The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (CONCLUDE)
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Colitis, Ulcerative, Gastrointestinal Disease, Inflammatory Bowel Diseases, Glucocorticosteroids, Anti-Inflammatory Agents, Therapeutic uses, Cobitolimod, Toll like receptor 9 agonist, TLR9 agonist, Kappaproct, IDX0150, DIMS0150
Eligibility Criteria
Inclusion Criteria Induction:
- Male or female ≥ 18 years of age.
- 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.
Exclusion Criteria Induction:
- Suspicion of differential diagnosis.
- 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.
Inclusion Criteria Maintenance:
- 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 Maintenance:
- Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.
Sites / Locations
- Amicis Research CenterRecruiting
- Allameh Medical CorporationRecruiting
- Prospective Research Innovations Inc.Recruiting
- Valiance Clinical Research
- RecioMed Clinical Research Network, Inc.Recruiting
- MB & V Medical ResearchRecruiting
- A+ Research, Inc.Recruiting
- SouthCoast Research Center, IncRecruiting
- I.V.A.M. Clinical & Investigational Center LLCRecruiting
- D&H National Research Centers, Inc.
- Medical Professionals Clinical Research CenterRecruiting
- Gastroenterology Group Of NaplesRecruiting
- Alliance Clinical Research - GastroenterologyRecruiting
- Cotton O'Neil Clinical Research CenterRecruiting
- Clinical Research Institute of MichiganRecruiting
- Lenox Hill HospitalRecruiting
- Carolina Digestive Health Associates, PARecruiting
- Carolina ResearchRecruiting
- Peters Medical ResearchRecruiting
- Dayton GastroenterologyRecruiting
- Digestive Health Associates of Texas, PARecruiting
- Clinical Research Solution: Digestive Health AssociatesRecruiting
- Baylor College of Medicine - Gastroeneterology
- Gastroenterology Associates of Northern VirginiaRecruiting
- Wisconsin Center For Advanced ResearchRecruiting
- Monash HealthRecruiting
- St Vincent's Hospital MelbourneRecruiting
- The Alfred HospitalRecruiting
- Royal Melbourne HospitalRecruiting
- Mater Health ServicesRecruiting
- Princess Alexandra HospitalRecruiting
- MedUn InnsbruckRecruiting
- LKH KlagenfurtRecruiting
- Universitätsklinikum SalzburgRecruiting
- Akh WienRecruiting
- UZ AntwerpenRecruiting
- Imelda ZiekenhuisRecruiting
- Erasme University Hospital
- Universitair Ziekenhuis GentRecruiting
- AZ Groeninge - Campus KennedylaanRecruiting
- AZ DeltaRecruiting
- University Clinical Centre of the Republic of Srpska - GastroenterologyRecruiting
- The University Hospital FocaRecruiting
- Clinical Center University of Sarajevo - GastroenterologyRecruiting
- General Hospital "Prim.dr.Abdulah Nakas"
- Polyclinic Dr. Al-TawilRecruiting
- Opca Bolnica TesanjRecruiting
- Plava Medical GroupRecruiting
- Cantonal Hospital ZenicaRecruiting
- Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
- Hospital de Clinicas de Porto Alegre - Centro de Pesquisa ClinicaRecruiting
- Ufrj - Hospital Universitario Clementino Fraga FilhoRecruiting
- Praxis Pesquisa MedicaRecruiting
- Kaiser ClinicaRecruiting
- CEMEC - Centro Multidisciplinar de Estudos ClinicosRecruiting
- MUMC - Hamilton Health Sciences
- Installation Hospital Maisonneuve-Rosemont
- Royal University Hospital
- Opca bolnica BjelovarRecruiting
- Clinical Hospital OsijekRecruiting
- Opca bolnica PulaRecruiting
- Zadar General HospitalRecruiting
- Poliklinika SolmedRecruiting
- University Hospital Centre ZagrebRecruiting
- Aalborg University Hospital
- Aarhus University Hospital
- Herlev Hospital
- Hillerod Hospital
- Lillebælt Hospital Vejle
- CHRU de Lille - Hôpital Claude HuriezRecruiting
- CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologieRecruiting
- CHU de Nancy BraboisRecruiting
- CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, HépatologieRecruiting
- Hopital Saint AntoineRecruiting
- Hopital Bichat - GastroenterologyRecruiting
- Centre Hospitalier Lyon SudRecruiting
- Centre Hospitalier Universitaire de PoitiersRecruiting
- CHU de Saint Etienne, Hôpital Nord - Service de GastroentérologieRecruiting
- CHU Amiens - Hopital Sud - Service Hepato-GastroenterologRecruiting
- Centre Hospitalier Universitaire de Toulouse - Hopital RangueilRecruiting
- JSC " Evex Hospitals"Recruiting
- LTD Israel-Georgian Medical Research Clinic HelsicoreRecruiting
- Universitätsklinikum Augsburg
- Charité - Universitätsmedizin Berlin KöRRecruiting
- University Hospital Cologne AöRRecruiting
- MVZ Sanaklinikum Duisburg
- Universitätsklinikum ErlangenRecruiting
- Agaplesion Markus KrankenhausRecruiting
- Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I
- Universitätsklinikum FreiburgRecruiting
- Uniklinik Halle (Saale)Recruiting
- Gastroenterology Outpatient Clinic Prof. Dr. med. EhehaltRecruiting
- University Hospital Schleswig-HolsteinRecruiting
- Universitätsmedizin MannheimRecruiting
- Medius Klinik NürtingenRecruiting
- Universitätsklinikum RostockRecruiting
- Universitätsklinikum UlmRecruiting
- Internistische Praxis WeyheRecruiting
- Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.Recruiting
- Pannónia Magánorvosi Centrum KftRecruiting
- Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai KlinikaRecruiting
- Semmelweis Egyetem Altalanos Orvostudomanyi Kar
- SzTE Szt-Gy A Orvostud Kar Bel KlinRecruiting
- The Barzilai Medical CenterRecruiting
- The Edith Wolfson Medical CenterRecruiting
- Hadassah Medical Organization, Hadassah Medical Center, Ein-Recruiting
- Shaare Zedek Medical CenterRecruiting
- Galilee Medical Center (Western Galilee Hospital)
- Kaplan Medical Center
- ASST Papa Giovanni XXIII - Cardiologia - Bergamo
- AO Brotzu
- Universita degli Studi di Firenze - Azienda Ospedaliero - Un
- IRCCS Ospedale San Raffaele
- Azienda Ospedaliera San Gerardo
- AOU di Padova
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P
- Policlinico Universitario Agostino GemelliRecruiting
- Policlinico Universitario Campus BiomedicoRecruiting
- A.O. Ordine Mauriziano Di Torino
- AOU S. Maria della MisericordiaRecruiting
- Universita degli Studi dell'Insubria - Ospedale di Circolo e
- Inje University Haeundae Paik HospitalRecruiting
- Kyungpook National University HospitalRecruiting
- Hanyang University Guri HospitalRecruiting
- Kyung Hee University Hospital
- Seoul National University Bundang HospitalRecruiting
- Seoul National University HospitalRecruiting
- Kyung Hee University Hospital - Internal MedicineRecruiting
- Kyung Hee University HospitalRecruiting
- The Catholic University of Korea, St. Vincent's HospitalRecruiting
- Yonsei University, Wonju Severance Christian HospitalRecruiting
- Hospital of Lithuanian University of Health Sciences Kauno KlinikosRecruiting
- Klaipeda Seamen's HospitalRecruiting
- Republic Klaipeda HospitalRecruiting
- Panevezio ligonineRecruiting
- Vilniaus Universiteto ligonines Santariskiu KlinikosRecruiting
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C.Recruiting
- Medical Care and Research S. A. de C. VRecruiting
- Clinicos Asociados Bocm, S.C.Recruiting
- Centro Regiomontano de Estudios Clinicos Roma SCRecruiting
- Clinical Research Institute S.C.Recruiting
- Radboud University Medical CenterRecruiting
- Akershus UniversitetssykehusRecruiting
- Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8Recruiting
- Vestfold Hjertesenter As
- Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR
- MPS - MED sp. z o.o.Recruiting
- MZ Badania Slowik Zymla Spolka jawnaRecruiting
- Centrum Medyczne PROMEDRecruiting
- Krakowskie Centrum Medyczne Sp. z o.o.Recruiting
- Centrum Medyczne PlejadyRecruiting
- Szpital Zakonu Bonifratrow Sw. Jana Bozego w LodziRecruiting
- Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.Recruiting
- Twoja Przychodnia - Opolskie Centrum MedyczneRecruiting
- Medicome Sp. z o.o.Recruiting
- Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w PoznaniuRecruiting
- ETG SkierniewiceRecruiting
- KO-MED Centra Kliniczne Staszow
- Twoja Przychodnia - SCMRecruiting
- GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety LekarskieRecruiting
- Centrum Zdrowia Matki, Dziecka i Mlodziezy
- Bodyclinic sp. z o.o. sp.k.Recruiting
- Centralny Szpital Kliniczny MSWiA w WarszawieRecruiting
- PlanetMed
- ETG ZamoscRecruiting
- Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)Recruiting
- Hospital de BragaRecruiting
- Hospital Beatriz Angelo (HBA)Recruiting
- Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São SebastiãoRecruiting
- Spitalul Clinic Colentina
- Sana MonitoringRecruiting
- Spitalul Clinic Judetean de Urgenta Cluj-NapocaRecruiting
- Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi
- Cabinet Particular Policlinic Algomed
- Spitalul Clinic Judetean Mures
- Clinic Center of SerbiaRecruiting
- Clinical Hospital Center "Dr. Dragisa Misovic"Recruiting
- Euromedik HospitalRecruiting
- Zvezdara University Medical Center
- Clinical Center Kragujevac - Center for GastroenterohepatologyRecruiting
- General Hospital Dr Djordje JoanovicRecruiting
- General hospital Zrenjanin
- FNsP F.D.R. Banska BystricaRecruiting
- CLINIQ s.r.o.Recruiting
- ENDOMED s.r.o.Recruiting
- GASTROMEDIC, s.r.o.Recruiting
- Accout Center s.r.o.Recruiting
- Karolinska Universitetssjukhuset - Gastroenterology
- Uppsala University Hospital, AkademiskaRecruiting
- Örebro Univ. HospitalRecruiting
- Hacettepe University Medical Faculty - HematologyRecruiting
- Istanbul University Medical FacultyRecruiting
- Mersin Universtiy Medical Faculty
- Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology
- Accellacare Warwickshire Quality Research Site
- County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital
- Glasgow Royal Infirmary
- North West London Hospitals NHS Trust
- Central Middlesex Hospital
- Kings College Hospital
- Accellacare North London
- Accellacare Limited/Accellacare of South London
- Royal Berkshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Cobitolimod 250 mg
Cobitolimod 500 mg
Placebo
Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week
Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week
Dose of Placebo 2 treatments during induction study and subsequently every third week