The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
Launched by INDEX PHARMACEUTICALS · Jul 30, 2021
Trial Information
Current as of July 21, 2025
Terminated
Keywords
ClinConnect Summary
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.
Gender
ALL
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.
About Index Pharmaceuticals
Index Pharmaceuticals is a forward-thinking clinical trial sponsor dedicated to advancing innovative therapies across various therapeutic areas. Committed to improving patient outcomes, the organization specializes in the development and management of clinical trials, leveraging cutting-edge research methodologies and a patient-centric approach. With a focus on collaboration and regulatory compliance, Index Pharmaceuticals strives to accelerate the drug development process, ensuring that promising treatments reach the market in a timely manner while maintaining the highest standards of safety and efficacy. Through its experienced team and strategic partnerships, the company aims to address unmet medical needs and contribute to the evolution of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wien, , Austria
Rehovot, , Israel
Milwaukee, Wisconsin, United States
Woolloongabba, , Australia
Glasgow, , United Kingdom
Zagreb, , Croatia
Brussels, , Belgium
Greenville, North Carolina, United States
Jerusalem, , Israel
Poitiers, , France
Melbourne, , Australia
High Point, North Carolina, United States
Seoul, , Korea, Republic Of
Daegu, , Korea, Republic Of
Aalborg, , Denmark
Ulm, , Germany
Freiburg, , Germany
Monza, , Italy
Gent, , Belgium
New York, New York, United States
Nijmegen, , Netherlands
London, , United Kingdom
Bonheiden, , Belgium
Klaipeda, , Lithuania
Istanbul, , Turkey
Rostock, , Germany
Naples, Florida, United States
Osijek, , Croatia
Herlev, , Denmark
Reading, , United Kingdom
Seoul, , Korea, Republic Of
Kiel, , Germany
Fairfax, Virginia, United States
Mannheim, , Germany
Seoul, , Korea, Republic Of
Parkville, , Australia
Lille, , France
Erlangen, , Germany
Busan, , Korea, Republic Of
Topeka, Kansas, United States
Braga, , Portugal
Roma, , Italy
Beavercreek, Ohio, United States
Klagenfurt, , Austria
Roeselare, , Belgium
Antwerpen, , Belgium
Aarhus, Jutland, Denmark
Oswiecim, , Poland
Kaunas, , Lithuania
Lørenskog, , Norway
Cluj Napoca, , Romania
Manchester, , United Kingdom
Kraków, , Poland
Budapest, , Hungary
Warsaw, , Poland
Augsburg, , Germany
Paris Cedex 12, , France
Suwon Si, , Korea, Republic Of
Krakow, , Poland
Saskatoon, , Canada
Clayton, , Australia
Durango, , Mexico
Pierre Benite Cedex, , France
Guri Si, , Korea, Republic Of
Milan, , Italy
London, , United Kingdom
Skierniewice, , Poland
Bratislava, , Slovakia
Rancho Cucamonga, California, United States
Krakow, , Poland
Zamosc, , Poland
Fitzroy, , Australia
Boynton Beach, Florida, United States
Granada Hills, California, United States
Troy, Michigan, United States
Mission Viejo, California, United States
Salzburg, , Austria
Kortrijk, , Belgium
Sarajevo, , Bosnia And Herzegovina
Hillerød, , Denmark
Nancy, , France
Batumi, , Georgia
Soeul, , Korea, Democratic People's Republic Of
Vilnius, , Lithuania
Tønsberg, , Norway
Timişoara, , Romania
Belgrad, , Serbia
Košice, , Slovakia
Uppsala, , Sweden
Mersin, , Turkey
Tarzana, California, United States
Doral, Florida, United States
Nürtingen, , Germany
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Charlotte, North Carolina, United States
Carrollton, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
South Brisbane, , Australia
Innsbruck, , Austria
Banja Luka, , Bosnia And Herzegovina
Foca, , Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Tesanj, , Bosnia And Herzegovina
Tuzla, , Bosnia And Herzegovina
Zenica, , Bosnia And Herzegovina
Goiania, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Santo Andre, , Brazil
Sao Jose Do Rio Preto, , Brazil
São Bernardo Do Campo, , Brazil
Hamilton, , Canada
Montréal, , Canada
Bjelovar, , Croatia
Pula, , Croatia
Zadar, , Croatia
Zagreb, , Croatia
Vejle, , Denmark
Montpellier, , France
Nice, , France
Paris, , France
Saint étienne, , France
Salouel, , France
Toulouse, , France
Tiflis, , Georgia
Berlin, , Germany
Cologne, , Germany
Duisburg, , Germany
Frankfurt Am Main, , Germany
Frankfurt Am Main, , Germany
Halle, , Germany
Heidelberg, , Germany
Weyhe, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Szeged, , Hungary
Ashkelon, , Israel
H̱olon, , Israel
Jerusalem, , Israel
Nahariya, , Israel
Bergamo, , Italy
Cagliari, , Italy
Firenze, , Italy
Padova, , Italy
Roma, , Italy
Rom, , Italy
Torino, , Italy
Udine, , Italy
Varese, , Italy
Soeul, , Korea, Republic Of
Soeul, , Korea, Republic Of
Wŏnju, , Korea, Republic Of
Klaipeda, , Lithuania
Panevezys, , Lithuania
Merida, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Tlalnepantla, , Mexico
Tromsø, , Norway
ålesund, , Norway
Grudziadz, , Poland
Knurow, , Poland
Lodz, , Poland
Malbork, , Poland
Opole, , Poland
Poznan, , Poland
Staszow, , Poland
Szczecin, , Poland
Torun, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Amadora, , Portugal
Loures, , Portugal
Santa Maria Da Feira, , Portugal
Bucharest, , Romania
Bucuresti, , Romania
Iasi, , Romania
Târgu Mureș, , Romania
Belgrade, , Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Zrenjanin, , Serbia
Zrenjanin, , Serbia
Banska Bystrica, , Slovakia
Nove Zamky, , Slovakia
Sahy, , Slovakia
Stockholm, , Sweden
örebro, , Sweden
Ankara, , Turkey
Bury, , United Kingdom
Coventry, , United Kingdom
Darlington, , United Kingdom
Harrow, , United Kingdom
Northwood, , United Kingdom
Orpington, , United Kingdom
Patients applied
Trial Officials
Raja Atreya, Professor
Principal Investigator
Friedrich-Alexander University Erlangen-Nuremberg
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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