Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Launched by ABBVIE · Aug 8, 2024
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring new targeted therapies to treat adults with moderate to severe Crohn's Disease, a long-lasting condition that causes inflammation in the digestive tract and can lead to symptoms like belly pain, diarrhea, and weight loss. The study will test three specific medications: risankizumab, ABBV-382, and lutikizumab. About 500 participants will be enrolled across 300 locations worldwide, and they will be randomly assigned to receive one of these treatments. Each participant will go through a 12-week initial treatment phase followed by another 12 weeks of ongoing care, with the possibility of continuing treatment afterward.
To be eligible for the trial, participants need to be at least 18 years old, weigh at least 40 kg, and have a confirmed diagnosis of Crohn's Disease for at least three months. They should also have had a poor response to previous treatments. Throughout the study, participants will attend regular visits to a hospital or clinic for medical assessments, blood tests, and check for any side effects. It's important to note that being part of this trial may involve more visits and treatments compared to standard care. This study aims to find effective new options for managing Crohn's Disease and improving patients' quality of life.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants' body weight must be ≥ 40 kg at Baseline.
- • Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.
- • CDAI ≥ 220 at Baseline.
- • Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.
- • Participants must demonstrate intolerance or inadequate response to TaTs including biologics
- Exclusion Criteria:
- • Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.
- • Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.
- • Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.
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
San Diego, California, United States
Inverness, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
Macon, Georgia, United States
New Bedford, Massachusetts, United States
Las Vegas, Nevada, United States
Yonkers, New York, United States
Asheville, North Carolina, United States
Tyler, Texas, United States
Dothan, Alabama, United States
Colorado Springs, Colorado, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Zephyrhills, Florida, United States
Liberty, Missouri, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Orangeburg, South Carolina, United States
Johnson City, Tennessee, United States
Ogden, Utah, United States
Salt Lake City, Utah, United States
Quebec, , Canada
Boise, Idaho, United States
Columbia, Missouri, United States
Mansfield, Texas, United States
Tacoma, Washington, United States
Southlake, Texas, United States
Springfield, Illinois, United States
Chevy Chase, Maryland, United States
Garland, Texas, United States
San Antonio, Texas, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cedar Park, Texas, United States
Mobile, Alabama, United States
Peoria, Illinois, United States
Calgary, Alberta, Canada
Durham, North Carolina, United States
Wels, Oberoesterreich, Austria
Lisboa, , Portugal
Guimaraes, Braga, Portugal
Braga, , Portugal
Coimbra, , Portugal
Lisboa, , Portugal
Viana Do Castelo, , Portugal
Seville, Sevilla, Spain
Barcelona, , Spain
Madrid, , Spain
Kiel, Schleswig Holstein, Germany
Berlin, , Germany
Haifa, , Israel
Torun, Kujawsko Pomorskie, Poland
Lubbock, Texas, United States
San Antonio, Texas, United States
Sofiya, Sofia, Bulgaria
Sofiya, Sofia, Bulgaria
Sofiya, Sofia, Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Leipzig, Sachsen, Germany
Sopot, Pomorskie, Poland
Varna, , Bulgaria
Budapest, , Hungary
Riga, , Latvia
Madrid, , Spain
Hradec Králové, Hradec Kralove, Czechia
Krakow, Malopolskie, Poland
Kielce, Swietokrzyskie, Poland
Prague, Praha 9, Czechia
Halle (Saale), Sachsen Anhalt, Germany
Cluj Napoca, Cluj, Romania
Košice, , Slovakia
Santiago De Compostela, , Spain
Salzburg, , Austria
Wien, , Austria
Plovdiv, , Bulgaria
Vaughan, Ontario, Canada
Berlin, , Germany
Bydgoszcz, Kujawsko Pomorskie, Poland
Mannheim, Baden Wuerttemberg, Germany
Timișoara, Timis, Romania
Belgrade, Beograd, Serbia
Coronado, California, United States
Danbury, Connecticut, United States
Zagreb, Grad Zagreb, Croatia
Osijek, Osjecko Baranjska Zupanija, Croatia
Rijeka, , Croatia
Dresden, Sachsen, Germany
Warszawa, Mazowieckie, Poland
Cluj Napoca, Cluj, Romania
Belgrade, Beograd, Serbia
Tampa, Florida, United States
El Paso, Texas, United States
Leskovac, Jablanicki Okrug, Serbia
Santiago De Compostela, A Coruna, Spain
Holon, Hamerkaz, Israel
Tel Aviv, Tel Aviv, Israel
Turin, Torino, Italy
Warsaw, Mazowieckie, Poland
Bucharest, Bucuresti, Romania
Bucharest, , Romania
Novi Sad, , Serbia
Pontevedra, , Spain
Brno, Jihomoravsky Kraj, Czechia
Kaunas, , Lithuania
Ulm, Baden Wuerttemberg, Germany
Saint Louis, Missouri, United States
Tallinn, Harjumaa, Estonia
Tallinn, Harjumaa, Estonia
St Priest En Jarez, Loire, France
Montpellier, , France
Homburg, Saarland, Germany
Ballinasloe, Galway, Ireland
Rome, Roma, Italy
Riga, , Latvia
Belgrade, Beograd, Serbia
Seville, Sevilla, Spain
Glasgow, Scotland, United Kingdom
London, , United Kingdom
Pierre Benite, Rhone, France
Paris, , France
Zrenjanin, Vojvodina, Serbia
Leuven, Vlaams Brabant, Belgium
Be'er Sheva, Hadarom, Israel
Dublin, , Ireland
Erlangen, Bayern, Germany
Berlin, , Germany
Szeged, , Hungary
Ljubljana, , Slovenia
Toulouse Cedex 9, Haute Garonne, France
Szekszárd, Tolna, Hungary
Negrar, Verona, Italy
Tilburg, Noord Brabant, Netherlands
Bern, , Switzerland
Lueneburg, Niedersachsen, Germany
Tychy, Slaskie, Poland
Nantes, , France
Rennes, , France
Freiburg, Baden Wuerttemberg, Germany
Utrecht, , Netherlands
Banska Bystrica, Banskobystricky Kraj, Slovakia
Margate, Florida, United States
Vandoeuvre Les Nancy, Lorraine, France
Lübeck, Schleswig Holstein, Germany
Drogheda, Louth, Ireland
Liège, Liege, Belgium
Lexington, Kentucky, United States
Philadelphia, Pennsylvania, United States
Split, Splitsko Dalmatinska Zupanija, Croatia
Tartu, , Estonia
Ludwigshafen Am Rhein, Rheinland Pfalz, Germany
Mullingar, Westmeath, Ireland
Liepaja, , Latvia
Panevezys, , Lithuania
Celje, , Slovenia
Barcelona, , Spain
Milan, Milano, Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Nitra, Nitriansky Kraj, Slovakia
Nice, Alpes Maritimes, France
Dublin, , Ireland
Daegu, , Korea, Republic Of
Vilnius, , Lithuania
Prešov, Presovsky Kraj, Slovakia
Nice, Alpes Maritimes, France
San Giovanni Rotondo, Foggia, Italy
Dongjak Gu, Gyeonggido, Korea, Republic Of
Messina, , Italy
Valencia, , Spain
Houston, Texas, United States
New York, New York, United States
Liege, , Belgium
Montpellier, Herault, France
Dongjak Gu, Seoul Teugbyeolsi, Korea, Republic Of
Busan, Busan Gwang Yeogsi, Korea, Republic Of
Yvoir, Namur, Belgium
Daejeon, Daejeon Gwang Yeogsi, Korea, Republic Of
Guildford, Surrey, United Kingdom
Edmonton, Alberta, Canada
Pessac Cedex, Gironde, France
Budapest, , Hungary
Rozzano, Lombardia, Italy
Busan, Busan Gwang Yeogsi, Korea, Republic Of
Newcastle Upon Tyne, , United Kingdom
Innsbruck, Tirol, Austria
London, Ontario, Canada
Dublin, , Ireland
Rome, Roma, Italy
Oxford, Oxfordshire, United Kingdom
Monserrato, Cagliari, Italy
Frankfurt Am Main, Hessen, Germany
Haifa, H Efa, Israel
Budapest, , Hungary
Woluwe Saint Lambert, Bruxelles Capitale, Belgium
Hershey, Pennsylvania, United States
Kortrijk, West Vlaanderen, Belgium
Sacramento, California, United States
New Haven, Connecticut, United States
Linz, , Austria
Bruxelles, Bruxelles Capitale, Belgium
Sofia, , Bulgaria
St Priest En Jarez, Loire, France
Catanzaro, , Italy
Great Neck, New York, United States
Alesund, More Og Romsdal, Norway
Glasgow, Glasgow City, United Kingdom
London, Greater London, United Kingdom
Brussels, Bruxelles Capitale, Belgium
Singapore, , Singapore
Bonheiden, Antwerpen, Belgium
Anderlecht, Bruxelles Capitale, Belgium
La Jolla, California, United States
Amsterdam, Noord Holland, Netherlands
Singapore, Central Singapore, Singapore
Singapore, Central Singapore, Singapore
Oslo, , Norway
Groningen, , Netherlands
Linz, Oberoesterreich, Austria
Bucharest, Bucuresti, Romania
Lørenskog, Akershus, Norway
Quebec, , Canada
Coventry, Warwickshire, United Kingdom
Frankfurt, Hessen, Germany
Edinburgh, , United Kingdom
Chicago, Illinois, United States
London, Greater London, United Kingdom
Graz, Steiermark, Austria
Prague, , Czechia
Edinburgh, , United Kingdom
Debrecen, Hajdu Bihar, Hungary
Budapest, , Hungary
Edinburgh, , United Kingdom
Novi, Michigan, United States
London, Greater London, United Kingdom
Rochester, Minnesota, United States
Varna, , Bulgaria
Milano, , Italy
Kaunas, , Lithuania
Kielce, Swietokrzyskie, Poland
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported