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)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD

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.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: ABBV-154; Drug: ABBV-154; Drug: Placebo; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General /ID# 233467
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital /ID# 234243
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 233705
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital /ID# 234242
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre /ID# 233469
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital /ID# 240136
• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medizinische Universitaet Innsbruck /ID# 234217
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 234218
• Belgium
  • Gent, Belgium, 9000
    • AZ Maria Middelares /ID# 246880
  • Liege, Belgium, 4000
    • CHU de Liege /ID# 232436
  • Bruxelles-Capitale
    • Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
      • UCL Saint-Luc /ID# 232435
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 246877
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • AZ-Delta /ID# 232437
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela /ID# 232468
  • Sofia, Bulgaria, 1202
    • Second MHAT Sofia /ID# 250706
  • Sofia, Bulgaria, 1431
    • UMHAT Sveti Ivan Rilski /ID# 233522
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Joanna - ISUL /ID# 234135
  • Sofia, Bulgaria, 1784
    • Acibadem City Clinic University Hospital EOOD /ID# 240003
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 233838
    • Edmonton, Alberta, Canada, T5R 1W2
      • Gastroenterology and Internal Medicine Research Institution /ID# 233831
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • QE II Health Sciences Centre /ID# 233839
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Center- University Hospital /ID# 234058
    • North Bay, Ontario, Canada, P1B 2H3
      • Scott Shulman Medicine Professional Corporation /ID# 239567
    • North York, Ontario, Canada, M6A 3B4
      • Toronto Immune and Digestive Health Institute Inc /ID# 234142
    • Vaughan, Ontario, Canada, L4L 4Y7
      • Toronto Digestive Disease Associates, Inc. /ID# 234143
• Czechia
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o. /ID# 239965
  • Ostrava, Czechia, 722 00
    • ARTROSCAN s.r.o. /ID# 239882
  • Prague 6, Czechia, 162 00
    • Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486
  • Praha, Czechia, 155 00
    • Nemocnice Horovice - NH Hospital a.s /ID# 233915
• France
  • Paris, France, 75010
    • AP-HP - Hopital Saint-Louis /ID# 234227
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • CHU Montpellier - Hôpital Saint Eloi /ID# 241136
  • Loire
    • St. Priest En Jarez, Loire, France, 42270
      • CHU de SAINT ETIENNE - Hopital Nord /ID# 234225
  • Meurthe-et-Moselle
    • Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU Nancy - Hopitaux de Brabois /ID# 234224
• Germany
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend /ID# 233718
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover /ID# 238804
  • Leipzig, Germany, 04103
    • EUGASTRO GmbH /ID# 233717
  • Lueneburg, Germany, 21339
    • Klinikum Lueneburg /ID# 233720
  • Baden-Wuerttemberg
    • Freiburg, Baden-Wuerttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg /ID# 233719
    • Mannheim, Baden-Wuerttemberg, Germany, 68167
      • Universitatsklinikum Mannheim /ID# 233716
    • Ulm, Baden-Wuerttemberg, Germany, 89081
      • Universitaetsklinikum Ulm /ID# 233531
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 233529
    • Ratisbon, Bayern, Germany, 93053
      • Universitatsklinik Regensburg /ID# 238702
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527
• Greece
  • Pireaus, Greece, 18454
    • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 231659
  • Attiki
    • Athens, Attiki, Greece, 11527
      • General Hospital of Athens Ippokratio /ID# 231655
    • Athens, Attiki, Greece, 11527
      • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660
  • Kriti
    • Heraklion, Kriti, Greece, 71500
      • University General Hospital of Heraklion PA.G.N.I /ID# 231657
• Hungary
  • Szekszard, Hungary, 7100
    • Clinfan Szolgaltato Kft. /ID# 249662
• Israel
  • HaDarom
    • Ashkelon, HaDarom, Israel, 5822000
      • The Edith Wolfson Medical Center /ID# 234042
    • Be'er Sheva, HaDarom, Israel, 8410101
      • Soroka University Medical Center /ID# 233458
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 233457
    • Tel Aviv, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 238525
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 233518
    • Jerusalem, Yerushalayim, Israel, 91031
      • Shaare Zedek Medical Center /ID# 233460
• Italy
  • Bari, Italy, 70124
    • Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382
  • Milano
    • Rho, Milano, Italy, 20017
      • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386
  • Roma
    • Rome, Roma, Italy, 00168
      • Policlinico Agostino Gemelli /ID# 233380
• Japan
  • Aichi
    • Nagakute-shi, Aichi, Japan, 480-1195
      • Aichi Medical University Hospital /ID# 238528
    • Nagoya shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 238368
    • Nagoya-shi, Aichi, Japan, 457-8511
      • Daido Clinic /ID# 239730
    • Nagoya-shi, Aichi, Japan, 4668560
      • Nagoya University Hospital /ID# 238662
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-0871
      • Tsujinaka Hospital Kashiwanoha /ID# 239012
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 239314
  • Gunma
    • Maebashi-shi, Gunma, Japan, 371-8511
      • Gunma University Hospital /ID# 239913
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 734-8551
      • Hiroshima University Hospital /ID# 238947
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8610
      • Asahikawa City Hospital /ID# 248061
    • Sapporo-shi, Hokkaido, Japan, 060-0033
      • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791
    • Sapporo-shi, Hokkaido, Japan, 060-8543
      • Sapporo Medical University Hospital /ID# 239201
    • Sapporo-shi, Hokkaido, Japan, 064-0919
      • Sapporo IBD Clinic /ID# 239054
  • Hyogo
    • Nishinomiya-shi, Hyogo, Japan, 663-8501
      • Hyogo Medical University Hospital /ID# 239049
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital /ID# 239670
  • Iwate
    • Morioka-shi, Iwate, Japan, 020-8505
      • Iwate Medical University Uchimaru Medical Center /ID# 238953
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital /ID# 239167
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 602-8566
      • University Hospital Kyoto Prefectural University of Medicine /ID# 239918
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 239758
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 238476
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 239757
  • Osaka
    • Osaka-shi, Osaka, Japan, 545-8586
      • Osaka Metropolitan University Hospital /ID# 238638
    • Suita-shi, Osaka, Japan, 565-0871
      • Osaka University Hospital /ID# 240485
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital /ID# 238527
    • Sunto-gun, Shizuoka, Japan, 411-8611
      • NHO Shizuoka Medical Center /ID# 239759
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical And Dental University Hospital /ID# 238950
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Kyorin University Hospital /ID# 239609
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital /ID# 239668
    • Shinjuku-ku, Tokyo, Japan, 162-8655
      • Center hospital of the National Center for Global Health and Medicine /ID# 239792
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital /ID# 239760
    • Shinjuku-ku, Tokyo, Japan, 169-0073
      • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 239572
• Korea, Republic of
  • Daejeon, Korea, Republic of, 34943
    • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 233701
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 233698
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum /ID# 232123
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum /ID# 241292
• New Zealand
  • Lower Hutt, New Zealand, 5010
    • Hutt Hospital /ID# 238327
  • Otago, New Zealand, 9016
    • Dunedin Hospital /ID# 238325
  • Wellington
    • Newtown, Wellington, New Zealand, 6021
      • Wellington Regional Hospital /ID# 238326
• Poland
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 52-210
      • Planetmed Sp. z o.o. /ID# 238447
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 00-728
      • WIP Warsaw IBD Point Profesor Kierkus /ID# 233533
    • Warszawa, Mazowieckie, Poland, 02-507
      • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653
  • Pomorskie
    • Sopot, Pomorskie, Poland, 81-756
      • Endoskopia Sp. z o.o. /ID# 249906
• Portugal
  • Braga, Portugal, 4710-243
    • 2CA-Braga, Hospital de Braga /ID# 249049
  • Braga
    • Guimaraes, Braga, Portugal, 4835-044
      • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047
• Puerto Rico
  • San Juan, Puerto Rico, 00918-3756
    • Mindful Medical Research /ID# 249609
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373
  • Košice, Slovakia, 040 01
    • ENDOMED s.r.o. /ID# 241855
  • Nitra, Slovakia, 949 01
    • KM Management, spol. s.r.o. /ID# 241849
• Spain
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 232301
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 232300
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 234103
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 234132
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 234131
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 234134
• United Kingdom
  • Tooting, United Kingdom, SW17 0QT
    • St George's University Hospitals NHS Foundation Trust /ID# 234193
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Royal Devon University Healthcare NHS Foundation Trust /ID# 234194
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS Foundation Trust /ID# 238960
  • London, City Of
    • London, London, City Of, United Kingdom, E1 2ES
      • Barts Health NHS Trust /ID# 234188
    • London, London, City Of, United Kingdom, SE1 9RT
      • Guys and St Thomas NHS Foundation Trust /ID# 234191
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • NHS Greater Glasgow and Clyde /ID# 234186
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists of the Southeast /ID# 239599
    • Mobile, Alabama, United States, 36606
      • East View Medical Research, LLC /ID# 240030
  • California
    • Coronado, California, United States, 92118-1408
      • Southern California Res. Ctr. /ID# 233512
    • Irvine, California, United States, 92618
      • Hoag Memorial Hosp Presbyterian /ID# 233555
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital /ID# 239361
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of CT /ID# 233542
  • Florida
    • Margate, Florida, United States, 33063-5737
      • Atlantic Medical Research /ID# 233506
    • Miami, Florida, United States, 33136
      • University of Miami /ID# 233811
    • Naples, Florida, United States, 34102
      • Gastroenterology Group Naples /ID# 233829
    • Orange Park, Florida, United States, 32073
      • Digestive Disease Consultants - Orange Park /ID# 241015
    • Orlando, Florida, United States, 32803
      • Endoscopic Research, Inc. /ID# 234279
    • Palmetto Bay, Florida, United States, 33157
      • IMIC Inc. Medical Research /ID# 233821
  • Georgia
    • Atlanta, Georgia, United States, 30322-1013
      • Emory University /ID# 241014
    • Atlanta, Georgia, United States, 30328-5532
      • AGILE Clinical Research Trials /ID# 233739
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC /ID# 245604
    • Marietta, Georgia, United States, 30060
      • GI Specialists of GA, PC /ID# 239261
    • Roswell, Georgia, United States, 30076-4913
      • Gastroenterology Consultants, P.C /ID# 233552
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago DCAM /ID# 233824
    • Downers Grove, Illinois, United States, 60515-1552
      • Digestive Health Services /ID# 241177
    • Oak Lawn, Illinois, United States, 60453
      • Southwest Gastroenterology /ID# 234278
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville /ID# 233766
  • Louisiana
    • Shreveport, Louisiana, United States, 71105-6800
      • Louisiana Research Center, LLC /ID# 245370
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 238516
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research /ID# 233826
  • New Jersey
    • Englewood, New Jersey, United States, 07631-4152
      • Allied Health Clinical Research Organization, LLC /ID# 241935
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital /ID# 233823
    • New York, New York, United States, 10075
      • Lenox Hill Hospital /ID# 239312
    • New York, New York, United States, 10075
      • New York Gastroenterology Associates /ID# 241967
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Univ NC Chapel Hill /ID# 233557
  • Ohio
    • Brooklyn, Ohio, United States, 44144
      • Northshore Gastroentrology Research LLC /ID# 239307
    • Cincinnati, Ohio, United States, 45267-0585
      • University of Cincinnati /ID# 234237
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical /ID# 239598
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists /ID# 233825
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 239291
    • Pittsburgh, Pennsylvania, United States, 15224
      • Allegheny Health Network Research Institute /ID# 239334
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Gastroenterology Associates, P.A. of Greenville /ID# 233544
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Gastro One /ID# 239748
  • Texas
    • San Antonio, Texas, United States, 78229-5390
      • Southern Star Research Institute, LLC /ID# 240132
    • Tyler, Texas, United States, 75701-4464
      • Tyler Research Institute, LLC /ID# 233730
    • Victoria, Texas, United States, 77904
      • Gastro Health & Nutrition - Victoria /ID# 240158
  • Utah
    • Salt Lake City, Utah, United States, 84132-0001
      • University of Utah Hospitals and Clinics /ID# 239264
  • Virginia
    • Fairfax, Virginia, United States, 22031-4622
      • Gastro Health Research /ID# 240085
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center /ID# 233759

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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, ustekinumab, or risankizumab.

Exclusion Criteria:

- Participants with prior intolerance to adalimumab.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction Phase: ABBV-154 Randomized Dose A; Varying doses of ABBV-154 as described in the protocol.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection
Experimental: Induction Phase: ABBV-154 Randomized Dose B; Varying doses of ABBV-154 as described in the protocol.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection
Experimental: Induction Phase: ABBV-154 Randomized Dose C; Varying doses of ABBV-154 as described in the protocol.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection
Experimental: Induction Phase: ABBV-154 Randomized Dose D; Varying doses of ABBV-154 as described in the protocol.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection; Drug: Placebo; Intravenous (IV) infusion; Subcutaneous Injection; Drug: Placebo; Subcutaneous Injection
Placebo Comparator: Induction Phase: Randomized Placebo; Fixed dose placebo as described in the protocol.	Drug: Placebo; Intravenous (IV) infusion; Subcutaneous Injection; Drug: Placebo; Subcutaneous Injection
Experimental: Re-Induction Phase: ABBV-154 Randomized Dose A; Varying doses of ABBV-154 as described in the protocol.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection
Experimental: Re-Induction Phase: ABBV-154 Randomized Dose B; Varying doses of ABBV-154 as described in the protocol.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection
Experimental: Maintenance Phase: ABBV-154 Randomized Dose A; Fixed dose ABBV-154 every other week.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection
Experimental: Maintenance Phase: ABBV-154 Randomized Dose B; Fixed dose ABBV-154 every other week.	Drug: ABBV-154; Intravenous (IV) Infusion; Subcutaneous Injection; Drug: ABBV-154; Subcutaneous Injection
Placebo Comparator: Maintenance Phase: Randomized Placebo; Fixed dose placebo every other week.	Drug: Placebo; Intravenous (IV) infusion; Subcutaneous Injection; Drug: Placebo; Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)	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.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI)	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.	Induction Period Week 12
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)	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.	Induction Period Week 12
Percentage of Participants Achieving Endoscopic Response Per SES-CD	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).	Week 40 in the Maintenance Period
Percentage of Participants Achieving Clinical Remission Per CDAI	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.	Week 40 in the Maintenance Period
Percentage of Participants Achieving Clinical Remission Per SF/AP	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.	Week 40 in the Maintenance Period

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: September 5, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Crohn's Disease; ABBV-154
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: M20-371; 2021-002869-18 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes