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

NCT04985968 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: CSUC-01/21
• Study Type: interventional
• Target: 171
• Locations: 26 countries
• Sites: 190

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.

Conditions

Ulcerative Colitis

Keywords

Colitis, Ulcerative; Gastrointestinal Disease; Inflammatory Bowel Diseases; Glucocorticosteroids; Anti-Inflammatory Agents; Therapeutic uses; Cobitolimod; Toll like receptor 9 agonist; TLR9 agonist; Kappaproct; IDX0150; DIMS0150

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (28)

• Induction - Proportion of participants with endoscopic improvement.

  Week 6

• Induction - Proportion of participants with symptomatic remission.

  Week 6

• Induction - Proportion of participants with clinical response.

  Week 6

• Induction - Proportion of participants with normalisation of stool frequency.

  Week 6

• Induction - Proportion of participants with absence of rectal bleeding.

  Week 6

Study Arms (3)

Cobitolimod 250 mg

EXPERIMENTAL

Dose of 250 mg cobitolimod 2 treatments during induction study and subsequently every third week

Drug: Cobitolimod 250 mg

Cobitolimod 500 mg

EXPERIMENTAL

Dose of 500 mg cobitolimod 2 treatments during induction study and subsequently every third week

Drug: Cobitolimod 500 mg

Placebo

PLACEBO COMPARATOR

Dose of Placebo 2 treatments during induction study and subsequently every third week

Drug: Placebo

Interventions

Cobitolimod 250 mg DRUG

Rectal administration

Also known as: Kappaproct

Cobitolimod 250 mg

Cobitolimod 500 mg DRUG

Rectal administration

Also known as: Kappaproct

Cobitolimod 500 mg

Placebo DRUG

Rectal administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InDex Pharmaceuticals: lead

Study Sites (203)

Amicis Research Center

Granada Hills, California, 91344, United States

Location

Allameh Medical Corporation

Mission Viejo, California, 92691, United States

Location

Prospective Research Innovations Inc.

Rancho Cucamonga, California, 91730, United States

Location

Valiance Clinical Research

Tarzana, California, 91356, United States

Location

RecioMed Clinical Research Network, Inc.

Boynton Beach, Florida, 33472, United States

Location

MB & V Medical Research

Doral, Florida, 33172, United States

Location

A+ Research, Inc.

Miami, Florida, 33012, United States

Location

SouthCoast Research Center, Inc

Miami, Florida, 33136, United States

Location

I.V.A.M. Clinical & Investigational Center LLC

Miami, Florida, 33144, United States

Location

D&H National Research Centers, Inc.

Miami, Florida, 33155, United States

Location

Medical Professionals Clinical Research Center

Miami, Florida, 33165, United States

Location

Gastroenterology Group Of Naples

Naples, Florida, 34102, United States

Location

Alliance Clinical Research - Gastroenterology

Tampa, Florida, 33615, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Clinical Research Institute of Michigan

Troy, Michigan, 48098, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Carolina Digestive Health Associates, PA

Charlotte, North Carolina, 28209, United States

Location

Carolina Research

Greenville, North Carolina, 27834, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Dayton Gastroenterology

Beavercreek, Ohio, 45440, United States

Location

Digestive Health Associates of Texas, PA

Carrollton, Texas, 75019, United States

Location

Clinical Research Solution: Digestive Health Associates

Houston, Texas, 77024, United States

Location

Baylor College of Medicine - Gastroeneterology

Houston, Texas, 77030, United States

Location

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Wisconsin Center For Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Monash Health

Clayton, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Royal Melbourne Hospital

Parkville, Australia

Location

Mater Health Services

South Brisbane, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Australia

Location

MedUn Innsbruck

Innsbruck, Austria

Location

LKH Klagenfurt

Klagenfurt, Austria

Location

Universitätsklinikum Salzburg

Salzburg, Austria

Location

Akh Wien

Vienna, Austria

Location

UZ Antwerpen

Antwerp, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

Erasme University Hospital

Brussels, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

AZ Groeninge - Campus Kennedylaan

Kortrijk, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

University Clinical Centre of the Republic of Srpska - Gastroenterology

Banja Luka, Bosnia and Herzegovina

Location

The University Hospital Foca

Foča, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo - Gastroenterology

Sarajevo, Bosnia and Herzegovina

Location

General Hospital "Prim.dr.Abdulah Nakas"

Sarajevo, Bosnia and Herzegovina

Location

Polyclinic Dr. Al-Tawil

Sarajevo, Bosnia and Herzegovina

Location

Opca Bolnica Tesanj

Tešanj, Bosnia and Herzegovina

Location

Plava Medical Group

Tuzla, Bosnia and Herzegovina

Location

Cantonal Hospital Zenica

Zenica, Bosnia and Herzegovina

Location

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

Goiânia, Brazil

Location

Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

Porto Alegre, Brazil

Location

Ufrj - Hospital Universitario Clementino Fraga Filho

Rio de Janeiro, Brazil

Location

Praxis Pesquisa Medica

Santo André, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clinicos

São Bernardo do Campo, Brazil

Location

Kaiser Clinica

São José do Rio Preto, Brazil

Location

MUMC - Hamilton Health Sciences

Hamilton, Canada

Location

Installation Hospital Maisonneuve-Rosemont

Montreal, Canada

Location

Royal University Hospital

Saskatoon, Canada

Location

Opca bolnica Bjelovar

Bjelovar, Croatia

Location

Clinical Hospital Osijek

Osijek, Croatia

Location

Opca bolnica Pula

Pula, Croatia

Location

Zadar General Hospital

Zadar, Croatia

Location

Poliklinika Solmed

Zagreb, Croatia

Location

University Hospital Centre Zagreb

Zagreb, Croatia

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Hillerod Hospital

Hillerød, Denmark

Location

Lillebælt Hospital Vejle

Vejle, Denmark

Location

CHRU de Lille - Hôpital Claude Huriez

Lille, France

Location

CHRU Montpellier-Hopital Saint Eloi - Hepato-gastro-enterologie

Montpellier, France

Location

CHU de Nancy Brabois

Nancy, France

Location

CHU de Nice - Hôpital de l'Archet II - Gastro-Entérologie, Hépatologie

Nice, France

Location

Hopital Bichat - Gastroenterology

Paris, France

Location

Hopital Saint Antoine

Paris, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Location

CHU de Saint Etienne, Hôpital Nord - Service de Gastroentérologie

Saint-Etienne, France

Location

CHU Amiens - Hopital Sud - Service Hepato-Gastroenterolog

Salouël, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

Toulouse, France

Location

JSC " Evex Hospitals"

Batumi, Georgia

Location

LTD Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Charité - Universitätsmedizin Berlin KöR

Berlin, Germany

Location

University Hospital Cologne AöR

Cologne, Germany

Location

MVZ Sanaklinikum Duisburg

Duisburg, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt am Main, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität - Medizinische Klinik I

Frankfurt am Main, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Uniklinik Halle (Saale)

Halle, Germany

Location

Gastroenterology Outpatient Clinic Prof. Dr. med. Ehehalt

Heidelberg, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Germany

Location

Medius Klinik Nürtingen

Nürtingen, Germany

Location

Universitätsklinikum Rostock

Rostock, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Internistische Praxis Weyhe

Weyhe, Germany

Location

Clinexpert Egészségügyi Szolgáltató És Kereskedelmi Kft.

Budapest, Hungary

Location

Pannónia Magánorvosi Centrum Kft

Budapest, Hungary

Location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika

Budapest, Hungary

Location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, Hungary

Location

SzTE Szt-Gy A Orvostud Kar Bel Klin

Szeged, Hungary

Location

The Barzilai Medical Center

Ashkelon, Israel

Location

The Edith Wolfson Medical Center

Holon, Israel

Location

Hadassah Medical Organization, Hadassah Medical Center, Ein-

Jerusalem, Israel

Location

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Galilee Medical Center (Western Galilee Hospital)

Nahariya, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

ASST Papa Giovanni XXIII - Cardiologia - Bergamo

Bergamo, Italy

Location

AO Brotzu

Cagliari, Italy

Location

Universita degli Studi di Firenze - Azienda Ospedaliero - Un

Florence, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Azienda Ospedaliera San Gerardo

Monza, Italy

Location

AOU di Padova

Padua, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata (P

Roma, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Policlinico Universitario Campus Biomedico

Rome, Italy

Location

A.O. Ordine Mauriziano Di Torino

Torino, Italy

Location

AOU S. Maria della Misericordia

Udine, Italy

Location

Universita degli Studi dell'Insubria - Ospedale di Circolo e

Varese, Italy

Location

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, Lithuania

Location

Klaipeda Seamen's Hospital

Klaipėda, Lithuania

Location

Republic Klaipeda Hospital

Klaipėda, Lithuania

Location

Panevezio ligonine

Panevezys, Lithuania

Location

Vilniaus Universiteto ligonines Santariskiu Klinikos

Vilnius, Lithuania

Location

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

Durango, Mexico

Location

Clinicos Asociados Bocm, S.C.

Mexico City, Mexico

Location

Medical Care and Research S. A. de C. V

Mérida, Mexico

Location

Centro Regiomontano de Estudios Clinicos Roma SC

Monterrey, Mexico

Location

Clinical Research Institute S.C.

Tlalnepantla, Mexico

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Ålesund Hospital, Møre & Romsdal Hospital trust, Dept. of Medicine, div of Gastroenterology and the Clinical research unit HMR

Ålesund, Norway

Location

Akershus Universitetssykehus

Lørenskog, Norway

Location

Universitetssykehuset Nord-Norge Tromsø, Gastrolab, Medisinsk poliklinikk, B8

Tromsø, Norway

Location

Vestfold Hjertesenter As

Tønsberg, Norway

Location

MPS - MED sp. z o.o.

Grudziądz, Poland

Location

MZ Badania Slowik Zymla Spolka jawna

Knurów, Poland

Location

Centrum Medyczne Plejady

Krakow, Poland

Location

Centrum Medyczne PROMED

Krakow, Poland

Location

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Poland

Location

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi

Lodz, Poland

Location

Klinika Badawcza Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

Malbork, Poland

Location

Twoja Przychodnia - Opolskie Centrum Medyczne

Opole, Poland

Location

Medicome Sp. z o.o.

Oświęcim, Poland

Location

Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

Poznan, Poland

Location

ETG Skierniewice

Skierniewice, Poland

Location

KO-MED Centra Kliniczne Staszow

Staszów, Poland

Location

Twoja Przychodnia - SCM

Szczecin, Poland

Location

GASTROMED Kopoń, Zmudziński i Wspólnicy spółka jawna, Specjalistyczne Centrum Gastrologii i Endoskopii, Specjalistyczne Gabinety Lekarskie

Torun, Poland

Location

Bodyclinic sp. z o.o. sp.k.

Warsaw, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Poland

Location

Centrum Zdrowia Matki, Dziecka i Mlodziezy

Warsaw, Poland

Location

PlanetMed

Wroclaw, Poland

Location

ETG Zamosc

Zamość, Poland

Location

Hospital Prof. Doutor Fernando Fonseca (HFF) (Hospital Amadora Sintra)

Amadora, Portugal

Location

Hospital de Braga

Braga, Portugal

Location

Hospital Beatriz Angelo (HBA)

Loures, Portugal

Location

Centro Hospitalar de Entre o Douro e Vouga (CHEDV)- Hospital São Sebastião

Santa Maria da Feira, Portugal

Location

Sana Monitoring

Bucharest, Romania

Location

Spitalul Clinic Colentina

Bucharest, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, Romania

Location

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi

Iași, Romania

Location

Spitalul Clinic Judetean Mures

Târgu Mureş, Romania

Location

Cabinet Particular Policlinic Algomed

Timișoara, Romania

Location

Clinic Center of Serbia

Belgrade, Serbia

Location

Clinical Hospital Center "Dr. Dragisa Misovic"

Belgrade, Serbia

Location

Euromedik Hospital

Belgrade, Serbia

Location

Zvezdara University Medical Center

Belgrade, Serbia

Location

Clinical Center Kragujevac - Center for Gastroenterohepatology

Kragujevac, Serbia

Location

General Hospital Dr Djordje Joanovic

Zrenjanin, Serbia

Location

General hospital Zrenjanin

Zrenjanin, Serbia

Location

FNsP F.D.R. Banska Bystrica

Banská Bystrica, Slovakia

Location

CLINIQ s.r.o.

Bratislava, Slovakia

Location

ENDOMED s.r.o.

Košice, Slovakia

Location

GASTROMEDIC, s.r.o.

Nové Zámky, Slovakia

Location

Accout Center s.r.o.

Šahy, Slovakia

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Hanyang University Guri Hospital

Guri-si, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital - Internal Medicine

Soeul, South Korea

Location

Kyung Hee University Hospital

Soeul, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

Örebro Univ. Hospital

Örebro, Sweden

Location

Karolinska Universitetssjukhuset - Gastroenterology

Stockholm, Sweden

Location

Uppsala University Hospital, Akademiska

Uppsala, Sweden

Location

Hacettepe University Medical Faculty - Hematology

Ankara, Turkey (Türkiye)

Location

Istanbul University Medical Faculty

Istanbul, Turkey (Türkiye)

Location

Mersin Universtiy Medical Faculty

Mersin, Turkey (Türkiye)

Location

Northern Care Alliance NHS Foundation Trust-Fairfield General Hospital - Gastroenterology

Bury, United Kingdom

Location

Accellacare Warwickshire Quality Research Site

Coventry, United Kingdom

Location

County Durham and Darlington NHS Foundation Trust (CDDFT) - Darlington Memorial Hospital

Darlington, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

North West London Hospitals NHS Trust

Harrow, United Kingdom

Location

Central Middlesex Hospital

London, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Accellacare North London

Northwood, United Kingdom

Location

Accellacare Limited/Accellacare of South London

Orpington, United Kingdom

Location

Royal Berkshire Hospital

Reading, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Gastrointestinal Diseases; Inflammatory Bowel Diseases

Interventions

cobitolimod

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Raja Atreya, Professor

  Friedrich-Alexander University Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: November 24, 2021
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3); GB (10); GE (2); BR (6); PT (4); AU (4); IL (6); BE (6); HU (5); LI (5); FR (11); BO (8); SE (3); KR (10); ME (5); CA (3); SL (5); US (25); NL (1); IT (12); CR (6); DE (16); NO (4); PL (19); RO (6); DK (5)