The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT04985968
- Lead Sponsor
- InDex Pharmaceuticals
- Brief Summary
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.
- Detailed Description
This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 171
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cobitolimod 250 mg Cobitolimod 250 mg Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week Placebo Placebo Dose of Placebo 2 treatments during induction study and subsequently every third week Cobitolimod 500 mg Cobitolimod 500 mg Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week
- Primary Outcome Measures
Name Time Method Induction - Proportion of participants with clinical remission. Week 6 Clinical remission defined by the 3-component Mayo score.
Maintenance - Proportion of participants with clinical remission. Week 52 Clinical remission defined by the 3-component Mayo score.
- Secondary Outcome Measures
Name Time Method Induction - Proportion of participants with symptomatic remission. Week 6 Symptomatic remission defined by the 2-component Mayo score.
Induction - Mean stool frequency. Week 6 Mean stool frequency defined by the Mayo score for Stool Frequency.
Induction - Proportion of participants with histologic remission. Week 6 Histologic remission defined by the Robarts Histologic Index.
Induction - Proportion of participants with mucosal healing. Week 6 Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Induction - Mean IBDQ total score. Week 6 Defined by the Inflammatory Bowel Disease Questionnaire (IBDQ).
Maintenance - Proportion of participants with clinical remission and steroid-free. Week 52 Defined by the 3-component Mayo score and use of glucocorticosteroids.
Induction - Proportion of participants with endoscopic improvement. Week 6 Endoscopic improvement defined by the Mayo Endoscopic score.
Induction - Proportion of participants with clinical response. Week 6 Clinical remission defined by the 3-component Mayo score.
Induction - Proportion of participants with normalisation of stool frequency. Week 6 Stool frequency defined by the Mayo score for Stool Frequency.
Induction - Proportion of participants with absence of rectal bleeding. Week 6 Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Induction - Proportion of participants with histologic improvement. Week 6 Defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with histologic improvement. Week 52 Histologic improvement defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with clinical response. Week 52 Clinical response defined by the 3-component Mayo score.
Maintenance - Proportion of participants with absence of rectal bleeding. Week 52 Rectal bleeding defined by the Mayo score for Rectal Bleeding.
Maintenance - Mean 3-component and 4-component Mayo scores. Week 52 Defined by 3-component and 4-component Mayo scores.
Induction - Mean ln-transformed faecal calprotectin. Week 6 Mean ln-transformed faecal calprotectin defined by faecal calprotectin values.
Induction - Mean 3-component and 4-component Mayo scores. Week 6 Defined by 3-component and 4-component Mayo scores.
Induction - Proportion of participants with an improvement in IBDQ total score. Week 6 Defined by the IBDQ.
Maintenance - Proportion of participants with endoscopic improvement. Week 52 Endoscopic improvement defined by the Mayo Endoscopic score.
Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission Week 52 Defined by the 3-component Mayo score.
Maintenance - Proportion of participants with symptomatic remission. Week 52 Symptomatic remission defined by the 2-component Mayo score.
Maintenance - Proportion of participants with histologic remission. Week 52 Histologic remission defined by the Robarts Histologic Index.
Maintenance - Proportion of participants with mucosal healing. Week 52 Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.
Maintenance - Proportion of participants with normalisation of stool frequency. Week 52 Stool frequency defined by the Mayo score for Stool Frequency.
Maintenance - Mean stool frequency. Week 52 Mean stool frequency defined by the Mayo score for Stool Frequency.
Maintenance - Mean ln-transformed faecal calprotectin. Week 52 Mean ln-transformed faecal calprotectin.
Maintenance - Mean IBDQ total score. Week 52 Defined by the use of the Inflammatory Bowel Disease Questionnaire (IBDQ).
Maintenance - Proportion of participants with an improvement in IBDQ total score. Week 52 Defined by the IBDQ.
Trial Locations
- Locations (202)
Opca bolnica Bjelovar
🇭🇷Bjelovar, Croatia
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
Clinical Hospital Osijek
🇭🇷Osijek, Croatia
Zadar General Hospital
🇭🇷Zadar, Croatia
Poliklinika Solmed
🇭🇷Zagreb, Croatia
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
🇭🇺Budapest, Hungary
The Barzilai Medical Center
🇮🇱Ashkelon, Israel
Klaipeda Seamen's Hospital
🇱🇹Klaipeda, Lithuania
Republic Klaipeda Hospital
🇱🇹Klaipeda, Lithuania
Clinical Research Institute S.C.
🇲🇽Tlalnepantla, Mexico
Vestfold Hjertesenter As
🇳🇴Tønsberg, Norway
Panevezio ligonine
🇱🇹Panevezys, Lithuania
Vilniaus Universiteto ligonines Santariskiu Klinikos
🇱🇹Vilnius, Lithuania
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
🇲🇽Durango, Mexico
Medical Care and Research S. A. de C. V
🇲🇽Merida, Mexico
MZ Badania Slowik Zymla Spolka jawna
🇵🇱Knurow, Poland
Centrum Medyczne PROMED
🇵🇱Krakow, Poland
Clinicos Asociados Bocm, S.C.
🇲🇽Mexico City, Mexico
Krakowskie Centrum Medyczne Sp. z o.o.
🇵🇱Krakow, Poland
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
General hospital Zrenjanin
🇷🇸Zrenjanin, Serbia
Medicome Sp. z o.o.
🇵🇱Oswiecim, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
🇵🇱Poznan, Poland
Hospital Beatriz Angelo (HBA)
🇵🇹Loures, Portugal
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi
🇷🇴Iasi, Romania
Cabinet Particular Policlinic Algomed
🇷🇴Timişoara, Romania
Spitalul Clinic Judetean Mures
🇷🇴Târgu Mureș, Romania
Clinical Hospital Center "Dr. Dragisa Misovic"
🇷🇸Belgrade, Serbia
KO-MED Centra Kliniczne Staszow
🇵🇱Staszow, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Euromedik Hospital
🇷🇸Belgrade, Serbia
CLINIQ s.r.o.
🇸🇰Bratislava, Slovakia
Twoja Przychodnia - SCM
🇵🇱Szczecin, Poland
Sana Monitoring
🇷🇴Bucuresti, Romania
FNsP F.D.R. Banska Bystrica
🇸🇰Banska Bystrica, Slovakia
ENDOMED s.r.o.
🇸🇰Košice, Slovakia
GASTROMEDIC, s.r.o.
🇸🇰Nove Zamky, Slovakia
Accout Center s.r.o.
🇸🇰Sahy, Slovakia
Baylor College of Medicine - Gastroeneterology
🇺🇸Houston, Texas, United States
Accellacare North London
🇬🇧Northwood, United Kingdom
Carolina Research
🇺🇸Greenville, North Carolina, United States
Carolina Digestive Health Associates, PA
🇺🇸Charlotte, North Carolina, United States
Allameh Medical Corporation
🇺🇸Mission Viejo, California, United States
Clinical Research Institute of Michigan
🇺🇸Troy, Michigan, United States
RecioMed Clinical Research Network, Inc.
🇺🇸Boynton Beach, Florida, United States
Prospective Research Innovations Inc.
🇺🇸Rancho Cucamonga, California, United States
Cotton O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
MB & V Medical Research
🇺🇸Doral, Florida, United States
Amicis Research Center
🇺🇸Granada Hills, California, United States
Gastroenterology Group Of Naples
🇺🇸Naples, Florida, United States
Clinical Research Solution: Digestive Health Associates
🇺🇸Houston, Texas, 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
Monash Health
🇦🇺Clayton, Australia
Gastroenterology Associates of Northern Virginia
🇺🇸Fairfax, Virginia, United States
UZ Antwerpen
🇧🇪Antwerpen, Belgium
MUMC - Hamilton Health Sciences
🇨🇦Hamilton, Canada
The Alfred Hospital
🇦🇺Melbourne, Australia
Installation Hospital Maisonneuve-Rosemont
🇨🇦Montréal, Canada
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
AZ Groeninge - Campus Kennedylaan
🇧🇪Kortrijk, Belgium
St Vincent's Hospital Melbourne
🇦🇺Fitzroy, Australia
Universitätsklinikum Salzburg
🇦🇹Salzburg, Austria
Erasme University Hospital
🇧🇪Brussels, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
MedUn Innsbruck
🇦🇹Innsbruck, Austria
LKH Klagenfurt
🇦🇹Klagenfurt, Austria
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
The University Hospital Foca
🇧🇦Foca, Bosnia and Herzegovina
Akh Wien
🇦🇹Wien, Austria
Clinical Center University of Sarajevo - Gastroenterology
🇧🇦Sarajevo, Bosnia and Herzegovina
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
🇧🇷Porto Alegre, Brazil
Kaiser Clinica
🇧🇷Sao Jose do Rio Preto, Brazil
Opca Bolnica Tesanj
🇧🇦Tesanj, Bosnia and Herzegovina
CEMEC - Centro Multidisciplinar de Estudos Clinicos
🇧🇷São Bernardo do Campo, Brazil
Opca bolnica Pula
🇭🇷Pula, Croatia
LTD Israel-Georgian Medical Research Clinic Helsicore
🇬🇪Tiflis, Georgia
Aalborg University Hospital
🇩🇰Aalborg, Denmark
CHU de Nancy Brabois
🇫🇷Nancy, France
Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.
🇭🇺Budapest, Hungary
The Edith Wolfson Medical Center
🇮🇱H̱olon, Israel
Herlev Hospital
🇩🇰Herlev, Denmark
MVZ Sanaklinikum Duisburg
🇩🇪Duisburg, Germany
Lillebælt Hospital Vejle
🇩🇰Vejle, Denmark
IRCCS Ospedale San Raffaele
🇮🇹Milan, Italy
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-Si, Korea, Republic of
Internistische Praxis Weyhe
🇩🇪Weyhe, Germany
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-Si, Korea, Republic of
JSC " Evex Hospitals"
🇬🇪Batumi, Georgia
Azienda Ospedaliera San Gerardo
🇮🇹Monza, Italy
ASST Papa Giovanni XXIII - Cardiologia - Bergamo
🇮🇹Bergamo, Italy
Pannónia Magánorvosi Centrum Kft
🇭🇺Budapest, Hungary
Universitätsklinikum Augsburg
🇩🇪Augsburg, Germany
SzTE Szt-Gy A Orvostud Kar Bel Klin
🇭🇺Szeged, Hungary
Hadassah Medical Organization, Hadassah Medical Center, Ein-
🇮🇱Jerusalem, Israel
Universita degli Studi di Firenze - Azienda Ospedaliero - Un
🇮🇹Firenze, Italy
Universita degli Studi dell'Insubria - Ospedale di Circolo e
🇮🇹Varese, Italy
Medius Klinik Nürtingen
🇩🇪Nürtingen, Germany
Kyung Hee University Hospital
🇰🇷Soeul, Korea, Republic of
Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P
🇮🇹Roma, Italy
AO Brotzu
🇮🇹Cagliari, Italy
AOU di Padova
🇮🇹Padova, Italy
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Kyung Hee University Hospital - Internal Medicine
🇰🇷Soeul, Korea, Republic of
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
🇭🇺Budapest, Hungary
Universitätsklinikum Rostock
🇩🇪Rostock, Germany
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Yonsei University, Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Twoja Przychodnia - Opolskie Centrum Medyczne
🇵🇱Opole, Poland
Uppsala University Hospital, Akademiska
🇸🇪Uppsala, Sweden
Örebro Univ. Hospital
🇸🇪Örebro, Sweden
County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital
🇬🇧Darlington, United Kingdom
North West London Hospitals NHS Trust
🇬🇧Harrow, United Kingdom
Karolinska Universitetssjukhuset - Gastroenterology
🇸🇪Stockholm, Sweden
Hacettepe University Medical Faculty - Hematology
🇹🇷Ankara, Turkey
Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology
🇬🇧Bury, United Kingdom
Istanbul University Medical Faculty
🇹🇷Istanbul, Turkey
Mersin Universtiy Medical Faculty
🇹🇷Mersin, Turkey
Kings College Hospital
🇬🇧London, United Kingdom
Central Middlesex Hospital
🇬🇧London, United Kingdom
Accellacare Warwickshire Quality Research Site
🇬🇧Coventry, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Policlinico Universitario Campus Biomedico
🇮🇹Rom, Italy
A.O. Ordine Mauriziano Di Torino
🇮🇹Torino, Italy
AOU S. Maria della Misericordia
🇮🇹Udine, Italy
CHRU de Lille - Hôpital Claude Huriez
🇫🇷Lille, France
Hopital Bichat - Gastroenterology
🇫🇷Paris, France
CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie
🇫🇷Montpellier, France
CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie
🇫🇷Nice, France
Hopital Saint Antoine
🇫🇷Paris Cedex 12, France
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
🇫🇷Toulouse, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite Cedex, France
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
🇧🇷Goiania, Brazil
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt am main, Germany
Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I
🇩🇪Frankfurt am Main, Germany
University Hospital Schleswig-Holstein
🇩🇪Kiel, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Royal Melbourne Hospital
🇦🇺Parkville, Australia
Mater Health Services
🇦🇺South Brisbane, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Valiance Clinical Research
🇺🇸Tarzana, California, United States
Royal University Hospital
🇨🇦Saskatoon, Canada
Lenox Hill Hospital
🇺🇸New York, New York, United States
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Ufrj - Hospital Universitario Clementino Fraga Filho
🇧🇷Rio De Janeiro, Brazil
Hillerod Hospital
🇩🇰Hillerød, Denmark
Praxis Pesquisa Medica
🇧🇷Santo Andre, Brazil
University Hospital Cologne AöR
🇩🇪Cologne, Germany
CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog
🇫🇷Salouel, France
Uniklinik Halle (Saale)
🇩🇪Halle, Germany
Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt
🇩🇪Heidelberg, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Germany
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Charité - Universitätsmedizin Berlin KöR
🇩🇪Berlin, Germany
CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie
🇫🇷Saint-Étienne, France
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Centro Regiomontano de Estudios Clinicos Roma SC
🇲🇽Monterrey, Mexico
Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8
🇳🇴Tromsø, Norway
Akershus Universitetssykehus
🇳🇴Lørenskog, Norway
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
MPS - MED sp. z o.o.
🇵🇱Grudziadz, Poland
Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR
🇳🇴Ålesund, Norway
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi
🇵🇱Lodz, Poland
ETG Skierniewice
🇵🇱Skierniewice, Poland
Centrum Zdrowia Matki, Dziecka i Mlodziezy
🇵🇱Warsaw, Poland
Bodyclinic sp. z o.o. sp.k.
🇵🇱Warszawa, Poland
Centralny Szpital Kliniczny MSWiA w Warszawie
🇵🇱Warszawa, Poland
PlanetMed
🇵🇱Wroclaw, Poland
Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)
🇵🇹Amadora, Portugal
Spitalul Clinic Colentina
🇷🇴Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Clinic Center of Serbia
🇷🇸Belgrade, Serbia
Zvezdara University Medical Center
🇷🇸Belgrad, Serbia
General Hospital Dr Djordje Joanovic
🇷🇸Zrenjanin, Serbia
Accellacare Limited/Accellacare of South London
🇬🇧Orpington, United Kingdom
Alliance Clinical Research - Gastroenterology
🇺🇸Tampa, Florida, United States
A+ Research, Inc.
🇺🇸Miami, Florida, United States
Medical Professionals Clinical Research Center
🇺🇸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
Wisconsin Center For Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Kaplan Medical Center
🇮🇱Rehovot, Israel
University Clinical Centre of the Republic of Srpska - Gastroenterology
🇧🇦Banja Luka, Bosnia and Herzegovina
General Hospital "Prim.dr.Abdulah Nakas"
🇧🇦Sarajevo, Bosnia and Herzegovina
Polyclinic Dr. Al-Tawil
🇧🇦Sarajevo, Bosnia and Herzegovina
Plava Medical Group
🇧🇦Tuzla, Bosnia and Herzegovina
Cantonal Hospital Zenica
🇧🇦Zenica, Bosnia and Herzegovina
Galilee Medical Center (Western Galilee Hospital)
🇮🇱Nahariya, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
🇱🇹Kaunas, Lithuania
Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
🇵🇱Malbork, Poland
GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie
🇵🇱Torun, Poland
ETG Zamosc
🇵🇱Zamosc, Poland
Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião
🇵🇹Santa Maria da Feira, Portugal
Clinical Center Kragujevac - Center for Gastroenterohepatology
🇷🇸Kragujevac, Serbia