A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.
Inclusion Criteria:
Exclusion Criteria:
abbvieclinicaltrials@abbvie.com844-663-3742
Sacramento, California 95817, United States
San Diego, California 92103, United States
Colorado Springs, Colorado 80907, United States
Danbury, Connecticut 06810, United States
Gainesville, Florida 32610, United States
Inverness, Florida 34452-4717, United States
Tampa, Florida 33613, United States
Macon, Georgia 31201, United States
Indianapolis, Indiana 46202, United States
Lexington, Kentucky 40536, United States
Chevy Chase, Maryland 20815, United States
Lake Success, New York 11042, United States
Asheville, North Carolina 28801, United States
Oklahoma City, Oklahoma 73112, United States
Hershey, Pennsylvania 17033, United States
Orangeburg, South Carolina 29118, United States
Johnson City, Tennessee 37604, United States
Garland, Texas 75044, United States
San Antonio, Texas 78212, United States
Southlake, Texas 76092, United States
Seattle, Washington 98101, United States
Linz, Upper Austria 4010, Austria
Salzburg, 5020, Austria
Anderlecht, Brussels Capital 1070, Belgium
Brussels, Brussels Capital 1200, Belgium
Yvoir, Namur 5530, Belgium
Sofiya, Sofia 1527, Bulgaria
Sofiya, Sofia 1632, Bulgaria
Sofiya, Sofia 1784, Bulgaria
Varna, 9009, Bulgaria
Edmonton, Alberta T5R 1W2, Canada
London, Ontario N6A 5A5, Canada
Grad Zagreb, City of Zagreb 10000, Croatia
Split, Split-Dalmatia County 21000, Croatia
Rennes, Ille-et-Vilaine 35033, France
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54511, France
Pessac, New Aquitaine 33604, France
St-Priest-en-Jarez, Pays de la Loire Region 42270, France
Pierre-Bénite, Rhone 69310, France
Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate 67067, Germany
Halle, Saxony-Anhalt 06108, Germany
Kiel, Schleswig-Holstein 24105, Germany
Lübeck, Schleswig-Holstein 23538, Germany
Holon, Central District 5822012, Israel
Monserrato, Cagliari 09042, Italy
San Giovanni Rotondo, Foggia 71013, Italy
Rome, Roma 00133, Italy
Rome, Roma 00168, Italy
Kaunas, 50161, Lithuania
Amsterdam, North Holland 1105 AZ, Netherlands
Lørenskog, Akershus 1478, Norway
Ålesund, Møre og Romsdal 6017, Norway
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-231, Poland
Guimarães, Braga District 4835-044, Portugal
Viana do Castelo, 4900-408, Portugal
Belgrade, Beograd 11000, Serbia
Banská Bystrica, Banská Bystrica Region 975 17, Slovakia
Busan, Busan Gwang Yeogsi 48108, South Korea
Daejeon, Daejeon Gwang Yeogsi 34943, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Dilovası, Kocaeli 41455, Turkey (Türkiye)
Edinburgh, Edinburgh, City of EH4 2XU, United Kingdom
London, Greater London SW17 0QT, United Kingdom
Coventry, Warwickshire CV2 2DX, United Kingdom
Wolverhampton, West Midlands WV10 0QP, United Kingdom
478-742-2600
+32 2 535 46 03
fedurco@endomed.sk+421 905 271 215
gregusova.studie@gmail.com+421 905 686 916
+41 31 632 59 00