The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
NCT ID: NCT04985968
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
171 participants
INTERVENTIONAL
2021-11-24
2023-12-20
Brief Summary
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Detailed Description
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In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cobitolimod 250 mg
Dose of 250 mg cobitolimod
2 treatments during induction study and subsequently every third week
Cobitolimod 250 mg
Rectal administration
Cobitolimod 500 mg
Dose of 500 mg cobitolimod
2 treatments during induction study and subsequently every third week
Cobitolimod 500 mg
Rectal administration
Placebo
Dose of Placebo
2 treatments during induction study and subsequently every third week
Placebo
Rectal administration
Interventions
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Cobitolimod 250 mg
Rectal administration
Cobitolimod 500 mg
Rectal administration
Placebo
Rectal administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of UC.
* Moderate to severe active left-sided UC assessed by central reading.
* Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
* Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
* Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.
* Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.
Exclusion Criteria
* Acute fulminant UC and/or signs of systemic toxicity.
* UC limited to the rectum or extending beyond the splenic flexure.
* Have failed treatment with more than three advanced therapies of two different therapeutic classes.
* Have had surgery for treatment of UC.
* History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
* History or presence of any clinically significant disorder.
* Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
* Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
* Long-term treatment (\>14 days) with antibiotics or NSAIDs .
* Serious known active infection including history of latent or active tuberculosis.
* Gastrointestinal infections including positive Clostridium difficile stool assay.
* Females who are lactating or have a positive serum pregnancy test.
* Women of childbearing potential not using highly effective contraceptive methods.
* Concurrent participation in another clinical study.
* Previous exposure to cobitolimod.
* Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.
18 Years
ALL
No
Sponsors
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InDex Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Raja Atreya, Professor
Role: PRINCIPAL_INVESTIGATOR
Friedrich-Alexander University Erlangen-Nuremberg
Locations
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Accout Center s.r.o.
Šahy, , Slovakia
Inje University Haeundae Paik Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
CLINIQ s.r.o.
Bratislava, , Slovakia
Amicis Research Center
Granada Hills, California, United States
Allameh Medical Corporation
Mission Viejo, California, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, United States
Valiance Clinical Research
Tarzana, California, United States
RecioMed Clinical Research Network, Inc.
Boynton Beach, Florida, United States
MB & V Medical Research
Doral, Florida, United States
A+ Research, Inc.
Miami, Florida, United States
SouthCoast Research Center, Inc
Miami, Florida, United States
I.V.A.M. Clinical & Investigational Center LLC
Miami, Florida, United States
D&H National Research Centers, Inc.
Miami, Florida, United States
Medical Professionals Clinical Research Center
Miami, Florida, United States
Gastroenterology Group Of Naples
Naples, Florida, United States
Alliance Clinical Research - Gastroenterology
Tampa, Florida, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Clinical Research Institute of Michigan
Troy, Michigan, United States
Lenox Hill Hospital
New York, New York, United States
Carolina Digestive Health Associates, PA
Charlotte, North Carolina, United States
Carolina Research
Greenville, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Dayton Gastroenterology
Beavercreek, Ohio, United States
Digestive Health Associates of Texas, PA
Carrollton, Texas, United States
Clinical Research Solution: Digestive Health Associates
Houston, Texas, United States
Baylor College of Medicine - Gastroeneterology
Houston, Texas, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States
Wisconsin Center For Advanced Research
Milwaukee, Wisconsin, United States
Monash Health
Clayton, , Australia
St Vincent's Hospital Melbourne
Fitzroy, , Australia
The Alfred Hospital
Melbourne, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Mater Health Services
South Brisbane, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
MedUn Innsbruck
Innsbruck, , Austria
LKH Klagenfurt
Klagenfurt, , Austria
Universitätsklinikum Salzburg
Salzburg, , Austria
Akh Wien
Vienna, , Austria
UZ Antwerpen
Antwerp, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
Erasme University Hospital
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Groeninge - Campus Kennedylaan
Kortrijk, , Belgium
AZ Delta
Roeselare, , Belgium
University Clinical Centre of the Republic of Srpska - Gastroenterology
Banja Luka, , Bosnia and Herzegovina
The University Hospital Foca
Foča, , Bosnia and Herzegovina
Clinical Center University of Sarajevo - Gastroenterology
Sarajevo, , Bosnia and Herzegovina
General Hospital "Prim.dr.Abdulah Nakas"
Sarajevo, , Bosnia and Herzegovina
Polyclinic Dr. Al-Tawil
Sarajevo, , Bosnia and Herzegovina
Opca Bolnica Tesanj
Tešanj, , Bosnia and Herzegovina
Plava Medical Group
Tuzla, , Bosnia and Herzegovina
Cantonal Hospital Zenica
Zenica, , Bosnia and Herzegovina
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, , Brazil
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
Porto Alegre, , Brazil
Ufrj - Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, , Brazil
Praxis Pesquisa Medica
Santo André, , Brazil
CEMEC - Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, , Brazil
Kaiser Clinica
São José do Rio Preto, , Brazil
MUMC - Hamilton Health Sciences
Hamilton, , Canada
Installation Hospital Maisonneuve-Rosemont
Montreal, , Canada
Royal University Hospital
Saskatoon, , Canada
Opca bolnica Bjelovar
Bjelovar, , Croatia
Clinical Hospital Osijek
Osijek, , Croatia
Opca bolnica Pula
Pula, , Croatia
Zadar General Hospital
Zadar, , Croatia
Poliklinika Solmed
Zagreb, , Croatia
University Hospital Centre Zagreb
Zagreb, , Croatia
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Herlev Hospital
Herlev, , Denmark
Hillerod Hospital
Hillerød, , Denmark
Lillebælt Hospital Vejle
Vejle, , Denmark
CHRU de Lille - Hôpital Claude Huriez
Lille, , France
CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie
Montpellier, , France
CHU de Nancy Brabois
Nancy, , France
CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie
Nice, , France
Hopital Bichat - Gastroenterology
Paris, , France
Hopital Saint Antoine
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie
Saint-Etienne, , France
CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog
Salouël, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
Toulouse, , France
JSC " Evex Hospitals"
Batumi, , Georgia
LTD Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, , Georgia
Universitätsklinikum Augsburg
Augsburg, , Germany
Charité - Universitätsmedizin Berlin KöR
Berlin, , Germany
University Hospital Cologne AöR
Cologne, , Germany
MVZ Sanaklinikum Duisburg
Duisburg, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, , Germany
Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I
Frankfurt am Main, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Uniklinik Halle (Saale)
Halle, , Germany
Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt
Heidelberg, , Germany
University Hospital Schleswig-Holstein
Kiel, , Germany
Universitätsmedizin Mannheim
Mannheim, , Germany
Medius Klinik Nürtingen
Nürtingen, , Germany
Universitätsklinikum Rostock
Rostock, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Internistische Praxis Weyhe
Weyhe, , Germany
Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.
Budapest, , Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, , Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
Budapest, , Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, , Hungary
SzTE Szt-Gy A Orvostud Kar Bel Klin
Szeged, , Hungary
The Barzilai Medical Center
Ashkelon, , Israel
The Edith Wolfson Medical Center
Holon, , Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-
Jerusalem, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Galilee Medical Center (Western Galilee Hospital)
Nahariya, , Israel
Kaplan Medical Center
Rehovot, , Israel
ASST Papa Giovanni XXIII - Cardiologia - Bergamo
Bergamo, , Italy
AO Brotzu
Cagliari, , Italy
Universita degli Studi di Firenze - Azienda Ospedaliero - Un
Florence, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliera San Gerardo
Monza, , Italy
AOU di Padova
Padua, , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P
Roma, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Policlinico Universitario Campus Biomedico
Rome, , Italy
A.O. Ordine Mauriziano Di Torino
Torino, , Italy
AOU S. Maria della Misericordia
Udine, , Italy
Universita degli Studi dell'Insubria - Ospedale di Circolo e
Varese, , Italy
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, , Lithuania
Klaipeda Seamen's Hospital
Klaipėda, , Lithuania
Republic Klaipeda Hospital
Klaipėda, , Lithuania
ENDOMED s.r.o.
Košice, , Slovakia
Panevezio ligonine
Panevezys, , Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos
Vilnius, , Lithuania
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, , Mexico
Clinicos Asociados Bocm, S.C.
Mexico City, , Mexico
Medical Care and Research S. A. de C. V
Mérida, , Mexico
Centro Regiomontano de Estudios Clinicos Roma SC
Monterrey, , Mexico
Clinical Research Institute S.C.
Tlalnepantla, , Mexico
Radboud University Medical Center
Nijmegen, , Netherlands
Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR
Ålesund, , Norway
Akershus Universitetssykehus
Lørenskog, , Norway
Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8
Tromsø, , Norway
Vestfold Hjertesenter As
Tønsberg, , Norway
MPS - MED sp. z o.o.
Grudziądz, , Poland
MZ Badania Slowik Zymla Spolka jawna
Knurów, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
Centrum Medyczne PROMED
Krakow, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi
Lodz, , Poland
Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
Malbork, , Poland
Twoja Przychodnia - Opolskie Centrum Medyczne
Opole, , Poland
Medicome Sp. z o.o.
Oświęcim, , Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, , Poland
ETG Skierniewice
Skierniewice, , Poland
KO-MED Centra Kliniczne Staszow
Staszów, , Poland
Twoja Przychodnia - SCM
Szczecin, , Poland
GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie
Torun, , Poland
Bodyclinic sp. z o.o. sp.k.
Warsaw, , Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
Warsaw, , Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
Warsaw, , Poland
PlanetMed
Wroclaw, , Poland
ETG Zamosc
Zamość, , Poland
Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)
Amadora, , Portugal
Hospital de Braga
Braga, , Portugal
GASTROMEDIC, s.r.o.
Nové Zámky, , Slovakia
Hospital Beatriz Angelo (HBA)
Loures, , Portugal
Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião
Santa Maria da Feira, , Portugal
Sana Monitoring
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi
Iași, , Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, , Romania
Cabinet Particular Policlinic Algomed
Timișoara, , Romania
Clinic Center of Serbia
Belgrade, , Serbia
Clinical Hospital Center "Dr. Dragisa Misovic"
Belgrade, , Serbia
Euromedik Hospital
Belgrade, , Serbia
Zvezdara University Medical Center
Belgrade, , Serbia
Clinical Center Kragujevac - Center for Gastroenterohepatology
Kragujevac, , Serbia
General Hospital Dr Djordje Joanovic
Zrenjanin, , Serbia
General hospital Zrenjanin
Zrenjanin, , Serbia
FNsP F.D.R. Banska Bystrica
Banská Bystrica, , Slovakia
Hanyang University Guri Hospital
Guri-si, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kyung Hee University Hospital - Internal Medicine
Soeul, , South Korea
Kyung Hee University Hospital
Soeul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, , South Korea
Örebro Univ. Hospital
Örebro, , Sweden
Karolinska Universitetssjukhuset - Gastroenterology
Stockholm, , Sweden
Uppsala University Hospital, Akademiska
Uppsala, , Sweden
Hacettepe University Medical Faculty - Hematology
Ankara, , Turkey (Türkiye)
Istanbul University Medical Faculty
Istanbul, , Turkey (Türkiye)
Mersin Universtiy Medical Faculty
Mersin, , Turkey (Türkiye)
Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology
Bury, , United Kingdom
Accellacare Warwickshire Quality Research Site
Coventry, , United Kingdom
County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital
Darlington, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
North West London Hospitals NHS Trust
Harrow, , United Kingdom
Central Middlesex Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Accellacare North London
Northwood, , United Kingdom
Accellacare Limited/Accellacare of South London
Orpington, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Countries
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Other Identifiers
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CSUC-01/21
Identifier Type: -
Identifier Source: org_study_id