A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
Launched by ELI LILLY AND COMPANY · Sep 13, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two medications, eltrekibart and mirikizumab, to see how safe and effective they are for adults with moderately to severely active ulcerative colitis (UC). Ulcerative colitis is a condition that causes inflammation in the intestines, leading to symptoms like abdominal pain and diarrhea. The study is currently recruiting participants who have had UC for at least three months and haven't responded well to other treatments, such as steroids or advanced therapies.
To be eligible for the trial, participants need to have a confirmed diagnosis of UC and have experienced inadequate relief from their current medications. They should also be stable on certain oral UC treatments. The trial is open to all adults, and participants can expect to be closely monitored throughout the study to assess how well the medications work and to ensure their safety. It's important to note that individuals with certain other health issues or recent surgeries may not qualify for this study.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have had an established diagnosis of UC of ≥3 months in duration before baseline.
- • Have moderately to severely active UC as assessed by the UC disease activity score.
- • Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
- • Are on a stable dose of certain oral UC medications (including corticosteroids).
- • Must meet contraception requirements.
- Exclusion Criteria:
- • Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
- • Have experienced a thrombotic event within 24 weeks before baseline.
- • Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
- • Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
- • Have a history of certain adenomas, dysplasia's, or malignancies.
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Houston, Texas, United States
Montreal, Quebec, Canada
Madrid, , Spain
Chapel Hill, North Carolina, United States
Morioka, Iwate, Japan
Budapest, , Hungary
Nishinomiya, Hyogo, Japan
Bucharest, , Romania
Ulm, , Germany
Toyama, , Japan
Sevilla, , Spain
London, Ontario, Canada
Metairie, Louisiana, United States
Mitaka, Tokyo, Japan
Tsu, Mie, Japan
Ulm, Baden Württemberg, Germany
München, Bayern, Germany
Hannover, Niedersachsen, Germany
Kiel, Schleswig Holstein, Germany
Berlin, , Germany
Seoul, , Korea, Republic Of
Santiago De Compostela, , Spain
Pavia, , Italy
Milano, , Italy
Chiba, , Japan
Ioannina, , Greece
Isehara, Kanagawa, Japan
La Louviere, , Belgium
Wyoming, Michigan, United States
Sapporo, Hokkaido, Japan
Athens, , Greece
Belgrade, , Serbia
San Antonio, Texas, United States
Chikushino, Fukuoka, Japan
Novi Sad, , Serbia
Kanazawa, Ishikawa, Japan
Shinagawa Ku, Tokyo, Japan
Sopot, , Poland
Kofu, Yamanashi, Japan
Santiago De Compostela, A Coruña, Spain
Hiroshima Shi, Hiroshima, Japan
Chapel Hill, North Carolina, United States
Seoul, , Korea, Republic Of
Grenoble, , France
Szeged, Csongrád, Hungary
San M. De Tucuman, Tucumán, Argentina
Liepaja, , Latvia
Seoul, , Korea, Republic Of
Busan, , Korea, Republic Of
San Giovanni Rotondo, Fg, Italy
Sunto Gun, Shizuoka, Japan
Rosario, Santa Fe, Argentina
Suwon Si, Gyeonggi Do, Korea, Republic Of
Timisoara, , Romania
Wroclaw, , Poland
Rijeka, , Croatia
Yvoir, , Belgium
Baytown, Texas, United States
Rouen, , France
Szeged, , Hungary
Huelva, , Spain
Nice Cedex 3, , France
Kashiwa, Chiba, Japan
San Donato Milanese, Milano, Italy
Lancaster, California, United States
Ciudad Autonoma De Buenos Air, Buenos Aires, Argentina
Pierre Benite Cedex, Rhone, France
Koto Ku, Tokyo, Japan
Minato Ku, Tokyo, Japan
Daegu, , Korea, Republic Of
Cordoba, , Spain
Dublin, , Ireland
Hirosaki, Aomori, Japan
Bucuresti, , Romania
Belgrade, Beograd, Serbia
Zrenjanin, Vojvodina, Serbia
Halle (Saale), Sachsen Anhalt, Germany
Budapest, , Hungary
Krakow, , Poland
Tyler, Texas, United States
Coronado, California, United States
Monserrato, Cagliari, Italy
Belgrade, , Serbia
Brooklyn, New York, United States
Athens, Attikí, Greece
Caba, Ciudad Autónoma De Buenos Aire, Argentina
Valencia, , Spain
Padova, , Italy
Colorado Springs, Colorado, United States
Miami, Florida, United States
Pancevo, , Serbia
Grenoble, , France
Belgrade, , Serbia
Quilmes, Buenos Aires, Argentina
Kobenhavn Nv, , Denmark
Bologna, Bo, Italy
Gyongyos, Heves, Hungary
Riga, , Latvia
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Athens, Attikí, Greece
Kurume Shi, Fukuoka Ken, Japan
Gangwon Do, Kangwon Do, Korea, Republic Of
Hamburg, , Germany
Torun, , Poland
Tampa, Florida, United States
Tampa, Florida, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Rome, Roma, Italy
Montreal, Quebec, Canada
Las Palmas De Gc, Las Palmas, Spain
Krakow, , Poland
Wadowice, , Poland
Athens, Attikí, Greece
Lodz, , Poland
Opole, , Poland
İzmir, , Turkey
Zagreb, Grad Zagreb, Croatia
Warsaw, Mazowieckie, Poland
Munro, Buenos Aires, Argentina
Athens, , Greece
Lublin, , Poland
Los Alamitos, California, United States
Orange, California, United States
Rancho Cucamonga, California, United States
Hamden, Connecticut, United States
Orange Park, Florida, United States
Jackson Heights, New York, United States
New York, New York, United States
Houston, Texas, United States
Ogden, Utah, United States
Ogden, Utah, United States
Slany, , Czechia
Coronado, California, United States
Orlando, Florida, United States
Oak Lawn, Illinois, United States
Seattle, Washington, United States
Koriyama Shi, Fukushima, Japan
Sapporo, Hokkaido, Japan
Sumida Ku, , Japan
Poznan, , Poland
Tampa, Florida, United States
Edinburg, Texas, United States
Yokohama, Kanagawa, Japan
Oita City, Oita Ken, Japan
Fukuoak, , Japan
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Ciudad Real, , Spain
Hachinohe Shi, Aomori, Japan
Isesaki Shi, Gumma, Japan
Hiroshima City, Hiroshima, Japan
Sapporo Shi Chuo Ku, Hokkaido, Japan
Nara Shi, Nara, Japan
Osaka Shi, Osaka, Japan
Little Rock, Arkansas, United States
Osijek, , Croatia
Brno, , Czechia
Augsburg, Bayern, Germany
Brandenburg An Der Havel, Brandenburg, Germany
Frankfurt Am Main, Hessen, Germany
Budapest, , Hungary
Szekesfehervar, , Hungary
Kitakyushu Shi, Fukuoka, Japan
Shinjuku Ku, , Japan
Kagoshima City, Kagoshima, Japan
Bydgoszcz, , Poland
Bydgoszcz, , Poland
Krakow, , Poland
Wroclaw, , Poland
łódź, , Poland
Cluj Napoca, Cluj, Romania
Ploiesti, Prahova, Romania
Bucharest, , Romania
Bjelovar, , Croatia
Zlín, , Czechia
La Roche Sur Yon Cedex 9, , France
Heraklion, Crete, Greece
Segrate, Milano, Italy
Fano, Pu, Italy
Gazzi Messina, , Italy
Modena, , Italy
Roma, , Italy
Torino, , Italy
Wroclaw, Dolnośląskie, Poland
Beograd, , Serbia
Ankara, , Turkey
Malatya, , Turkey
Mersin, , Turkey
Wroclaw, , Poland
Caba, , Argentina
Brno, Czech Republic, Czechia
San M. De Tucuman, , Argentina
Athens, , Greece
Bogotá, , Colombia
Shinjuku Ku, , Japan
Medellin, Antioquia, Colombia
Cali, Valle Del Cauca, Colombia
Slavonski Brod, , Croatia
Roma, Rome, Italy
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported