A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis
Launched by ABBVIE · Feb 6, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called lutikizumab for adults with active ulcerative colitis (UC), a condition that causes inflammation and bleeding in the large intestine. The goal is to see how safe and effective lutikizumab is compared to another treatment called adalimumab. About 200 adults will take part in this study at various locations worldwide. Participants will be divided into groups to receive either different doses of lutikizumab or adalimumab over a 12-week period, followed by additional treatment based on their response.
To be eligible for this trial, participants must have been diagnosed with ulcerative colitis for at least 90 days and show signs of active disease. They should also have previously not responded well to other common treatments. Throughout the study, participants will need to attend regular visits for check-ups, which will include medical assessments, blood tests, and questionnaires to monitor their health and any side effects. It's important to note that the treatment process in this trial may require more frequent visits and monitoring than standard care.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participant has had a diagnosis of Ulcerative Colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the investigator, must be available.
- • Active UC with a Modified Mayo Score (mMS) of 5 to 9 points and Mayo Endoscopic Subscore (ESS) of 2 to 3 (confirmed by central review).
- • Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunomodulators, and/or advanced therapies.
- Exclusion Criteria:
- • Current diagnosis of Crohn's Disease (CD) or inflammatory bowel disease-unclassified.
- • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
- • Prior inadequate response, intolerance or loss of response to adalimumab (including biosimilars). Note: Participant may be enrolled if he/she discontinued adalimumab for reasons other than those listed above (e.g., loss of insurance) or he/she has been exposed to other advanced therapies, including anti-TNFs other than adalimumab.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Margate, Florida, United States
Macon, Georgia, United States
Wyoming, Michigan, United States
Chula Vista, California, United States
Coral Gables, Florida, United States
Chesterfield, Michigan, United States
Lakeland, Florida, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Chesterfield, Michigan, United States
Roswell, Georgia, United States
Shreveport, Louisiana, United States
Lancaster, California, United States
Miami, Florida, United States
Fargo, North Dakota, United States
Milwaukee, Wisconsin, United States
Osaka Shi, Osaka, Japan
Huntington Beach, California, United States
San Antonio, Texas, United States
Kashiwa Shi, Chiba, Japan
Kagoshima Shi, Kagoshima, Japan
Charlotte, North Carolina, United States
Kobe Shi, Hyogo, Japan
Oklahoma City, Oklahoma, United States
Houston, Texas, United States
Gamagori Shi, Aichi, Japan
Miami, Florida, United States
Naples, Florida, United States
Decatur, Georgia, United States
Brooklyn, New York, United States
Vaughan, Ontario, Canada
Be'er Sheva, Hadarom, Israel
Zerifin, Hamerkaz, Israel
Ramat Gan, Tel Aviv, Israel
Tel Aviv, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Haifa, , Israel
Nagakute, Aichi, Japan
Fukushima Shi, Fukushima, Japan
Gifu Shi, Gifu, Japan
Ogaki Shi, Gifu, Japan
Kagoshima Shi, Kagoshima, Japan
Fujidera Shi, Osaka, Japan
Saga Shi, Saga, Japan
Saitama Shi, Saitama, Japan
Sunto Gun, Shizuoka, Japan
Bunkyo Ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Hamilton, Waikato, New Zealand
Johannesburg, Gauteng, South Africa
Bern, , Switzerland
Taipei City, Taipei, Taiwan
Coronado, California, United States
Garland, Texas, United States
Osijek, Osjecko Baranjska Zupanija, Croatia
Hsinchu City, , Taiwan
Bayamon, , Puerto Rico
Woodville South, South Australia, Australia
Hamamatsu Shi, Shizuoka, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Fukuyama Shi, Hiroshima, Japan
Taichung, , Taiwan
Gainesville, Florida, United States
Indianapolis, Indiana, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Huntington, West Virginia, United States
Gent, Oost Vlaanderen, Belgium
Gent, , Belgium
Split, Splitsko Dalmatinska Zupanija, Croatia
Grad Zagreb, , Croatia
Rijeka, , Croatia
Parnu, , Estonia
Tallinn, , Estonia
Nantes, Pays De La Loire, France
Szekszárd, Tolna, Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Kitakyushu, Fukuoka, Japan
Nishinomiya Shi, Hyogo, Japan
Hachioji Shi, Tokyo, Japan
Toyama Shi, Toyama, Japan
Busan, Busan Gwang Yeogsi, Korea, Republic Of
Busan, Gyeongsangnamdo, Korea, Republic Of
Riga, , Latvia
Lower Hutt, Manawatu Wanganui, New Zealand
Lublin, Lubelskie, Poland
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Pomoravski Okrug, Serbia
Leskovac, Pomoravski Okrug, Serbia
Novi Sad, , Serbia
Cape Town, Western Cape, South Africa
Taoyuan City, , Taiwan
London, , United Kingdom
Houston, Texas, United States
Madrid, , Spain
Tychy, Slaskie, Poland
Tampa, Florida, United States
Kansas City, Kansas, United States
Liège, Liege, Belgium
Webster, Texas, United States
Panevezys, , Lithuania
Ljubljana, , Slovenia
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Anderlecht, Bruxelles Capitale, Belgium
Leuven, Vlaams Brabant, Belgium
Varna, Smolyan, Bulgaria
Sofiya, Sofia, Bulgaria
Tartu, , Estonia
Ulm, Baden Wuerttemberg, Germany
Szeged, , Hungary
Urayasu Shi, Chiba, Japan
Seoul, , Korea, Republic Of
Daugavpils, , Latvia
Kaunas, , Lithuania
Celje, , Slovenia
Pretoria, Gauteng, South Africa
Cape Town Milnerton, Western Cape, South Africa
Cambridge, Cambridgeshire, United Kingdom
Glasgow, Scotland, United Kingdom
Orange, California, United States
Sofiya, Sofia, Bulgaria
Leipzig, Sachsen, Germany
Kiel, Schleswig Holstein, Germany
Bunkyo Ku, Tokyo, Japan
Szczecin, Zachodniopomorskie, Poland
Santiago De Compostela, A Coruna, Spain
Sevilla, , Spain
Varna, , Bulgaria
Vaughan, Ontario, Canada
Tallinn, Harjumaa, Estonia
Lower Hutt, Wellington, New Zealand
Belgrade, Beograd, Serbia
Leskovac, Jablanicki Okrug, Serbia
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Pamplona, Navarra, Spain
Oxford, Oxfordshire, United Kingdom
Ksawerow, Lodzkie, Poland
Ludwigshafen Am Rhein, Rheinland Pfalz, Germany
Fitzroy Melbourne, Victoria, Australia
Sint Niklaas, Oost Vlaanderen, Belgium
Sofiya, Sofia, Bulgaria
Sofia, , Bulgaria
Hamburg, , Germany
Lake Success, New York, United States
Murdoch, Western Australia, Australia
Torun, Kujawsko Pomorskie, Poland
Nordbyhagen, Akershus, Norway
Munich, , Germany
Wrocław, Dolnoslaskie, Poland
Chojnice, Pomorskie, Poland
San Juan, , Puerto Rico
Aurora, Colorado, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Rochester, Minnesota, United States
Bankstown, New South Wales, Australia
Elizabeth Vale, South Australia, Australia
Sankt Poelten, Niederoesterreich, Austria
Plovdiv, , Bulgaria
Zagreb, Grad Zagreb, Croatia
Nice, Alpes Maritimes, France
Toulouse, Haute Garonne, France
St Priest En Jarez, Loire, France
Athens, Attiki, Greece
Heraklion, Kriti, Greece
Athens, , Greece
Thessaloniki, , Greece
Elm Park, Dublin, Ireland
Dublin, , Ireland
Negrar, Verona, Italy
Mitaka, , Japan
Daejeon, Daejeon Gwang Yeogsi, Korea, Republic Of
Liepaja, , Latvia
Panevezys, , Lithuania
Vilnius, , Lithuania
Otago, , New Zealand
Tromsø, Troms, Norway
San Juan, , Puerto Rico
Murska Sobota, , Slovenia
Santiago De Compostela, A Coruna, Spain
Bern, , Switzerland
London, Greater London, United Kingdom
Petah Tikva, , Israel
Hamamatsu, Shizuoka, Japan
Mitaka City, Tokyo, Japan
Mitaka Shi, Tokyo, Japan
Creteil, Paris, France
Nice, Alpes Maritimes, France
Mitaka Shi, Tokyo, Japan
Monserrato, Cagliari, Italy
Busan, Busan Gwang Yeogsi, Korea, Republic Of
Miami, Florida, United States
Zagreb, Grad Zagreb, Croatia
Tallinn, Harjumaa, Estonia
Edmonton, Alberta, Canada
Rome, Roma, Italy
St Priest En Jarez, Loire, France
Rome, Roma, Italy
Glasgow, Glasgow City, United Kingdom
New York, New York, United States
Edmonton, Alberta, Canada
London, Greater London, United Kingdom
Chicago, Illinois, United States
Winston Salem, North Carolina, United States
Fukuyama Shi, Hiroshima, Japan
Boston, Massachusetts, United States
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported