The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis (CONCLUDE)

A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Cobitolimod 250 mg; Drug: Cobitolimod 500 mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Clayton, Australia
    • Monash Health
  • Fitzroy, Australia
    • St Vincent's Hospital Melbourne
  • Melbourne, Australia
    • The Alfred Hospital
  • Parkville, Australia
    • Royal Melbourne Hospital
  • South Brisbane, Australia
    • Mater Health Services
  • Woolloongabba, Australia
    • Princess Alexandra Hospital
• Austria
  • Innsbruck, Austria
    • MedUn Innsbruck
  • Klagenfurt, Austria
    • LKH Klagenfurt
  • Salzburg, Austria
    • Universitätsklinikum Salzburg
  • Wien, Austria
    • AKH Wien
• Belgium
  • Antwerpen, Belgium
    • UZ Antwerpen
  • Bonheiden, Belgium
    • Imelda Ziekenhuis
  • Brussels, Belgium
    • Erasme University Hospital
  • Gent, Belgium
    • Universitair Ziekenhuis Gent
  • Kortrijk, Belgium
    • AZ Groeninge - campus kennedylaan
  • Roeselare, Belgium
    • AZ Delta
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina
    • University Clinical Centre of the Republic of Srpska - Gastroenterology
  • Foca, Bosnia and Herzegovina
    • The University Hospital Foca
  • Sarajevo, 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
  • Tesanj, Bosnia and Herzegovina
    • Opca Bolnica Tesanj
  • Tuzla, Bosnia and Herzegovina
    • Plava Medical Group
  • Zenica, Bosnia and Herzegovina
    • Cantonal Hospital Zenica
• Brazil
  • Goiania, Brazil
    • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
  • Porto Alegre, Brazil
    • Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
  • Rio De Janeiro, Brazil
    • Ufrj - Hospital Universitario Clementino Fraga Filho
  • Santo Andre, Brazil
    • Praxis pesquisa médica
  • Sao Jose do Rio Preto, Brazil
    • Kaiser Clinica
  • São Bernardo do Campo, Brazil
    • CEMEC - Centro Multidisciplinar de Estudos Clínicos
• Canada
  • Hamilton, Canada
    • MUMC - Hamilton Health Sciences
  • Montréal, Canada
    • Installation Hospital Maisonneuve-Rosemont
  • Saskatoon, Canada
    • Royal University Hospital
• Croatia
  • Bjelovar, Croatia
    • Opca bolnica Bjelovar
  • Osijek, Croatia
    • Clinical Hospital Osijek
  • Pula, Croatia
    • Opca bolnica Pula
  • Zadar, Croatia
    • Zadar General Hospital
  • Zagreb, Croatia
    • University Hospital Centre Zagreb
  • Zagreb, Croatia
    • Poliklinika Solmed
• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Aarhus University Hospital
  • Herlev, Denmark
    • Herlev Hospital
  • Hillerød, Denmark
    • Hillerod Hospital
  • Vejle, Denmark
    • Lillebælt Hospital Vejle
• France
  • Lille, France
    • CHRU de Lille - Hopital Claude Huriez
  • Montpellier, France
    • CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie
  • Nancy, France
    • CHU de Nancy Brabois
  • Nice, France
    • CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie
  • Paris, France
    • Hopital Bichat - Gastroenterology
  • Paris Cedex 12, France
    • Hôpital Saint Antoine
  • Pierre Benite Cedex, France
    • Centre Hospitalier Lyon Sud
  • Poitiers, France
    • Centre Hospitalier Universitaire de Poitiers
  • Saint-Étienne, France
    • CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie
  • Salouel, France
    • CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog
  • Toulouse, France
    • Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil
• Georgia
  • Batumi, Georgia
    • JSC " Evex Hospitals"
  • Tiflis, Georgia
    • LTD Israel-Georgian Medical Research Clinic Helsicore
• Germany
  • Augsburg, Germany
    • Universitätsklinikum Augsburg
  • Berlin, Germany
    • Charité - Universitätsmedizin Berlin KöR
  • Cologne, Germany
    • University Hospital Cologne AöR
  • Duisburg, Germany
    • MVZ Sanaklinikum Duisburg
  • Erlangen, Germany
    • Universitätsklinikum Erlangen
  • Frankfurt am Main, Germany
    • Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I
  • Frankfurt am main, Germany
    • Agaplesion Markus Krankenhaus
  • Freiburg, Germany
    • Universitätsklinikum Freiburg
  • Halle, Germany
    • Uniklinik Halle (Saale)
  • Heidelberg, Germany
    • Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt
  • Kiel, Germany
    • University Hospital Schleswig-Holstein
  • Mannheim, Germany
    • Universitätsmedizin Mannheim
  • Nürtingen, Germany
    • Medius Klinik Nurtingen
  • Rostock, Germany
    • Universitätsklinikum Rostock
  • Ulm, Germany
    • Universitätsklinikum Ulm
  • Weyhe, Germany
    • Internistische Praxis Weyhe
• Hungary
  • Budapest, Hungary
    • Semmelweis Egyetem Általános Orvostudományi Kar
  • Budapest, Hungary
    • Pannónia Magánorvosi Centrum Kft
  • Budapest, Hungary
    • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
  • Budapest, Hungary
    • Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
  • Szeged, Hungary
    • SzTE Szt-Gy A Orvostud Kar Bel Klin
• Israel
  • Ashkelon, Israel
    • The Barzilai Medical Center
  • H̱olon, Israel
    • The Edith Wolfson Medical Center
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
  • Jerusalem, Israel
    • Hadassah Medical Organization, Hadassah Medical Center, Ein-
  • Nahariya, Israel
    • Galilee Medical Center (Western Galilee Hospital)
  • Rehovot, Israel
    • Kaplan Medical Center
• Italy
  • Bergamo, Italy
    • ASST Papa Giovanni XXIII - Cardiologia - Bergamo
  • Cagliari, Italy
    • AO Brotzu
  • Firenze, Italy
    • Universita degli Studi di Firenze - Azienda Ospedaliero - Un
  • Milan, Italy
    • IRCCS Ospedale San Raffaele
  • Monza, Italy
    • Azienda Ospedaliera San Gerardo
  • Padova, Italy
    • AOU di Padova
  • Rom, Italy
    • Policlinico Universitario Campus Biomedico
  • Roma, Italy
    • Policlinico Universitario Agostino Gemelli
  • Roma, Italy
    • Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P
  • Torino, Italy
    • A.O. Ordine Mauriziano di Torino
  • Udine, Italy
    • AOU S. Maria della Misericordia
  • Varese, Italy
    • Universita degli Studi dell'Insubria - Ospedale di Circolo e
• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Haeundae Paik Hospital
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Guri-Si, Korea, Republic of
    • Hanyang University Guri Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Kyung Hee University Hospital
  • Soeul, Korea, Republic of
    • Kyung Hee University Hospital - Internal Medicine
  • Soeul, Korea, Republic of
    • Kyung Hee University Hospital
  • Suwon-Si, Korea, Republic of
    • The Catholic university of Korea, St. Vincent's Hospital
  • Wŏnju, Korea, Republic of
    • Yonsei University, Wonju Severance Christian Hospital
• Lithuania
  • Kaunas, Lithuania
    • Hospital of Lithuanian University of Health Sciences Kauno klinikos
  • Klaipeda, Lithuania
    • Klaipeda Seamen's Hospital
  • Klaipeda, Lithuania
    • Republic Klaipeda Hospital
  • Panevezys, Lithuania
    • Panevezio ligonine
  • Vilnius, Lithuania
    • Vilniaus Universiteto ligonines Santariskiu Klinikos
• Mexico
  • Durango, Mexico
    • Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
  • Merida, Mexico
    • Medical Care and Research S. A. de C. V
  • Mexico City, Mexico
    • Clinicos Asociados Bocm, S.C.
  • Monterrey, Mexico
    • Centro Regiomontano de Estudios Clinicos Roma SC
  • Tlalnepantla, Mexico
    • Clinical Research Institute S.C.
• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Center
• Norway
  • Lørenskog, Norway
    • Akershus Universitetssykehus
  • Tromsø, Norway
    • Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8
  • Tønsberg, Norway
    • Vestfold Hjertesenter As
  • Ålesund, Norway
    • Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR
• Poland
  • Grudziadz, Poland
    • MPS - MED sp. z o.o.
  • Knurow, Poland
    • MZ Badania Slowik Zymla Spolka Jawna
  • Krakow, Poland
    • Centrum Medyczne Promed
  • Krakow, Poland
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Kraków, Poland
    • Centrum Medyczne Plejady
  • Lodz, Poland
    • Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi
  • Malbork, Poland
    • Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.
  • Opole, Poland
    • Twoja Przychodnia - Opolskie Centrum Medyczne
  • Oswiecim, Poland
    • Medicome Sp. Z O.O.
  • Poznan, Poland
    • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Skierniewice, Poland
    • ETG Skierniewice
  • Staszow, Poland
    • KO-MED Centra Kliniczne Staszow
  • Szczecin, Poland
    • Twoja Przychodnia - SCM
  • Torun, Poland
    • GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie
  • Warsaw, Poland
    • Centrum Zdrowia Matki, Dziecka i Mlodziezy
  • Warszawa, Poland
    • Bodyclinic sp. z o.o. sp.k.
  • Warszawa, Poland
    • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Wroclaw, Poland
    • Planetmed
  • Zamosc, Poland
    • ETG Zamosc
• Portugal
  • Amadora, Portugal
    • Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)
  • Braga, Portugal
    • Hospital de Braga
  • Loures, Portugal
    • Hospital Beatriz Angelo (HBA)
  • Santa Maria da Feira, Portugal
    • Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião
• Romania
  • Bucharest, Romania
    • Spitalul Clinic Colentina
  • Bucuresti, Romania
    • Sana Monitoring
  • Cluj-Napoca, Romania
    • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Iasi, Romania
    • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi
  • Timişoara, Romania
    • Cabinet Particular Policlinic Algomed
  • Târgu Mureș, Romania
    • Spitalul Clinic Judetean Mures
• Serbia
  • Belgrad, Serbia
    • Zvezdara University Medical Center
  • Belgrade, Serbia
    • Clinic Center of Serbia
  • Belgrade, Serbia
    • Clinical Hospital Center "Dr. Dragisa Misovic"
  • Belgrade, Serbia
    • Euromedik Hospital
  • Kragujevac, Serbia
    • Clinical Center Kragujevac - Center for Gastroenterohepatology
  • Zrenjanin, Serbia
    • General Hospital Dr Djordje Joanovic
  • Zrenjanin, Serbia
    • General Hospital Zrenjanin
• Slovakia
  • Banska Bystrica, Slovakia
    • FNsP F.D.R. Banska Bystrica
  • Bratislava, Slovakia
    • Cliniq s.r.o.
  • Košice, Slovakia
    • ENDOMED s.r.o.
  • Nove Zamky, Slovakia
    • Gastromedic, s.r.o.
  • Sahy, Slovakia
    • Accout Center s.r.o.
• Sweden
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset - Gastroenterology
  • Uppsala, Sweden
    • Uppsala University Hospital, Akademiska
  • Örebro, Sweden
    • Örebro Univ. Hospital
• Turkey
  • Ankara, Turkey
    • Hacettepe University Medical Faculty - Hematology
  • Istanbul, Turkey
    • Istanbul University Medical Faculty
  • Mersin, Turkey
    • Mersin Universtiy Medical Faculty
• United Kingdom
  • Bury, United Kingdom
    • Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology
  • Coventry, United Kingdom
    • Accellacare Warwickshire Quality Research Site
  • Darlington, United Kingdom
    • County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital
  • Glasgow, United Kingdom
    • Glasgow Royal Infirmary
  • Harrow, United Kingdom
    • North West London Hospitals NHS Trust
  • London, United Kingdom
    • Kings College Hospital
  • London, United Kingdom
    • Central Middlesex Hospital
  • Northwood, United Kingdom
    • Accellacare North London
  • Orpington, United Kingdom
    • Accellacare Limited/Accellacare of South London
  • Reading, United Kingdom
    • Royal Berkshire Hospital
• United States
  • California
    • Granada Hills, California, United States, 91344
      • Amicis Research Center
    • Mission Viejo, California, United States, 92691
      • Allameh Medical Corporation
    • Rancho Cucamonga, California, United States, 91730
      • Prospective Research Innovations Inc.
    • Tarzana, California, United States, 91356
      • Valiance Clinical Research
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Reciomed Clinical Research Network, Inc.
    • Doral, Florida, United States, 33172
      • MB & V Medical Research
    • Miami, Florida, United States, 33136
      • SouthCoast Research Center, Inc
    • Miami, Florida, United States, 33012
      • A+ Research, Inc.
    • Miami, Florida, United States, 33144
      • I.V.A.M. Clinical & Investigational Center LLC
    • Miami, Florida, United States, 33155
      • D&H National Research Centers, Inc.
    • Miami, Florida, United States, 33165
      • Medical Professionals Clinical Research Center
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Of Naples
    • Tampa, Florida, United States, 33615
      • Alliance Clinical Research - Gastroenterology
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center
  • Michigan
    • Troy, Michigan, United States, 48098
      • Clinical Research Institute of Michigan
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Carolina Digestive Health Associates, PA
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Dayton Gastroenterology
  • Texas
    • Carrollton, Texas, United States, 75019
      • Digestive Health Associates of Texas, PA
    • Houston, Texas, United States, 77024
      • Clinical Research Solution: Digestive Health Associates
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Gastroeneterology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Gastroenterology Associates of Northern Virginia
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cobitolimod 250 mg; Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week	Drug: Cobitolimod 250 mg; Rectal administration; Other Names: Kappaproct
Experimental: Cobitolimod 500 mg; Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week	Drug: Cobitolimod 500 mg; Rectal administration; Other Names: Kappaproct
Placebo Comparator: Placebo; Dose of Placebo 2 treatments during induction study and subsequently every third week	Drug: Placebo; Rectal administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction - Proportion of participants with clinical remission.	Clinical remission defined by the 3-component Mayo score.	Week 6
Maintenance - Proportion of participants with clinical remission.	Clinical remission defined by the 3-component Mayo score.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction - Proportion of participants with endoscopic improvement.	Endoscopic improvement defined by the Mayo Endoscopic score.	Week 6
Induction - Proportion of participants with symptomatic remission.	Symptomatic remission defined by the 2-component Mayo score.	Week 6
Induction - Proportion of participants with clinical response.	Clinical remission defined by the 3-component Mayo score.	Week 6
Induction - Proportion of participants with normalisation of stool frequency.	Stool frequency defined by the Mayo score for Stool Frequency.	Week 6
Induction - Proportion of participants with absence of rectal bleeding.	Rectal bleeding defined by the Mayo score for Rectal Bleeding.	Week 6
Induction - Mean stool frequency.	Mean stool frequency defined by the Mayo score for Stool Frequency.	Week 6
Induction - Proportion of participants with histologic improvement.	Defined by the Robarts Histologic Index.	Week 6
Induction - Proportion of participants with histologic remission.	Histologic remission defined by the Robarts Histologic Index.	Week 6
Induction - Proportion of participants with mucosal healing.	Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.	Week 6
Induction - Mean ln-transformed faecal calprotectin.	Mean ln-transformed faecal calprotectin defined by faecal calprotectin values.	Week 6
Induction - Mean 3-component and 4-component Mayo scores.	Defined by 3-component and 4-component Mayo scores.	Week 6
Induction - Mean IBDQ total score.	Defined by the Inflammatory Bowel Disease Questionnaire (IBDQ).	Week 6
Induction - Proportion of participants with an improvement in IBDQ total score.	Defined by the IBDQ.	Week 6
Maintenance - Proportion of participants with endoscopic improvement.	Endoscopic improvement defined by the Mayo Endoscopic score.	Week 52
Maintenance - Proportion of participants with clinical remission and steroid-free.	Defined by the 3-component Mayo score and use of glucocorticosteroids.	Week 52
Maintenance - Proportion of participants with clinical remission among those who achieved clinical remission	Defined by the 3-component Mayo score.	Week 52
Maintenance - Proportion of participants with symptomatic remission.	Symptomatic remission defined by the 2-component Mayo score.	Week 52
Maintenance - Proportion of participants with histologic improvement.	Histologic improvement defined by the Robarts Histologic Index.	Week 52
Maintenance - Proportion of participants with histologic remission.	Histologic remission defined by the Robarts Histologic Index.	Week 52
Maintenance - Proportion of participants with mucosal healing.	Mucosal healing defined by the Mayo Endoscopic score and Robarts Histologic Index.	Week 52
Maintenance - Proportion of participants with clinical response.	Clinical response defined by the 3-component Mayo score.	Week 52
Maintenance - Proportion of participants with absence of rectal bleeding.	Rectal bleeding defined by the Mayo score for Rectal Bleeding.	Week 52
Maintenance - Proportion of participants with normalisation of stool frequency.	Stool frequency defined by the Mayo score for Stool Frequency.	Week 52
Maintenance - Mean stool frequency.	Mean stool frequency defined by the Mayo score for Stool Frequency.	Week 52
Maintenance - Mean ln-transformed faecal calprotectin.	Mean ln-transformed faecal calprotectin.	Week 52
Maintenance - Mean 3-component and 4-component Mayo scores.	Defined by 3-component and 4-component Mayo scores.	Week 52
Maintenance - Mean IBDQ total score.	Defined by the use of the Inflammatory Bowel Disease Questionnaire (IBDQ).	Week 52
Maintenance - Proportion of participants with an improvement in IBDQ total score.	Defined by the IBDQ.	Week 52

Collaborators and Investigators

• Sponsor: InDex Pharmaceuticals
• Investigators: Principal Investigator: Raja Atreya, Professor, Friedrich-Alexander University Erlangen-Nuremberg

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Diseases; Gastrointestinal Disease; Colitis, Ulcerative; Glucocorticosteroids; Anti-Inflammatory Agents; TLR9 agonist; Therapeutic uses; Kappaproct; IDX0150; DIMS0150; Cobitolimod; Toll like receptor 9 agonist
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CSUC-01/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No