A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease (AIM-CD)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, ABBV-154
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to Baseline of the Induction Period.
- Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction Period.
- Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component.
- Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, or ustekinumab.
Exclusion Criteria:
- Participants with prior intolerance to adalimumab.
Sites / Locations
- Digestive Health Specialists of the Southeast /ID# 239599
- East View Medical Research, LLC /ID# 240030
- Southern California Res. Ctr. /ID# 233512
- Hoag Memorial Hosp Presbyterian /ID# 233555
- University of Colorado Hospital /ID# 239361
- Medical Research Center of CT /ID# 233542
- Atlantic Medical Research Group /ID# 233506
- University of Miami /ID# 233811
- Gastroenterology Group Naples /ID# 233829
- Digestive Disease Consultants - Orange Park /ID# 241015
- Endoscopic Research, Inc. /ID# 234279
- IMIC Inc. Medical Research /ID# 233821
- Emory University /ID# 241014
- Agile Clinical Research Trials /ID# 233739
- Gastroenterology Associates of Central Georgia, LLC /ID# 245604
- GI Specialists of GA, PC /ID# 239261
- Gastroenterology Consultants PC - Roswell /ID# 233552
- The University of Chicago DCAM /ID# 233824
- Digestive Health Services /ID# 241177
- Southwest Gastroenterology /ID# 234278
- University of Louisville /ID# 233766
- Louisana Research Center, LLC /ID# 245370
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763
- Mayo Clinic - Rochester /ID# 238516
- Las Vegas Medical Research /ID# 233826
- Gastroenterology Group of Northern NJ - Englewood Division /ID# 241935
- The Mount Sinai Hospital /ID# 233823
- Lenox Hill Hospital /ID# 239312
- New York Gastroenterology Associates /ID# 241967
- Univ NC Chapel Hill /ID# 233557
- Northshore Gastroentrology Research LLC /ID# 239307
- University of Cincinnati /ID# 234237
- Hightower Clinical /ID# 239598
- Digestive Disease Specialists /ID# 233825
- University of Pennsylvania /ID# 239291
- Allegheny Health Network Research Institute /ID# 239334
- Gastroenterology Associates, P.A. of Greenville /ID# 233544
- Gastro One /ID# 239748
- Southern Star Research Institute, LLC /ID# 240132
- Tyler Research Institute, LLC /ID# 233730
- Gastro Health & Nutrition - Victoria /ID# 240158
- University of Utah Hospitals and Clinics /ID# 239264
- Gastro Health Research /ID# 240085
- Hunter Holmes McGuire VA Medical Center /ID# 233759
- Concord Repatriation General /ID# 233467
- Princess Alexandra Hospital /ID# 234243
- Royal Adelaide Hospital /ID# 233705
- The Queen Elizabeth Hospital /ID# 234242
- Monash Medical Centre /ID# 233469
- Fiona Stanley Hospital /ID# 240136
- Medizinische Universitaet Innsbruck /ID# 234217
- Medizinische Universitaet Wien /ID# 234218
- Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069
- UCL Saint-Luc /ID# 232435
- UZ Gent /ID# 246877
- AZ-Delta /ID# 232437
- AZ Maria Middelares /ID# 246880
- CHU de Liege /ID# 232436
- UMHAT Kaspela /ID# 232468
- Second MHAT Sofia /ID# 250706
- UMHAT Sveti Ivan Rilski /ID# 233522
- UMHAT Tsaritsa Joanna - ISUL /ID# 234135
- Acibadem City Clinic University Hospital EOOD /ID# 240003
- University of Calgary /ID# 233838
- Gastroenterology and Internal Medicine Research Institution /ID# 233831
- QE II Health Sciences Centre /ID# 233839
- London Health Sciences Center- University Hospital /ID# 234058
- Scott Shulman Medicine Professional Corporation /ID# 239567
- Toronto Immune and Digestive Health Institute Inc /ID# 234142
- Toronto Digestive Disease Asso /ID# 234143
- Hepato-Gastroenterologie HK, s.r.o. /ID# 239965
- ARTROSCAN s.r.o. /ID# 239882
- Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486
- Nemocnice Horovice - NH Hospital a.s /ID# 233915
- CHU Montpellier - Hôpital Saint Eloi /ID# 241136
- CHU de SAINT ETIENNE - Hopital Nord /ID# 234225
- CHRU Nancy - Hopitaux de Brabois /ID# 234224
- AP-HP - Hopital Saint-Louis /ID# 234227
- Universitaetsklinikum Freiburg /ID# 233719
- Universitatsklinikum Mannheim /ID# 233716
- Universitaetsklinikum Ulm /ID# 233531
- Universitaetsklinikum Erlangen /ID# 233529
- Universitatsklinik Regensburg /ID# 238702
- Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527
- DRK Kliniken Berlin Westend /ID# 233718
- Medizinische Hochschule Hannover /ID# 238804
- EUGASTRO GmbH /ID# 233717
- Klinikum Lueneburg /ID# 233720
- General Hospital of Athens Ippokratio /ID# 231655
- General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660
- University General Hospital of Heraklion PA.G.N.I /ID# 231657
- General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 231659
- Clinfan Szolgaltato Kft. /ID# 249662
- Soroka University Medical Center /ID# 233458
- The Chaim Sheba Medical Center /ID# 233457
- Tel Aviv Sourasky Medical Center /ID# 238525
- Hadassah Medical Center-Hebrew University /ID# 233518
- The Edith Wolfson Medical Center /ID# 234042
- Shaare Zedek Medical Center /ID# 233460
- Policlinico Agostino Gemelli /ID# 233380
- ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386
- Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382
- Aichi Medical University Hospital /ID# 238528
- Nagoya City University Hospital /ID# 238368
- Daido Clinic /ID# 239730
- Nagoya University Hospital /ID# 238662
- Tsujinaka Hospital Kashiwanoha /ID# 239012
- Fukushima Medical University Hospital /ID# 239314
- Gunma University Hospital /ID# 239913
- Hiroshima University Hospital /ID# 238947
- Asahikawa City Hospital /ID# 248061
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791
- Sapporo Medical University Hospital /ID# 239201
- Sapporo IBD Clinic /ID# 239054
- Hyogo Medical University Hospital /ID# 239049
- Kanazawa University Hospital /ID# 239670
- Iwate Medical University Uchimaru Medical Center /ID# 238953
- St. Marianna University Hospital /ID# 239167
- University Hospital Kyoto Prefectural University of Medicine /ID# 239918
- Mie University Hospital /ID# 239758
- Tohoku University Hospital /ID# 238476
- Okayama University Hospital /ID# 239757
- Osaka Metropolitan University Hospital /ID# 238638
- Osaka University Hospital /ID# 240485
- Hamamatsu University Hospital /ID# 238527
- NHO Shizuoka Medical Center /ID# 239759
- Tokyo Medical And Dental University Hospital /ID# 238950
- Kyorin University Hospital /ID# 239609
- Tokyo Medical University Hospital /ID# 239668
- Center Hospital of the National Center for Global Health and Medicine /ID# 239792
- Tokyo Women's Medical University Hospital /ID# 239760
- Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554
- Yamagata University Hospital /ID# 239572
- The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700
- Asan Medical Center /ID# 233701
- Samsung Medical Center /ID# 233698
- Radboud Universitair Medisch Centrum /ID# 241292
- Academisch Medisch Centrum /ID# 232123
- Wellington Regional Hospital /ID# 238326
- Hutt Hospital /ID# 238327
- Dunedin Hospital /ID# 238325
- Planetmed Sp. z o.o. /ID# 238447
- WIP Warsaw IBD Point Profesor Kierkus /ID# 233533
- Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653
- Endoskopia Sp. z o.o. /ID# 249906
- Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047
- CCA Braga - Hospital de Braga /ID# 249049
- Mindful Medical Research /ID# 249609
- Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373
- ENDOMED s.r.o. /ID# 241855
- KM Management, spol. s.r.o. /ID# 241849
- Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299
- Hospital Santa Creu i Sant Pau /ID# 232301
- Hospital Universitario La Paz /ID# 232300
- Hospital Clinico Universitario de Valencia /ID# 234103
- China Medical University Hospital /ID# 234132
- Taichung Veterans General Hospital /ID# 234131
- National Taiwan University Hospital /ID# 234134
- Royal Devon University Healthcare NHS Foundation Trust /ID# 234194
- University Hospital Southampton NHS Foundation Trust /ID# 238960
- Barts Health NHS Trust /ID# 234188
- Guys and St Thomas NHS Foundation Trust /ID# 234191
- NHS Greater Glasgow and Clyde /ID# 234186
- St George's University Hospitals NHS Foundation Trust /ID# 234193
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Induction Phase: ABBV-154 Randomized Dose A
Induction Phase: ABBV-154 Randomized Dose B
Induction Phase: ABBV-154 Randomized Dose C
Induction Phase: ABBV-154 Randomized Dose D
Induction Phase: Randomized Placebo
Re-Induction Phase: ABBV-154 Randomized Dose A
Re-Induction Phase: ABBV-154 Randomized Dose B
Maintenance Phase: ABBV-154 Randomized Dose A
Maintenance Phase: ABBV-154 Randomized Dose B
Maintenance Phase: Randomized Placebo
Varying doses of ABBV-154 as described in the protocol.
Varying doses of ABBV-154 as described in the protocol.
Varying doses of ABBV-154 as described in the protocol.
Varying doses of ABBV-154 as described in the protocol.
Fixed dose placebo as described in the protocol.
Varying doses of ABBV-154 as described in the protocol.
Varying doses of ABBV-154 as described in the protocol.
Fixed dose ABBV-154 every other week.
Fixed dose ABBV-154 every other week.
Fixed dose placebo every other week.