participants have received ontamalimab at the maintenance study ET or Week 52 visit: i) CDAI score that has decreased by \>or=100 points at EOT visit compared to the baseline value for induction studies, and/or ii) SES-CD that has decreased by \>or=25% compared to the baseline value for induction studies.
Participants receiving any treatment(s) for CD are eligible provided they have been on a stable dose for the designated period of time.
Exclusion Criteria
Participants with UC:
Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-301, SHP647-302, or SHP647-303.
Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-301, SHP647-302, or SHP647-303.
Participants who are likely to require major surgery for UC.
Participants are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, 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 using appropriate contraception methods (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 \[e.g.\], renal, hepatic, hematologic, gastrointestinal \[except disease under study\], endocrine, cardiovascular, pulmonary, immunologic \[e.g. Felty's syndrome\], 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 study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have been advised to require treatment for latent or active disease, but 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 other investigational studies (other than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304. Participants with Crohn's Disease:
Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305, SHP647-306 or SHP647-307.
Participants who permanently discontinued investigational product because of an adverse events (AE), regardless of relatedness to investigational product, in study SHP647-305, SHP647-306 or SHP647-307.
Participants who are likely to require major surgery for CD or developed acute severe complications of CD (with or without fulfilling the treatment failure criteria in the maintenance study) that required immediate intervention (e.g. need for immediate biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI) score more than (\>) 450.
Participants are females who became pregnant during study SHP647-305, SHP647-306 or SHP647-307, 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 appropriate contraception methods (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.

Contacts and Locations

Sponsors and CollaboratorsShire
Locations
Arizona Digestive Health Mesa - East | Mesa Arizona, United States, 85206Elite Clinical Studies - Phoenix - Clinedge - PPDS | Phoenix Arizona, United States, 85018Arizona Digestive Health | Sun City Arizona, United States, 85351CATS Research Center - University of Arizona | Tucson Arizona, United States, 85724Atria Clinical Research - Clinedge - PPDS | Little Rock Arkansas, United States, 72209Advanced Research Center | Anaheim California, United States, 92805Kindred Medical Institute for Clinical Trials, LLC | Corona California, United States, 92879United Medical Doctors | Encinitas California, United States, 92024-1350University of California San Diego | La Jolla California, United States, 92093OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster California, United States, 93534Tibor Rubin VA Medical Center - NAVREF | Long Beach California, United States, 90822VA Long Beach Healthcare System - NAVREF - PPDS | Long Beach California, United States, 90822Facey Medical Foundation | Mission Hills California, United States, 91345United Medical Doctors | Murrieta California, United States, 92563Alliance Clinical Research-(Vestavia Hills) | Poway California, United States, 92064Inland Empire Liver Foundation | Rialto California, United States, 92377University of California San Francisco | San Francisco California, United States, 94158Care Access Research, San Pablo | San Pablo California, United States, 94806Peak Gastroenterology Associates | Colorado Springs Colorado, United States, 80903Asthma and Allergy Associates PC - CRN - PPDS | Colorado Springs Colorado, United States, 80907Renaissance Research Medical Group, INC | Cape Coral Florida, United States, 33991Gastro Florida | Clearwater Florida, United States, 33756Advanced Clinical Research Network | Coral Gables Florida, United States, 33134Alliance Medical Research LLC | Coral Springs Florida, United States, 33071ENCORE Borland-Groover Clinical Research - ERN - PPDS | Jacksonville Florida, United States, 32256SIH Research | Kissimmee Florida, United States, 34741Hi Tech and Global Research, LLc | Miami Florida, United States, 33135Nuren Medical and Research Center | Miami Florida, United States, 33144Sanchez Clinical Research, Inc | Miami Florida, United States, 33157Advanced Clinical Research Network | Miami Florida, United States, 33174Crystal Biomedical Research | Miami Lakes Florida, United States, 33065Gastroenterology Group of Naples | Naples Florida, United States, 34102Pharma Research International Inc | Naples Florida, United States, 34110Bayside Clinical Research - New Port Richey | New Port Richey Florida, United States, 34655Omega Research Consultants LLC - Clinedge - PPDS | Orlando Florida, United States, 32810Accel Research Sites - St. Petersburg - ERN - PPDS | Pinellas Park Florida, United States, 33781BRCR Medical Center, Inc | Plantation Florida, United States, 33322East Coast Institute for Research, LLC | Saint Augustine Florida, United States, 32086DBC Research | Tamarac Florida, United States, 33321Gastrointestinal Diseases, Inc Research - IACT- HyperCore - PPDS | Columbus Georgia, United States, 31904Atlanta Center For Gastroenterology PC | Decatur Georgia, United States, 30033Infinite Clinical Trials | Morrow Georgia, United States, 30260Atlanta Gastroenterology Specialists, PC | Suwanee Georgia, United States, 30024Loretto Hospital | Chicago Illinois, United States, 60644IL Gastroenterology Group | Gurnee Illinois, United States, 60041Edward Hines Jr VA Hospital - NAVREF - PPDS | Hines Illinois, United States, 60141Dupage Medical Group | Oakbrook Terrace Illinois, United States, 60181Medisphere Medical Research Center LLC | Evansville Indiana, United States, 47714Laporte County Institute For Clinical Research | Michigan City Indiana, United States, 46360Cotton O'Neil Clinical Research Center | Topeka Kansas, United States, 66606Gastroenterology Associates of Hazard | Hazard Kentucky, United States, 41701CroNOLA, LLC. | Houma Louisiana, United States, 70360Clinical Trials of SWLA LLC | Lake Charles Louisiana, United States, 70601DelRicht Clinical Research, LLC - ClinEdge - PPDS | New Orleans Louisiana, United States, 70115Louisiana Research Center LLC | Shreveport Louisiana, United States, 71103Chevy Chase Clinical Research | Chevy Chase Maryland, United States, 20815Commonwealth Clinical Studies LLC | Brockton Massachusetts, United States, 02302UMass Memorial Medical Center | Worcester Massachusetts, United States, 01655University of Michigan | Ann Arbor Michigan, United States, 48109Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48047National Clinical, LLC | Hamtramck Michigan, United States, 48212Gastroenterology Associates of Western Michigan, PLC | Wyoming Michigan, United States, 49519Mayo Clinic Health System - PPDS | Duluth Minnesota, United States, 55805Minnesota Gastroenterology PA | Saint Paul Minnesota, United States, 55114Digestive Health Center PA | Ocean Springs Mississippi, United States, 39564Washington University School of Medicine | St Louis Missouri, United States, 63110St Louis Center For Clinical Research | St Louis Missouri, United States, 63128Advanced Biomedical Research of America | Las Vegas Nevada, United States, 89123Encompass Care | North Las Vegas Nevada, United States, 89086New York Total Medical Care PC | Brooklyn New York, United States, 11215NYU Langone Long Island Clinical Research Associates | Great Neck New York, United States, 11021Weill Cornell Medical College | New York New York, United States, 10021Southtowns Gastroenterology, PLLC | Orchard Park New York, United States, 14127East Carolina Gastroenterology | Jacksonville North Carolina, United States, 28546Piedmont Healthcare | Statesville North Carolina, United States, 28625Gastro Health Research | Cincinnati Ohio, United States, 45219Consultants For Clinical Research Inc | Cincinnati Ohio, United States, 45249Consultants For Clinical Research Inc | Fairfield Ohio, United States, 45014Prestige Clinical Research | Franklin Ohio, United States, 45005Ohio Clinical Research Partners LLC | Mentor Ohio, United States, 44060Veteran's Research and Education Foundation - NAVREF - PPDS | Oklahoma City Oklahoma, United States, 73104Veterans Research Foundation of Pittsburgh - NAVREF - PPDS | Pittsburgh Pennsylvania, United States, 15240Penn State Hershey Medical Group | State College Pennsylvania, United States, 16803Digestive Disease Associates | Wyomissing Pennsylvania, United States, 19610Gastro One | Germantown Tennessee, United States, 38138Vanderbilt University Medical Center | Nashville Tennessee, United States, 37212Advanced Gastroenterology-Union City | Union City Tennessee, United States, 38237Northside Gastroenterology | Cypress Texas, United States, 77429Digestive Health Associates of Texas, P.A.dba DHAT Research Institute | Garland Texas, United States, 75044Precision Research Institute, LLC | Houston Texas, United States, 77039Biopharma Informatic Inc. | Houston Texas, United States, 77043Southwest Clinical Trials | Houston Texas, United States, 77074Aztec Medical Research | Houston Texas, United States, 77079Biopharma Informatic Research Center | Houston Texas, United States, 77084Southern Star Research Institute LLC | San Antonio Texas, United States, 78229DM Clinical Research - ERN - PPDS | Tomball Texas, United States, 77375Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS | Webster Texas, United States, 77598HP Clinical Research | Bountiful Utah, United States, 84010Mid Atlantic Health Specialists | Galax Virginia, United States, 24333Winchester Gastroenterology Associates | Winchester Virginia, United States, 22601-2872CHI Franciscan Digestive Care Associates | Tacoma Washington, United States, 98405Exemplar Research, Inc. - Elkins | Elkins West Virginia, United States, 26241West Virginia University Hospital | Morgantown West Virginia, United States, 26506Fundación Favaloro | Buenos Aires , Argentina, C1093AASHospital 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, Australia, 2139Liverpool Hospital | Liverpool New South Wales, Australia, 2170Royal Brisbane & Women's Hospital | Herston Queensland, Australia, 4029Mater Hospital Brisbane | South Brisbane Queensland, Australia, 4101Royal Adelaide Hospital | Adelaide South Australia, Australia, 5000The Alfred Hospital | Box Hill Victoria, Australia, 3128St Vincents Hospital Melbourne - PPDS | Melbourne Victoria, Australia, 3065A.ö. Krankenhaus der Barmherzigen Brüder | Sankt Veit an der Glan Carinthia, Austria, 9300LKH-Universitätsklinikum Klinikum Graz | Graz Styria, Austria, 8036Klinikum Klagenfurt Am Woerthersee | Klagenfurt , Austria, 9020Salzburger Landeskliniken | Salzburg , Austria, 5020Universitätsklinikum St. Pölten | Sankt Pölten , Austria, 3100Medizinische Universitat Wien (Medical University of Vienna) | Vienna , Austria, 1090Klinikum Wels-Grieskirchen GmbH | Wels , Austria, 4600UZ Gent | Ghent Oost-Vlaanderen, Belgium, 9000UZ Leuven- Gasthuisberg Campus | Leuven Vlaams Brabant, Belgium, 3000AZ Groeninge | Kortrijk West-Vlaanderen, Belgium, 8500CHU Mouscron | Mouscron , Belgium, 7700Clinical Center Banja Luka | Banja Luka , Bosnia and Herzegovina, 78000Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD | Sofia Sofia-Grad, Bulgaria, 1784University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski EAD | Pleven , Bulgaria, 5800Multiprofile Hospital for Active Treatment Eurohospital | Plovdiv , Bulgaria, 4004Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr.D.Gramatikov- Ruse- PPDS | Rousse , Bulgaria, 7002Medical Center-1-Sevlievo EOOD | Sevlievo , Bulgaria, 5400Medical Center Excelsior OOD - PPDS | Sofia , Bulgaria, 1000Second Multiprofile Hospital for Active Treatment Sofia | Sofia , Bulgaria, 1202Diagnostic and Consulting Center Aleksandrovska EOOD | Sofia , Bulgaria, 1431University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD | Sofia , Bulgaria, 1431University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD | Sofia , Bulgaria, 1527Medical Center Convex EOOD | Sofia , Bulgaria, 1680University Multiprofile Hospital for Active Treatment Sveta Anna | Sofia , Bulgaria, 1709Diagnostic Consultative Centre Mladost - M OOD | Varna , Bulgaria, 9000Percuro Clinical Research LTD | Victoria British Columbia, Canada, V8P 2P5Toronto Digestive Disease Associates Inc | Toronto Ontario, Canada, M3N 2V7Hospital Pablo Tobón Uribe | Medellín Antioquia, Colombia, 050034Servimed S.A.S | Bucaramanga Santander Department, Colombia, Fundación Valle Del Lili | Cali Valle del Cauca Department, Colombia, 760026IPS Centro Médico Julián Coronel S.A.S. - PPDS | Cali , Colombia, University Hospital Center Zagreb | Zagreb City of Zagreb, Croatia, 10000Opca Bolnica Karlovac | Karlovac Karlovacka Županija, Croatia, 47000Opca bolnica Bjelovar | Bjelovar , Croatia, 43000Clinical Hospital Centre Osijek | Osijek , Croatia, 31000University Hospital Centre Split | Split , Croatia, 21000General Hospital Virovitica | Virovitica , Croatia, 33000General County Hospital Vukovar and Croatian Veterans Hospital | Vukovar , Croatia, 32000General Hospital Zadar | Zadar , Croatia, 23 000Hepato-Gastroenterologie HK, s. r. o. | Hradec Králové Hradec Králové Region, Czechia, 500 12PreventaMed s.r.o. | Olomouc Olomouc Region, Czechia, 779 00Institut Klinicke A Experimentalni Mediciny | Prague , Czechia, 140 21ISCARE I.V.F. a.s. | Prague , Czechia, 170 00Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. | Ústí nad Labem , Czechia, 401 13Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice | Ústí nad Orlicí , Czechia, 562 18OÜ LV Venter | Pärnu Pärnumaa, Estonia, 80010East Viru Central Hospital | Kohta-Järve , Estonia, 31025West Tallinn Central Hospital | Tallinn , Estonia, 10617Universitätsklinikum Ulm | Ulm Baden-Wurttemberg, Germany, 89081Universitätsklinikum der RWTH Aachen | Aachen North Rhine-Westphalia, Germany, 52074Uniklinik Köln | Cologne North Rhine-Westphalia, Germany, 50937Gastro Campus Research GbR | Münster North Rhine-Westphalia, Germany, 48159Universitatsklinikum Schleswig-Holstein | Kiel Schleswig-Holstein, Germany, 24105Universitatsklinikum Jena | Jena Thuringia, Germany, 07747Charité - Universitätsmedizin Berlin | Berlin , Germany, 13353Gastroenterologische Facharztpraxis am Mexikoplatz | Berlin-Zehlendorf , Germany, 14163Sana Klinikum Biberach | Biberach an der Riss , Germany, 88400Universitätsklinikum Frankfurt | Frankfurt , Germany, 60596Asklepios Westklinikum Hamburg Ggmbh | Hamburg , Germany, 22559Klinikum rechts der Isa der Technischen Universitaet Muenchen | Munich , Germany, 81675Ippokrateio General Hospital of Athens | Athens Attica, Greece, 11527University General Hospital of Heraklion | Heraklion , Greece, 71110Iatriko Palaiou Falirou | Paliao Faliro , Greece, 17562University General Hospital of Patras | Pátrai , Greece, 26504Theageneio Anticancer Oncology Hospital of Thessaloniki | Thessaloniki , Greece, 54007Euromedica - PPDS | Thessaloniki , Greece, 54645Bekes Megyei Kozponti Korhaz | Békéscsaba , Hungary, 5600Magyar Honvédség Egészségügyi Központ | Budapest , Hungary, 1062Pannónia Magánorvosi Centrum Kft | Budapest , Hungary, 1136ENDOMEDIX Kft. | Budapest , Hungary, 1139Debreceni Egyetem Klinikai Kozpont | Debrecen , Hungary, 4032Bekes Megyei Kozponti Korhaz | Gyula , Hungary, 5700Mohacsi Korhaz | Mohács , Hungary, 7700Tolna Megyei Balassa János Kórház | Szekszárd , Hungary, 7100Csongrad Megyei Dr. Bugyi Istvan Korhaz | Szentes , Hungary, 6600Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár , Hungary, 8000Jávorszky Ödön Kórház | Vác , Hungary, 2600Csolnoky Ferenc Korhaz | Veszprém , Hungary, 8200St Vincent's University Hospital | Dublin , Ireland, Dublin 4Shaare Zedek Medical Center | Jerusalem , Israel, 91031Hadassah Medical Center - PPDS | Jerusalem , Israel, 91120Galilee Medical Center | Nahariya , Israel, 22100Nazareth EMMS Hospital | Nazareth , Israel, 16100Tel Aviv Sourasky Medical Center PPDS | Tel Aviv , Israel, 6423906Baruch Padeh Poriya Medical Center | Tiberias , Israel, 15208Ospedale Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo (FG) Apulia, Italy, 71013Azienda Ospedaliera Mater Domini Di Catanzaro | Catanzaro Calabria, Italy, 88100Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna Emilia-Romagna, Italy, 40138Azienda Ospedaliero Universitaria Di Modena Policlinico | Modena Emilia-Romagna, Italy, 41124Azienda Ospedaliera San Camillo Forlanini | Rome Lazio, Italy, 00152Azienda Ospedaliera Universitaria Careggi | Florence Tuscany, Italy, 50134IRCCS Ospedale Sacro Cuore Don Calabria | Negrar Veneto, Italy, 37024Azienda Ospedale Università Padova | Padova Veneto, Italy, 35128A.O.U. Maggiore della Carità | Novara , Italy, 28100Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia , Italy, 27100La Sapienza-Università di Roma-Policlinico Umberto I | Roma , Italy, 00161Fondazione Policlinico Universitario A Gemelli | Roma , Italy, 00168Istituto Clinico Humanitas | Rozzano (MI) , Italy, 20089Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino , Italy, 10126Azienda Ospedaliera Ordine Mauriziano di Torino | Torino , Italy, 10128Sapporo Tokushukai Hospital | Sapporo Hokkaidô, Japan, 004-0041Sapporo Medical University Hospital | Sapporo Hokkaidô, Japan, 060-8543Medical Corporation Aoyama Clinic | Kobe Hyôgo, Japan, 650-0015Hyogo College of Medicine | Nishinomiya-shi Hyôgo, Japan, 663-8501Sagamihara Kyodo Hospital | Sagamihara Kanagawa, Japan, 252-5188Dokkyo Medical University Saitama Medical Center | Koshigaya Saitama, Japan, 343-8555Nihonbashi Egawa Clinic | Chuo-Ku Tokyo, Japan, 103-0028Jikei University Hospital | Minato-ku Tokyo, Japan, 105-8471Kitasato University Kitasato Institute Hospital | Minato-ku Tokyo, Japan, 108-8642Ome Municipal General Hospital | Ōme Tokyo, Japan, 198-0042Tokatsu Tsujinaka Hospital | Abiko , Japan, 270-1166Kunimoto Hospital | Asahikawa , Japan, 070-0061Fukuoka University Chikushi Hospital | Chikushino-shi , Japan, 818-8502Hakodate Koseiin Hakodate Goryoukaku Hospital | Hakodate , Japan, 040-0001Yuai Memorial Hospital | Koga , Japan, 306-0232Kawabe Clinic | Koganei , Japan, 184-0003Hidaka Coloproctology Clinic | Kurume-shi , Japan, 839-0809Aizawa Hospital | Matsumoto-shi , Japan, 390-0814Aichi Medical University Hospital | Nagakute , Japan, 480-1195Nishinomiya Municipal Central Hospital | Nishinomiya , Japan, 663-8014Onomichi General Hospital | Onomichi , Japan, Chiinkai Dojima General & Gastroenterology Clinic | Osaka , Japan, 530-0003Kinshukai Infusion Clinic | Osaka , Japan, 530-0011Shiga University of Medical Science Hospital | Ōtsu , Japan, 520-2192Bellland General Hospital | Sakai , Japan, 599-8247Toho University Sakura Medical Center | Sakura , Japan, 285-8741Sapporo Higashi Tokushukai Hospital | Sapporo , Japan, 065-0033Tohoku Rosai Hospital | Sendai , Japan, 981-8563Dokkyo Medical University Hospital | Shimotsuga-gun , Japan, 321-0293Medical Corporation Shoyu-kai Fujita Gastroenterology Hospital | Takatsuki , Japan, 569-0086Koukokukai Ebisu Clinic | Tokyo , Japan, 150-0013Colo-Proctology Center Matsushima Clinic | Yokohama , Japan, 220-0045Shinbeppu Hospital | Beppu Ôita, Japan, 874-8538Ishida Clinic of IBD and Gastroenterology | Ōita Ôita, Japan, 870-0823Yodogawa Christian Hospital | Osaka Ôsaka, Japan, 533-0024Al Zahraa University Hospital | Beirut , Lebanon, Rafik Hariri University Hospital | Beirut , Lebanon, Hammoud Hospital University Medical Center | Saida , Lebanon, Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas , Lithuania, LT-50009Vilnius University Hospital Santaros Klinikos | Vilnius , Lithuania, LT- 08661Vilnius City Clinical Hospital | Vilnius , Lithuania, LT-10207Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. | Zapopan Jalisco, Mexico, 45030Centro de Investigacion Clinica Acelerada, S.C. | Tepeyac Insurgentes Mexico City, Mexico, 07020Clinica de Higado y Gastroenterologia Integral, S.C. | Cuernavaca Morelos, Mexico, 62170JM Research S.C | Cuernavaca Morelos, Mexico, 62290Accelerium, S. de R.L. de C.V. - PPDS | Monterrey Nuevo León, Mexico, 64000Unidad de Atencion Medica e Investigacion en Salud | Mérida Yucatán, Mexico, 97000Centro de Investigación Médica Aguascalientes | Aguascalientes , Mexico, 20116Phylasis Clinicas Research S. de R.L. de C.V. | Cuautitlán Izcalli , Mexico, 54769Instituto de Investigaciones Aplicadas a la Neurociencia A.C. | Durango , Mexico, 34000Accelerium, S. de R.L. de C.V. | Monterrey , Mexico, 64000Clinical Research Institute | Tlalnepantla , Mexico, 54055ETZ-Elisabeth | Tilburg North Brabant, Netherlands, 5022 GCNWZ, location Alkmaar | Alkmaar North Holland, Netherlands, 1815 JDLeids Universitair Medisch Centrum | Leiden South Holland, Netherlands, 2333 ZAVU Medisch Centrum | Amsterdam , Netherlands, 1081 HVAmsterdam UMC - Meibergdreef 9 | Amsterdam , Netherlands, 1105 AZAuckland City Hospital | Grafton Auckland, New Zealand, 1023Dunedin Hospital | Dunedin South Island, New Zealand, 9016Wellington Hospital | Newtown Wellington Region, New Zealand, 6021Waikato Hospital | Hamilton , New Zealand, 3240Vitamed Galaj i Cichomski sp.j. | Bydgoszcz Kuyavian-Pomeranian Voivodeship, Poland, 85-079Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. | Włocławek Kuyavian-Pomeranian Voivodeship, Poland, 87-800Krakowskie Centrum Medyczne | Krakow Lesser Poland Voivodeship, Poland, 31-501Melita Medical | Wroclaw Lower Silesian Voivodeship, Poland, 50-449Lexmedica | Wroclaw Lower Silesian Voivodeship, Poland, 53-114Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny | Lódz Lódzkie, Poland, 90-302Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow | Lódz Lódzkie, Poland, 90-647Instytut Centrum Zdrowia Matki Polki | Lódz Lódzkie, Poland, 93-338BioVirtus Centrum Medyczne | Józefów Masovian Voivodeship, Poland, 05-410Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warsaw Masovian Voivodeship, Poland, 02-781Niepubliczny Zakład Opieki Zdrowotnej VIVAMED | Warsaw Masovian Voivodeship, Poland, 03-580Miedzyleski Szpital Specjalistyczny w Warszawie | Warsaw Masovian Voivodeship, Poland, 04-749Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok Podlaskie Voivodeship, Poland, 15-276Endoskopia Sp. z o.o. | Sopot Pomeranian Voivodeship, Poland, 81-756Szpital Zakonu Bonifratrow pw. Aniolow Strozow w Katowicach | Katowice Silesian Voivodeship, Poland, 40-211Twoja Przychodnia SCM | Szczecin West Pomeranian Voivodeship, Poland, 71-434Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy | Bydgoszcz , Poland, 85-168Centrum Medyczne Bydgoszcz- PRATIA - PPDS | Bydgoszcz , Poland, 85-796Centrum Medyczne Czestochowa - PRATIA - PPDS | Częstochowa , Poland, 42-200Centrum Medyczne Gdynia - PRATIA - PPDS | Gdynia , Poland, 81-338NZOZ All Medicus | Katowice , Poland, 40-659Centrum Medyczne A-Z Clinic Mateusz Sidor, Piotr Puc-Lekarze Spolka Partnerska | Krakow , Poland, 31-315Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. | Ksawerów , Poland, 95-054Med Gastr Sp.z.o.o Sp.k | Lodz , Poland, 91-034Twoja Przychodnia NCM | Nowa Sól , Poland, 67-100Centrum Innowacyjnych Terapii | Piaseczno , Poland, 05-500Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa | Poznan , Poland, Korczowski Bartosz, Gabinet Lekarski | Rzeszów , Poland, 35-302Sonomed Sp. z o.o. | Szczecin , Poland, 70-361Sonomed Sp. z o.o. | Szczecin , Poland, 71-685H-T. Centrum Medyczne Endoterapia | Tychy , Poland, 43-100Centrum Zdrowia MDM | Warsaw , Poland, 00-635Centrum Medyczne Warszawa - PRATIA - PPDS | Warsaw , Poland, 01-868Centralny Szpital Kliniczny MSW | Warsaw , Poland, 02-507Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II | Zamość , Poland, 22-400Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii | Gmina Końskie Świętokrzyskie Voivodeship, Poland, 26-200Hospital de Braga | Braga , Portugal, 4710-243Centro Hospitalar do Algarve - Hospital de Portimao | Faro , Portugal, 8000-385Hospital Senhora da Oliveira - Guimaraes, E.P.E | Guimarães , Portugal, 4835-044Hospital da Luz | Lisbon , Portugal, 1500-650Hospital de São Bernardo | Setúbal , Portugal, 2910-446Dr.Carol Davila Emergency University Central Military Hospital | Bucharest , Romania, 010825Sana Monitoring SRL | Bucharest , Romania, 011025Colentina Clinical Hospital | Bucharest , Romania, 020125Prof. Dr. Matei Bals Institute of Infectious Diseases | Bucharest , Romania, 021105Fundeni Clinical Institute | Bucharest , Romania, 022328SC Centrul Medical MEDICUM S.R.L. | Bucharest , Romania, 031864Emergency University Hospital | Bucharest , Romania, 050098Cluj-Napoca Emergency Clinical County Hospital | Cluj-Napoca , Romania, 400006Affidea Romania SRL | Constanța , Romania, RO-900591Gastromedica SRL | Iași , Romania, 700506Dr. Tirnaveanu Amelita Private Practice | Oradea , Romania, 410066Dr. Goldis Gastroenterology Center SRL | Timișoara , Romania, 300002St. Elizabeth Municipal Clinical Hospital | Saint Petersburg Sankt-Peterburg, Russia, 195257Kazan State Medical University | Kazan' , Russia, 420097Moscow Clinical Scientific Center | Moscow , Russia, 111123Moscow Regional Research Clinical Institute Na Mfvladimirskiy | Moscow , Russia, 129110Nizhegorodskaya Regional Clinical Hospital n.a. Semashko | Nizhny Novgorod , Russia, 603126Research Institute of Physiology and Basic Medicine | Novosibirsk , Russia, 630117Rostov State Medical University | Rostov-on-Don , Russia, 344022Rostov State Medical University | Rostov-on-Don , Russia, 344091First St. Petersburg State Medical University n.a. I.P Pavlov | Saint Petersburg , Russia, 197022Union Clinic, LLC | Saint Petersburg , Russia, 197110Russian Medical Military Academy n.a. S.M. Kirov | Saint Petersburg , Russia, Medical University Reaviz | Samara , Russia, 443011Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city | Samara , Russia, 443029Medical Company Hepatolog, LLC | Samara , Russia, 443063SHI Regional Clinical Hospital | Saratov , Russia, 410012Smolensk Regional Clinical Hospital | Smoensk , Russia, 214018Stavropol State Medical University | Stavropol , Russia, 355017Regional Consulting and Diagnostics Centre | Tyumen , Russia, 625026Clinical Hospital Center Bezanijska Kosa | Belgrade , Serbia, 11080University Clinical Center Nis | Niš , Serbia, 18000General Hospital Vrsac | Vršac , Serbia, 26300Clinical Hospital Center Zemun | Zemun , Serbia, University Clinical Center Kragujevac | Kragujevac Šumadijski Okrug, Serbia, 34000Univerzitna nemocnica Bratislava | Bratislava , Slovakia, 851 07KM Management, spol. s r.o. | Nitra , Slovakia, 949 01Gastro LM, s.r.o. | Prešov , Slovakia, 080 01CLINRESCO, ARWYP Medical Suites | Johannesburg Gauteng, South Africa, 1619Dr. J Breedt | Pretoria Gauteng, South Africa, 0002Dr JP Wright | Claremont Western Cape, South Africa, 7708Kyungpook National University Hospital | Daegu Daegu Gwang'yeogsi, South Korea, 41944Yonsei University Wonju Severance Christian Hospital | Wŏnju Gang'weondo, South Korea, 26426CHA Bundang Medical Center, CHA University | Seongnam Gyeonggido, South Korea, 13496The Catholic University of Korea, St. Vincent's Hospital | Suwon Gyeonggido, South Korea, 16247Inje University Haeundae Paik Hospital | Busan , South Korea, 48108Pusan National University Hospital | Busan , South Korea, 49241Yeungnam University Hospital | Daegu , South Korea, 42415Gachon University Gil Medical Center | Incheon , South Korea, 21565Kyung Hee University Hospital | Seoul , South Korea, 02447Seoul National University Hospital | Seoul , South Korea, 03080Kangbuk Samsung Hospital | Seoul , South Korea, 03181Severance Hospital Yonsei University Health System - PPDS | Seoul , South Korea, 03722Asan Medical Center - PPDS | Seoul , South Korea, 05505Samsung Medical Center PPDS | Seoul , South Korea, 06351C.H. Regional Reina Sofia - PPDS | Córdoba Córdoba, Spain, 14004Hospital Universitario de Fuenlabrada | Fuenlabrada Madrid, Spain, 28942Hospital General Universitario Gregorio Maranon | Madrid Madrid, Communidad Delaware, Spain, 28007CHUVI - H.U. Alvaro Cunqueiro | Vigo Pontevedra, Spain, 36312Centro Medico Teknon - Grupo Quironsalud | Barcelona , Spain, 08022Hospital Universitario Juan Ramon Jimenez | Huelva , Spain, 21005Hospital Universitario de La Princesa | Madrid , Spain, 28006Hospital Universitario Fundacion Jimenez Diaz | Madrid , Spain, 28040Hospital Universitario La Paz - PPDS | Madrid , Spain, 28046Hospital Universitario Virgen del Rocio - PPDS | Seville , Spain, 41013Hospital Universitari i Politecnic La Fe de Valencia | Valencia , Spain, 46026Universität Zürich | Zurich Zürich (de), Switzerland, 8091Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul , Turkey (Türkiye), 34098Mersin University Medical Faculty | Mersin , Turkey (Türkiye), 33169Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital" | Chernivtsi Chernivtsi Oblast, Ukraine, 58001Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council | Kharkiv Kharkivs’ka Oblast’, Ukraine, 61037Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VR | Vinnytsia Vinnytsia Oblast, Ukraine, 21018Municipal Non-profit Enterprise City Emergency Care Hospital of Zaporizhzhia Regional Council | Zaporizhzhia Zaporizhzhia Oblast, Ukraine, 69005ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council | Dnipro , Ukraine, 49005LLC Medical Center Family Medicine Clinic | Dnipro , Ukraine, 49038State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine" | Dnipro , Ukraine, 49074Clinic of SI National Institute of Therapy n.a. L.T. Mala of NAMS of Ukraine | Kharkiv , Ukraine, 61039Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv , Ukraine, 61058MNPE of Kharkiv Regional Council Regional Clinical Specialised Dispensary of Radiation Protection | Kharkiv , Ukraine, 61166Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh | Kherson , Ukraine, 73000Municipal Enterprise Kryvyi Rih City Clinical Hospital #2 of Kryvyi Rih City Council | Kryvyi Rih , Ukraine, 50056Medical Center of LLC Medical Clinic Blagomed | Kyiv , Ukraine, 01023Kyiv City Clinical Hospital #18 | Kyiv , Ukraine, 01030Treatment and Diagnostic Center "Healthy and Happy" of LLC "Healthy and Happy" | Kyiv , Ukraine, 01033Medical Center OK!Clinic+LLC International Institute of Clinical Research | Kyiv , Ukraine, 02091Medical Center of LLC Medical Center Dopomoga-Plus | Kyiv , Ukraine, 02132Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital | Kyiv , Ukraine, 04073Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital | Kyiv , Ukraine, 04107Lviv Railway Clinical Hospital of branch Health Center of Joint Stock Co. Ukrainian Railway | Lviv , Ukraine, 79007MNE Lviv Territorial Med Ass-n Multidisciplinary Clinical Hospital for Intensive Care and Ambulance | Lviv , Ukraine, 79059Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council | Odesa , Ukraine, 65025MNPE Central City Clinical Hospital of Uzhhorod City Council | Uzhhorod , Ukraine, 88000Medical Clinical Research Center of Medical Center LLC Health Clinic | Vinnytsia , Ukraine, 21009Communal Nonprofit Enterprise Vinnytsia Regional Clinical Hospital named after N.I. Pirogov VRC | Vinnytsia , Ukraine, 21018Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1 | Vinnytsia , Ukraine, 21029MNPE City Hospital No. 6 of Zaporizhzhia City Council | Zaporizhzhia , Ukraine, 69035Fairfield General Hospital - PPDS | Lancashire Bury, United Kingdom, BL9 7TDWhipps Cross University Hospital | London London, City of, United Kingdom, E11 1NRNorth Tyneside General Hospital | North Shields Northumberland, United Kingdom, NE29 8NHRoyal Shrewsbury Hospital | Shrewsbury Shropshire, United Kingdom, SY3 8XQAberdeen Royal Infirmary - PPDS | Aberdeen , United Kingdom, AB25 2ZNWestern General Hospital Edinburgh - PPDS | Edinburh , United Kingdom, EH4 2XURoyal Gwent Hospital - PPDS | Newport , United Kingdom, NP20 2UBNew Cross Hospital | Wolverhampton , United Kingdom, WV10 0QP
Investigators
Study Director: Study Director, Shire
Study Documents (Full Text)
Documents provided by Shire: Study Protocol  September 20, 2020Documents provided by Shire: Statistical Analysis Plan  September 5, 2022