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
NCT ID: NCT05068284
Last Updated: 2024-10-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
176 participants
INTERVENTIONAL
2022-01-31
2023-07-20
Brief Summary
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ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide.
The study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. 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, checking for side effects and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Induction Phase: ABBV-154 Randomized Dose A
Varying doses of ABBV-154 as described in the protocol.
ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
Induction Phase: ABBV-154 Randomized Dose B
Varying doses of ABBV-154 as described in the protocol.
ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
Induction Phase: ABBV-154 Randomized Dose C
Varying doses of ABBV-154 as described in the protocol.
ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
Induction Phase: ABBV-154 Randomized Dose D
Varying doses of ABBV-154 as described in the protocol.
ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
Placebo
Subcutaneous Injection
Induction Phase: Randomized Placebo
Fixed dose placebo as described in the protocol.
Placebo
Intravenous (IV) infusion; Subcutaneous Injection
Re-Induction Phase: ABBV-154 Randomized Dose A
Varying doses of ABBV-154 as described in the protocol.
ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
Re-Induction Phase: ABBV-154 Randomized Dose B
Varying doses of ABBV-154 as described in the protocol.
ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
Maintenance Phase: ABBV-154 Randomized Dose A
Fixed dose ABBV-154 every other week.
ABBV-154
Subcutaneous Injection
Maintenance Phase: ABBV-154 Randomized Dose B
Fixed dose ABBV-154 every other week.
ABBV-154
Subcutaneous Injection
Maintenance Phase: Randomized Placebo
Fixed dose placebo every other week.
Placebo
Subcutaneous Injection
Interventions
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ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
Placebo
Intravenous (IV) infusion; Subcutaneous Injection
ABBV-154
Subcutaneous Injection
Placebo
Subcutaneous Injection
Eligibility Criteria
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Inclusion Criteria
* 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, ustekinumab, or risankizumab.
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Digestive Health Specialists of the Southeast /ID# 239599
Dothan, Alabama, United States
East View Medical Research, LLC /ID# 240030
Mobile, Alabama, United States
Southern California Res. Ctr. /ID# 233512
Coronado, California, United States
Hoag Memorial Hosp Presbyterian /ID# 233555
Irvine, California, United States
University of Colorado Hospital /ID# 239361
Aurora, Colorado, United States
Medical Research Center of CT /ID# 233542
Hamden, Connecticut, United States
Atlantic Medical Research /ID# 233506
Margate, Florida, United States
University of Miami /ID# 233811
Miami, Florida, United States
Gastroenterology Group Naples /ID# 233829
Naples, Florida, United States
Digestive Disease Consultants - Orange Park /ID# 241015
Orange Park, Florida, United States
Endoscopic Research, Inc. /ID# 234279
Orlando, Florida, United States
IMIC Inc. Medical Research /ID# 233821
Palmetto Bay, Florida, United States
Emory University /ID# 241014
Atlanta, Georgia, United States
AGILE Clinical Research Trials /ID# 233739
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 245604
Macon, Georgia, United States
GI Specialists of GA, PC /ID# 239261
Marietta, Georgia, United States
Gastroenterology Consultants, P.C /ID# 233552
Roswell, Georgia, United States
The University of Chicago DCAM /ID# 233824
Chicago, Illinois, United States
Digestive Health Services /ID# 241177
Downers Grove, Illinois, United States
Southwest Gastroenterology /ID# 234278
Oak Lawn, Illinois, United States
University of Louisville /ID# 233766
Louisville, Kentucky, United States
Louisiana Research Center, LLC /ID# 245370
Shreveport, Louisiana, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765
Ann Arbor, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763
Wyoming, Michigan, United States
Mayo Clinic - Rochester /ID# 238516
Rochester, Minnesota, United States
Las Vegas Medical Research /ID# 233826
Las Vegas, Nevada, United States
Allied Health Clinical Research Organization, LLC /ID# 241935
Englewood, New Jersey, United States
The Mount Sinai Hospital /ID# 233823
New York, New York, United States
Lenox Hill Hospital /ID# 239312
New York, New York, United States
New York Gastroenterology Associates /ID# 241967
New York, New York, United States
Univ NC Chapel Hill /ID# 233557
Chapel Hill, North Carolina, United States
Northshore Gastroentrology Research LLC /ID# 239307
Brooklyn, Ohio, United States
University of Cincinnati /ID# 234237
Cincinnati, Ohio, United States
Hightower Clinical /ID# 239598
Oklahoma City, Oklahoma, United States
Digestive Disease Specialists /ID# 233825
Oklahoma City, Oklahoma, United States
University of Pennsylvania /ID# 239291
Philadelphia, Pennsylvania, United States
Allegheny Health Network Research Institute /ID# 239334
Pittsburgh, Pennsylvania, United States
Gastroenterology Associates, P.A. of Greenville /ID# 233544
Greenville, South Carolina, United States
Gastro One /ID# 239748
Cordova, Tennessee, United States
Southern Star Research Institute, LLC /ID# 240132
San Antonio, Texas, United States
Tyler Research Institute, LLC /ID# 233730
Tyler, Texas, United States
Gastro Health & Nutrition - Victoria /ID# 240158
Victoria, Texas, United States
University of Utah Hospitals and Clinics /ID# 239264
Salt Lake City, Utah, United States
Gastro Health Research /ID# 240085
Fairfax, Virginia, United States
Hunter Holmes McGuire VA Medical Center /ID# 233759
Richmond, Virginia, United States
Concord Repatriation General /ID# 233467
Concord, New South Wales, Australia
Princess Alexandra Hospital /ID# 234243
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital /ID# 233705
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital /ID# 234242
Woodville South, South Australia, Australia
Monash Medical Centre /ID# 233469
Clayton, Victoria, Australia
Fiona Stanley Hospital /ID# 240136
Murdoch, Western Australia, Australia
Medizinische Universitaet Innsbruck /ID# 234217
Innsbruck, Tyrol, Austria
Medizinische Universitaet Wien /ID# 234218
Vienna, Vienna, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069
Salzburg, , Austria
UCL Saint-Luc /ID# 232435
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent /ID# 246877
Ghent, Oost-Vlaanderen, Belgium
AZ-Delta /ID# 232437
Roeselare, West-Vlaanderen, Belgium
AZ Maria Middelares /ID# 246880
Ghent, , Belgium
CHU de Liege /ID# 232436
Liège, , Belgium
UMHAT Kaspela /ID# 232468
Plovdiv, , Bulgaria
Second MHAT Sofia /ID# 250706
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 233522
Sofia, , Bulgaria
UMHAT Tsaritsa Joanna - ISUL /ID# 234135
Sofia, , Bulgaria
Acibadem City Clinic University Hospital EOOD /ID# 240003
Sofia, , Bulgaria
University of Calgary /ID# 233838
Calgary, Alberta, Canada
Gastroenterology and Internal Medicine Research Institution /ID# 233831
Edmonton, Alberta, Canada
QE II Health Sciences Centre /ID# 233839
Halifax, Nova Scotia, Canada
London Health Sciences Center- University Hospital /ID# 234058
London, Ontario, Canada
Scott Shulman Medicine Professional Corporation /ID# 239567
North Bay, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc /ID# 234142
North York, Ontario, Canada
Toronto Digestive Disease Associates, Inc. /ID# 234143
Vaughan, Ontario, Canada
Hepato-Gastroenterologie HK, s.r.o. /ID# 239965
Hradec Králové, , Czechia
ARTROSCAN s.r.o. /ID# 239882
Ostrava, , Czechia
Nemocnice Horovice - NH Hospital a.s /ID# 233915
Prague, , Czechia
Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486
Prague, , Czechia
CHU Montpellier - Hôpital Saint Eloi /ID# 241136
Montpellier, Herault, France
CHRU Nancy - Hopitaux de Brabois /ID# 234224
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 234225
Saint Priest EN Jarez, Pays de la Loire Region, France
AP-HP - Hopital Saint-Louis /ID# 234227
Paris, , France
Universitaetsklinikum Freiburg /ID# 233719
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitatsklinikum Mannheim /ID# 233716
Mannheim, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 233531
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen /ID# 233529
Erlangen, Bavaria, Germany
Universitatsklinik Regensburg /ID# 238702
Regensburg, Bavaria, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527
Kiel, Schleswig-Holstein, Germany
DRK Kliniken Berlin Westend /ID# 233718
Berlin, , Germany
Medizinische Hochschule Hannover /ID# 238804
Hanover, , Germany
EUGASTRO GmbH /ID# 233717
Leipzig, , Germany
Klinikum Lueneburg /ID# 233720
Lüneburg, , Germany
General Hospital of Athens Ippokratio /ID# 231655
Athens, Attica, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 231657
Heraklion, Crete, Greece
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 231659
Pireaus, , Greece
Clinfan Szolgaltato Kft. /ID# 249662
Szekszárd, , Hungary
Shaare Zedek Medical Center /ID# 233460
Jerusalem, Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 233518
Jerusalem, Jerusalem, Israel
The Edith Wolfson Medical Center /ID# 234042
Ashkelon, Southern District, Israel
Soroka University Medical Center /ID# 233458
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 233457
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 238525
Tel Aviv, Tel Aviv, Israel
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386
Rho, Milano, Italy
Policlinico Agostino Gemelli /ID# 233380
Rome, Roma, Italy
Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387
Bari, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382
Milan, , Italy
Aichi Medical University Hospital /ID# 238528
Nagakute-shi, Aichi-ken, Japan
Daido Clinic /ID# 239730
Nagoya, Aichi-ken, Japan
Nagoya University Hospital /ID# 238662
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 238368
Nagoya, Aichi-ken, Japan
Tsujinaka Hospital Kashiwanoha /ID# 239012
Kashiwa-shi, Chiba, Japan
Fukushima Medical University Hospital /ID# 239314
Fukushima, Fukushima, Japan
Gunma University Hospital /ID# 239913
Maebashi, Gunma, Japan
Hiroshima University Hospital /ID# 238947
Hiroshima, Hiroshima, Japan
Asahikawa City Hospital /ID# 248061
Asahikawa-shi, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 239201
Sapporo, Hokkaido, Japan
Sapporo IBD Clinic /ID# 239054
Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital /ID# 239049
Nishinomiya-shi, Hyōgo, Japan
Kanazawa University Hospital /ID# 239670
Kanazawa, Ishikawa-ken, Japan
Iwate Medical University Uchimaru Medical Center /ID# 238953
Morioka, Iwate, Japan
St. Marianna University Hospital /ID# 239167
Kawasaki-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 239918
Kyoto, Kyoto, Japan
Mie University Hospital /ID# 239758
Tsu, Mie-ken, Japan
Tohoku University Hospital /ID# 238476
Sendai, Miyagi, Japan
Okayama University Hospital /ID# 239757
Okayama, Okayama-ken, Japan
Osaka Metropolitan University Hospital /ID# 238638
Osaka, Osaka, Japan
Osaka University Hospital /ID# 240485
Suita-shi, Osaka, Japan
Hamamatsu University Hospital /ID# 238527
Hamamatsu, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 239759
Sunto-gun, Shizuoka, Japan
Tokyo Medical And Dental University Hospital /ID# 238950
Bunkyo-ku, Tokyo, Japan
Kyorin University Hospital /ID# 239609
Mitaka-shi, Tokyo, Japan
Tokyo Medical University Hospital /ID# 239668
Shinjuku-ku, Tokyo, Japan
Center hospital of the National Center for Global Health and Medicine /ID# 239792
Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 239760
Shinjuku-ku, Tokyo, Japan
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554
Shinjuku-ku, Tokyo, Japan
Yamagata University Hospital /ID# 239572
Yamagata, Yamagata, Japan
Radboud Universitair Medisch Centrum /ID# 241292
Nijmegen, Gelderland, Netherlands
Academisch Medisch Centrum /ID# 232123
Amsterdam, , Netherlands
Dunedin Hospital /ID# 238325
Otago, Otago, New Zealand
Wellington Regional Hospital /ID# 238326
Newtown, Wellington Region, New Zealand
Hutt Hospital /ID# 238327
Lower Hutt, , New Zealand
Planetmed Sp. z o.o. /ID# 238447
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus /ID# 233533
Warsaw, Masovian Voivodeship, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653
Warsaw, Masovian Voivodeship, Poland
Endoskopia Sp. z o.o. /ID# 249906
Sopot, Pomeranian Voivodeship, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047
Guimarães, Braga District, Portugal
2CA-Braga, Hospital de Braga /ID# 249049
Braga, , Portugal
Mindful Medical Research /ID# 249609
San Juan, , Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373
Banská Bystrica, , Slovakia
ENDOMED s.r.o. /ID# 241855
Košice, , Slovakia
KM Management, spol. s.r.o. /ID# 241849
Nitra, , Slovakia
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700
Daejeon, , South Korea
Asan Medical Center /ID# 233701
Seoul, , South Korea
Samsung Medical Center /ID# 233698
Seoul, , South Korea
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299
Ferrol, A Coruna, Spain
Hospital Santa Creu i Sant Pau /ID# 232301
Barcelona, , Spain
Hospital Universitario La Paz /ID# 232300
Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 234103
Valencia, , Spain
China Medical University Hospital /ID# 234132
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 234131
Taichung, , Taiwan
National Taiwan University Hospital /ID# 234134
Taipei, , Taiwan
Royal Devon University Healthcare NHS Foundation Trust /ID# 234194
Exeter, Devon, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 238960
Southampton, Hampshire, United Kingdom
Barts Health NHS Trust /ID# 234188
London, London, City of, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 234191
London, London, City of, United Kingdom
NHS Greater Glasgow and Clyde /ID# 234186
Glasgow, Scotland, United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 234193
Tooting, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-002869-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M20-371
Identifier Type: -
Identifier Source: org_study_id
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