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
- Registration Number
- NCT05068284
- Lead Sponsor
- AbbVie
- Brief Summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 176
- 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, ustekinumab, or risankizumab.
- Participants with prior intolerance to adalimumab.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Induction Phase: ABBV-154 Randomized Dose D Placebo Varying doses of ABBV-154 as described in the protocol. Induction Phase: Randomized Placebo Placebo Fixed dose placebo as described in the protocol. Maintenance Phase: Randomized Placebo Placebo Fixed dose placebo every other week. Induction Phase: ABBV-154 Randomized Dose B ABBV-154 Varying doses of ABBV-154 as described in the protocol. Induction Phase: ABBV-154 Randomized Dose C ABBV-154 Varying doses of ABBV-154 as described in the protocol. Induction Phase: ABBV-154 Randomized Dose D ABBV-154 Varying doses of ABBV-154 as described in the protocol. Re-Induction Phase: ABBV-154 Randomized Dose B ABBV-154 Varying doses of ABBV-154 as described in the protocol. Maintenance Phase: ABBV-154 Randomized Dose A ABBV-154 Fixed dose ABBV-154 every other week. Maintenance Phase: ABBV-154 Randomized Dose B ABBV-154 Fixed dose ABBV-154 every other week. Induction Phase: ABBV-154 Randomized Dose A ABBV-154 Varying doses of ABBV-154 as described in the protocol. Re-Induction Phase: ABBV-154 Randomized Dose A ABBV-154 Varying doses of ABBV-154 as described in the protocol.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD) Baseline to Week 12 The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 (worst) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI) Induction Period Week 12 The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI \< 150.
Percentage of Participants Achieving Clinical Remission Per Average Daily Liquid or Very Soft Stool Frequency (SF) and Average Daily Abdominal Pain (AP) Score (SF/AP) Induction Period Week 12 Clinical remission is defined as average daily liquid or very soft stool SF \<= 2.8 and not worse than Baseline and average daily AP score \<= 1 and not worse than Baseline.
Percentage of Participants Achieving Endoscopic Response Per SES-CD Week 40 in the Maintenance Period The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Percentage of Participants Achieving Clinical Remission Per CDAI Week 40 in the Maintenance Period The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI \< 150.
Percentage of Participants Achieving Clinical Remission Per SF/AP Week 40 in the Maintenance Period Clinical remission is defined as average daily liquid or very soft SF \<= 2.8 and not worse than Baseline and average daily AP score \<= 1 and not worse than Baseline.
Trial Locations
- Locations (166)
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
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
Gastroenterology Associates of Central Georgia, LLC /ID# 245604
🇺🇸Macon, Georgia, United States
GI Specialists of GA, PC /ID# 239261
🇺🇸Marietta, Georgia, United States
Southwest Gastroenterology /ID# 234278
🇺🇸Oak Lawn, Illinois, United States
The University of Chicago DCAM /ID# 233824
🇺🇸Chicago, Illinois, United States
Digestive Health Services /ID# 241177
🇺🇸Downers Grove, Illinois, United States
University of Louisville /ID# 233766
🇺🇸Louisville, Kentucky, 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
The Mount Sinai Hospital /ID# 233823
🇺🇸New York, New York, United States
Lenox Hill Hospital /ID# 239312
🇺🇸New York, New York, United States
Univ NC Chapel Hill /ID# 233557
🇺🇸Chapel Hill, North Carolina, United States
New York Gastroenterology Associates /ID# 241967
🇺🇸New York, New York, 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, Tirol, Austria
Medizinische Universitaet Wien /ID# 234218
🇦🇹Vienna, Wien, Austria
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069
🇦🇹Salzburg, Austria
UCL Saint-Luc /ID# 232435
🇧🇪Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
UZ Gent /ID# 246877
🇧🇪Gent, Oost-Vlaanderen, Belgium
AZ-Delta /ID# 232437
🇧🇪Roeselare, West-Vlaanderen, Belgium
AZ Maria Middelares /ID# 246880
🇧🇪Gent, Belgium
CHU de Liege /ID# 232436
🇧🇪Liege, 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
Hepato-Gastroenterologie HK, s.r.o. /ID# 239965
🇨🇿Hradec Kralove, Czechia
ARTROSCAN s.r.o. /ID# 239882
🇨🇿Ostrava, Czechia
Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486
🇨🇿Prague 6, Czechia
Nemocnice Horovice - NH Hospital a.s /ID# 233915
🇨🇿Praha, Czechia
CHU Montpellier - Hôpital Saint Eloi /ID# 241136
🇫🇷Montpellier Cedex 5, Herault, France
CHU de SAINT ETIENNE - Hopital Nord /ID# 234225
🇫🇷St. Priest En Jarez, Loire, France
CHRU Nancy - Hopitaux de Brabois /ID# 234224
🇫🇷Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France
AP-HP - Hopital Saint-Louis /ID# 234227
🇫🇷Paris, France
Universitaetsklinikum Freiburg /ID# 233719
🇩🇪Freiburg, Baden-Wuerttemberg, Germany
Universitatsklinikum Mannheim /ID# 233716
🇩🇪Mannheim, Baden-Wuerttemberg, Germany
Universitaetsklinikum Ulm /ID# 233531
🇩🇪Ulm, Baden-Wuerttemberg, Germany
Universitaetsklinikum Erlangen /ID# 233529
🇩🇪Erlangen, Bayern, Germany
Universitatsklinik Regensburg /ID# 238702
🇩🇪Ratisbon, Bayern, 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
🇩🇪Hannover, Germany
EUGASTRO GmbH /ID# 233717
🇩🇪Leipzig, Germany
Klinikum Lueneburg /ID# 233720
🇩🇪Lueneburg, Germany
General Hospital of Athens Ippokratio /ID# 231655
🇬🇷Athens, Attiki, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660
🇬🇷Athens, Attiki, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 231657
🇬🇷Heraklion, Kriti, Greece
Clinfan Szolgaltato Kft. /ID# 249662
ðŸ‡ðŸ‡ºSzekszard, Hungary
The Edith Wolfson Medical Center /ID# 234042
🇮🇱Ashkelon, HaDarom, Israel
Tel Aviv Sourasky Medical Center /ID# 238525
🇮🇱Tel Aviv, Tel-Aviv, Israel
Soroka University Medical Center /ID# 233458
🇮🇱Be'er Sheva, HaDarom, Israel
The Chaim Sheba Medical Center /ID# 233457
🇮🇱Ramat Gan, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 233460
🇮🇱Jerusalem, Yerushalayim, Israel
Hadassah Medical Center-Hebrew University /ID# 233518
🇮🇱Jerusalem, Yerushalayim, 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, Japan
Nagoya City University Hospital /ID# 238368
🇯🇵Nagoya shi, Aichi, Japan
Daido Clinic /ID# 239730
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya University Hospital /ID# 238662
🇯🇵Nagoya-shi, Aichi, Japan
Tsujinaka Hospital Kashiwanoha /ID# 239012
🇯🇵Kashiwa-shi, Chiba, Japan
Fukushima Medical University Hospital /ID# 239314
🇯🇵Fukushima-shi, Fukushima, Japan
Gunma University Hospital /ID# 239913
🇯🇵Maebashi-shi, Gunma, Japan
Hiroshima University Hospital /ID# 238947
🇯🇵Hiroshima-shi, Hiroshima, Japan
Asahikawa City Hospital /ID# 248061
🇯🇵Asahikawa-shi, Hokkaido, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791
🇯🇵Sapporo-shi, Hokkaido, Japan
Sapporo Medical University Hospital /ID# 239201
🇯🇵Sapporo-shi, Hokkaido, Japan
Sapporo IBD Clinic /ID# 239054
🇯🇵Sapporo-shi, Hokkaido, Japan
Hyogo Medical University Hospital /ID# 239049
🇯🇵Nishinomiya-shi, Hyogo, Japan
Kanazawa University Hospital /ID# 239670
🇯🇵Kanazawa-shi, Ishikawa, Japan
Iwate Medical University Uchimaru Medical Center /ID# 238953
🇯🇵Morioka-shi, Iwate, Japan
St. Marianna University Hospital /ID# 239167
🇯🇵Kawasaki-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 239918
🇯🇵Kyoto-shi, Kyoto, Japan
Mie University Hospital /ID# 239758
🇯🇵Tsu-shi, Mie, Japan
Tohoku University Hospital /ID# 238476
🇯🇵Sendai-shi, Miyagi, Japan
Okayama University Hospital /ID# 239757
🇯🇵Okayama-shi, Okayama, Japan
Osaka Metropolitan University Hospital /ID# 238638
🇯🇵Osaka-shi, Osaka, Japan
Osaka University Hospital /ID# 240485
🇯🇵Suita-shi, Osaka, Japan
Hamamatsu University Hospital /ID# 238527
🇯🇵Hamamatsu-shi, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 239759
🇯🇵Sunto-gun, Shizuoka, Japan
Tokyo Medical And Dental University Hospital /ID# 238950
🇯🇵Bunkyo-ku, Tokyo, Japan
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700
🇰🇷Daejeon, Korea, Republic of
Kyorin University Hospital /ID# 239609
🇯🇵Mitaka-shi, Tokyo, Japan
Tokyo Medical University Hospital /ID# 239668
🇯🇵Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 239760
🇯🇵Shinjuku-ku, Tokyo, Japan
Asan Medical Center /ID# 233701
🇰🇷Seoul, Korea, Republic of
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554
🇯🇵Shinjuku-ku, Tokyo, Japan
Yamagata University Hospital /ID# 239572
🇯🇵Yamagata-shi, Yamagata, Japan
Samsung Medical Center /ID# 233698
🇰🇷Seoul, Korea, Republic of
Radboud Universitair Medisch Centrum /ID# 241292
🇳🇱Nijmegen, Gelderland, Netherlands
Academisch Medisch Centrum /ID# 232123
🇳🇱Amsterdam, Netherlands
Wellington Regional Hospital /ID# 238326
🇳🇿Newtown, Wellington, New Zealand
Hutt Hospital /ID# 238327
🇳🇿Lower Hutt, New Zealand
Dunedin Hospital /ID# 238325
🇳🇿Otago, New Zealand
Planetmed Sp. z o.o. /ID# 238447
🇵🇱Wroclaw, Dolnoslaskie, Poland
WIP Warsaw IBD Point Profesor Kierkus /ID# 233533
🇵🇱Warsaw, Mazowieckie, Poland
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653
🇵🇱Warszawa, Mazowieckie, Poland
Endoskopia Sp. z o.o. /ID# 249906
🇵🇱Sopot, Pomorskie, Poland
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047
🇵🇹Guimaraes, Braga, Portugal
Mindful Medical Research /ID# 249609
🇵🇷San Juan, Puerto Rico
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373
🇸🇰Banska Bystrica, Slovakia
ENDOMED s.r.o. /ID# 241855
🇸🇰Košice, Slovakia
KM Management, spol. s.r.o. /ID# 241849
🇸🇰Nitra, Slovakia
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 City, 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
2CA-Braga, Hospital de Braga /ID# 249049
🇵🇹Braga, Portugal
Digestive Health Specialists of the Southeast /ID# 239599
🇺🇸Dothan, Alabama, United States
East View Medical Research, LLC /ID# 240030
🇺🇸Mobile, Alabama, United States
Center hospital of the National Center for Global Health and Medicine /ID# 239792
🇯🇵Shinjuku-ku, Tokyo, Japan
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 231659
🇬🇷Pireaus, Greece
Atlantic Medical Research /ID# 233506
🇺🇸Margate, Florida, United States
AGILE Clinical Research Trials /ID# 233739
🇺🇸Atlanta, Georgia, United States
Gastroenterology Consultants, P.C /ID# 233552
🇺🇸Roswell, Georgia, United States
Louisiana Research Center, LLC /ID# 245370
🇺🇸Shreveport, Louisiana, United States
Allied Health Clinical Research Organization, LLC /ID# 241935
🇺🇸Englewood, New Jersey, United States
Toronto Digestive Disease Associates, Inc. /ID# 234143
🇨🇦Vaughan, Ontario, Canada