Clinical trial NCT05068284: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
ABBV-154
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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, ustekinumab, or risankizumab.

Exclusion Criteria:

- Participants with prior intolerance to adalimumab.

Primary outcomes:
measure: Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI)
timeFrame: Induction Period Week 12
measure: 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)
timeFrame: Induction Period Week 12
measure: Percentage of Participants Achieving Endoscopic Response Per SES-CD
timeFrame: Week 40 in the Maintenance Period
measure: Percentage of Participants Achieving Clinical Remission Per CDAI
timeFrame: Week 40 in the Maintenance Period
measure: Percentage of Participants Achieving Clinical Remission Per SF/AP
timeFrame: Week 40 in the Maintenance Period
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast /ID# 239599
state: Alabama
city: Mobile
country: United States
facility: East View Medical Research, LLC /ID# 240030
state: Alabama
city: Coronado
country: United States
facility: Southern California Res. Ctr. /ID# 233512
state: California
city: Irvine
country: United States
facility: Hoag Memorial Hosp Presbyterian /ID# 233555
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital /ID# 239361
state: Colorado
city: Hamden
country: United States
facility: Medical Research Center of CT /ID# 233542
state: Connecticut
city: Margate
country: United States
facility: Atlantic Medical Research /ID# 233506
state: Florida
city: Miami
country: United States
facility: University of Miami /ID# 233811
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Naples /ID# 233829
state: Florida
city: Orange Park
country: United States
facility: Digestive Disease Consultants - Orange Park /ID# 241015
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc. /ID# 234279
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC Inc. Medical Research /ID# 233821
state: Florida
city: Atlanta
country: United States
facility: Emory University /ID# 241014
state: Georgia
city: Atlanta
country: United States
facility: AGILE Clinical Research Trials /ID# 233739
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC /ID# 245604
state: Georgia
city: Marietta
country: United States
facility: GI Specialists of GA, PC /ID# 239261
state: Georgia
city: Roswell
country: United States
facility: Gastroenterology Consultants, P.C /ID# 233552
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago DCAM /ID# 233824
state: Illinois
city: Downers Grove
country: United States
facility: Digestive Health Services /ID# 241177
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology /ID# 234278
state: Illinois
city: Louisville
country: United States
facility: University of Louisville /ID# 233766
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC /ID# 245370
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 238516
state: Minnesota
city: Las Vegas
country: United States
facility: Las Vegas Medical Research /ID# 233826
state: Nevada
city: Englewood
country: United States
facility: Allied Health Clinical Research Organization, LLC /ID# 241935
state: New Jersey
city: New York
country: United States
facility: The Mount Sinai Hospital /ID# 233823
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital /ID# 239312
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates /ID# 241967
state: New York
city: Chapel Hill
country: United States
facility: Univ NC Chapel Hill /ID# 233557
state: North Carolina
city: Brooklyn
country: United States
facility: Northshore Gastroentrology Research LLC /ID# 239307
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 234237
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical /ID# 239598
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists /ID# 233825
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 239291
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network Research Institute /ID# 239334
state: Pennsylvania
city: Greenville
country: United States
facility: Gastroenterology Associates, P.A. of Greenville /ID# 233544
state: South Carolina
city: Cordova
country: United States
facility: Gastro One /ID# 239748
state: Tennessee
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC /ID# 240132
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC /ID# 233730
state: Texas
city: Victoria
country: United States
facility: Gastro Health & Nutrition - Victoria /ID# 240158
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics /ID# 239264
state: Utah
city: Fairfax
country: United States
facility: Gastro Health Research /ID# 240085
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center /ID# 233759
state: Virginia
city: Concord
country: Australia
facility: Concord Repatriation General /ID# 233467
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital /ID# 234243
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 233705
state: South Australia
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital /ID# 234242
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 233469
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital /ID# 240136
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck /ID# 234217
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universitaet Wien /ID# 234218
state: Wien
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069
city: Woluwe-Saint-Lambert
country: Belgium
facility: UCL Saint-Luc /ID# 232435
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 246877
state: Oost-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 232437
state: West-Vlaanderen
city: Gent
country: Belgium
facility: AZ Maria Middelares /ID# 246880
city: Liege
country: Belgium
facility: CHU de Liege /ID# 232436
city: Plovdiv
country: Bulgaria
facility: UMHAT Kaspela /ID# 232468
city: Sofia
country: Bulgaria
facility: Second MHAT Sofia /ID# 250706
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 233522
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Joanna - ISUL /ID# 234135
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Hospital EOOD /ID# 240003
city: Calgary
country: Canada
facility: University of Calgary /ID# 233838
state: Alberta
city: Edmonton
country: Canada
facility: Gastroenterology and Internal Medicine Research Institution /ID# 233831
state: Alberta
city: Halifax
country: Canada
facility: QE II Health Sciences Centre /ID# 233839
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Center- University Hospital /ID# 234058
state: Ontario
city: North Bay
country: Canada
facility: Scott Shulman Medicine Professional Corporation /ID# 239567
state: Ontario
city: North York
country: Canada
facility: Toronto Immune and Digestive Health Institute Inc /ID# 234142
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc. /ID# 234143
state: Ontario
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 239965
city: Ostrava
country: Czechia
facility: ARTROSCAN s.r.o. /ID# 239882
city: Prague 6
country: Czechia
facility: Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486
city: Praha
country: Czechia
facility: Nemocnice Horovice - NH Hospital a.s /ID# 233915
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hôpital Saint Eloi /ID# 241136
state: Herault
city: St. Priest En Jarez
country: France
facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 234225
state: Loire
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Hopitaux de Brabois /ID# 234224
state: Meurthe-et-Moselle
city: Paris
country: France
facility: AP-HP - Hopital Saint-Louis /ID# 234227
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg /ID# 233719
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim /ID# 233716
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 233531
state: Baden-Wuerttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 233529
state: Bayern
city: Ratisbon
country: Germany
facility: Universitatsklinik Regensburg /ID# 238702
state: Bayern
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend /ID# 233718
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover /ID# 238804
city: Leipzig
country: Germany
facility: EUGASTRO GmbH /ID# 233717
city: Lueneburg
country: Germany
facility: Klinikum Lueneburg /ID# 233720
city: Athens
country: Greece
facility: General Hospital of Athens Ippokratio /ID# 231655
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 231657
state: Kriti
city: Pireaus
country: Greece
facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 231659
city: Szekszard
country: Hungary
facility: Clinfan Szolgaltato Kft. /ID# 249662
city: Ashkelon
country: Israel
facility: The Edith Wolfson Medical Center /ID# 234042
state: HaDarom
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 233458
state: HaDarom
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 233457
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 238525
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 233460
state: Yerushalayim
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 233518
state: Yerushalayim
city: Rho
country: Italy
facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386
state: Milano
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli /ID# 233380
state: Roma
city: Bari
country: Italy
facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital /ID# 238528
state: Aichi
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 238368
state: Aichi
city: Nagoya-shi
country: Japan
facility: Daido Clinic /ID# 239730
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 238662
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha /ID# 239012
state: Chiba
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 239314
state: Fukushima
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 239913
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 238947
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Asahikawa City Hospital /ID# 248061
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital /ID# 239201
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo IBD Clinic /ID# 239054
state: Hokkaido
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 239049
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 239670
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Iwate Medical University Uchimaru Medical Center /ID# 238953
state: Iwate
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital /ID# 239167
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 239918
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 239758
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 238476
state: Miyagi
city: Okayama-shi
country: Japan
facility: Okayama University Hospital /ID# 239757
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 238638
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 240485
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 238527
state: Shizuoka
city: Sunto-gun
country: Japan
facility: NHO Shizuoka Medical Center /ID# 239759
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital /ID# 238950
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital /ID# 239609
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 239668
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Center hospital of the National Center for Global Health and Medicine /ID# 239792
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 239760
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 239572
state: Yamagata
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 233701
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 233698
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum /ID# 241292
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum /ID# 232123
city: Newtown
country: New Zealand
facility: Wellington Regional Hospital /ID# 238326
state: Wellington
city: Lower Hutt
country: New Zealand
facility: Hutt Hospital /ID# 238327
city: Otago
country: New Zealand
facility: Dunedin Hospital /ID# 238325
city: Wroclaw
country: Poland
facility: Planetmed Sp. z o.o. /ID# 238447
state: Dolnoslaskie
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 233533
state: Mazowieckie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653
state: Mazowieckie
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o. /ID# 249906
state: Pomorskie
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047
state: Braga
city: Braga
country: Portugal
facility: 2CA-Braga, Hospital de Braga /ID# 249049
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 249609
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373
city: Košice
country: Slovakia
facility: ENDOMED s.r.o. /ID# 241855
city: Nitra
country: Slovakia
facility: KM Management, spol. s.r.o. /ID# 241849
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299
state: A Coruna
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 232301
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 232300
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia /ID# 234103
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 234132
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 234131
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 234134
city: Exeter
country: United Kingdom
facility: Royal Devon University Healthcare NHS Foundation Trust /ID# 234194
state: Devon
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust /ID# 238960
state: Hampshire
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 234188
state: London, City Of
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 234191
state: London, City Of
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 234186
state: Scotland
city: Tooting
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust /ID# 234193
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: