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

Who is this study for? Patients with moderately to severely active Crohn's disease
What treatments are being studied? ABBV-154
Status: Terminated
Location: See all (162) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Digestive Health Specialists of the Southeast /ID# 239599
Dothan
East View Medical Research, LLC /ID# 240030
Mobile
California
Southern California Res. Ctr. /ID# 233512
Coronado
Hoag Memorial Hosp Presbyterian /ID# 233555
Irvine
Colorado
University of Colorado Hospital /ID# 239361
Aurora
Connecticut
Medical Research Center of CT /ID# 233542
Hamden
Florida
Atlantic Medical Research /ID# 233506
Margate
University of Miami /ID# 233811
Miami
Gastroenterology Group Naples /ID# 233829
Naples
Digestive Disease Consultants - Orange Park /ID# 241015
Orange Park
Endoscopic Research, Inc. /ID# 234279
Orlando
IMIC Inc. Medical Research /ID# 233821
Palmetto Bay
Georgia
AGILE Clinical Research Trials /ID# 233739
Atlanta
Emory University /ID# 241014
Atlanta
Gastroenterology Associates of Central Georgia, LLC /ID# 245604
Macon
GI Specialists of GA, PC /ID# 239261
Marietta
Gastroenterology Consultants, P.C /ID# 233552
Roswell
Illinois
The University of Chicago DCAM /ID# 233824
Chicago
Digestive Health Services /ID# 241177
Downers Grove
Southwest Gastroenterology /ID# 234278
Oak Lawn
Kentucky
University of Louisville /ID# 233766
Louisville
Louisiana
Louisiana Research Center, LLC /ID# 245370
Shreveport
Michigan
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765
Ann Arbor
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763
Wyoming
Minnesota
Mayo Clinic - Rochester /ID# 238516
Rochester
North Carolina
Univ NC Chapel Hill /ID# 233557
Chapel Hill
New Jersey
Allied Health Clinical Research Organization, LLC /ID# 241935
Englewood
Nevada
Las Vegas Medical Research /ID# 233826
Las Vegas
New York
Lenox Hill Hospital /ID# 239312
New York
New York Gastroenterology Associates /ID# 241967
New York
The Mount Sinai Hospital /ID# 233823
New York
Ohio
Northshore Gastroentrology Research LLC /ID# 239307
Brooklyn
University of Cincinnati /ID# 234237
Cincinnati
Oklahoma
Digestive Disease Specialists /ID# 233825
Oklahoma City
Hightower Clinical /ID# 239598
Oklahoma City
Pennsylvania
University of Pennsylvania /ID# 239291
Philadelphia
Allegheny Health Network Research Institute /ID# 239334
Pittsburgh
South Carolina
Gastroenterology Associates, P.A. of Greenville /ID# 233544
Greenville
Tennessee
Gastro One /ID# 239748
Cordova
Texas
Southern Star Research Institute, LLC /ID# 240132
San Antonio
Tyler Research Institute, LLC /ID# 233730
Tyler
Gastro Health & Nutrition - Victoria /ID# 240158
Victoria
Utah
University of Utah Hospitals and Clinics /ID# 239264
Salt Lake City
Virginia
Gastro Health Research /ID# 240085
Fairfax
Hunter Holmes McGuire VA Medical Center /ID# 233759
Richmond
Other Locations
Australia
Royal Adelaide Hospital /ID# 233705
Adelaide
Monash Medical Centre /ID# 233469
Clayton
Concord Repatriation General /ID# 233467
Concord
Fiona Stanley Hospital /ID# 240136
Murdoch
The Queen Elizabeth Hospital /ID# 234242
Woodville South
Princess Alexandra Hospital /ID# 234243
Woolloongabba
Austria
Medizinische Universitaet Innsbruck /ID# 234217
Innsbruck
Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069
Salzburg
Medizinische Universitaet Wien /ID# 234218
Vienna
Belgium
AZ Maria Middelares /ID# 246880
Ghent
UZ Gent /ID# 246877
Ghent
CHU de Liege /ID# 232436
Liège
AZ-Delta /ID# 232437
Roeselare
UCL Saint-Luc /ID# 232435
Woluwe-saint-lambert
Bulgaria
UMHAT Kaspela /ID# 232468
Plovdiv
Acibadem City Clinic University Hospital EOOD /ID# 240003
Sofia
Second MHAT Sofia /ID# 250706
Sofia
UMHAT Sveti Ivan Rilski /ID# 233522
Sofia
UMHAT Tsaritsa Joanna - ISUL /ID# 234135
Sofia
Canada
University of Calgary /ID# 233838
Calgary
Gastroenterology and Internal Medicine Research Institution /ID# 233831
Edmonton
QE II Health Sciences Centre /ID# 233839
Halifax
London Health Sciences Center- University Hospital /ID# 234058
London
Scott Shulman Medicine Professional Corporation /ID# 239567
North Bay
Toronto Immune and Digestive Health Institute Inc /ID# 234142
North York
Toronto Digestive Disease Associates, Inc. /ID# 234143
Vaughan
France
CHU Montpellier - Hôpital Saint Eloi /ID# 241136
Montpellier
AP-HP - Hopital Saint-Louis /ID# 234227
Paris
CHU de SAINT ETIENNE - Hopital Nord /ID# 234225
Saint Priest En Jarez
CHRU Nancy - Hopitaux de Brabois /ID# 234224
Vandœuvre-lès-nancy
Germany
DRK Kliniken Berlin Westend /ID# 233718
Berlin
Universitaetsklinikum Erlangen /ID# 233529
Erlangen
Universitaetsklinikum Freiburg /ID# 233719
Freiburg Im Breisgau
Medizinische Hochschule Hannover /ID# 238804
Hanover
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527
Kiel
EUGASTRO GmbH /ID# 233717
Leipzig
Klinikum Lueneburg /ID# 233720
Lüneburg
Universitatsklinikum Mannheim /ID# 233716
Mannheim
Universitatsklinik Regensburg /ID# 238702
Regensburg
Universitaetsklinikum Ulm /ID# 233531
Ulm
Greece
General Hospital of Athens Ippokratio /ID# 231655
Athens
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660
Athens
University General Hospital of Heraklion PA.G.N.I /ID# 231657
Heraklion
General Hospital of Nikaia-Piraeus Agios Panteleimon /ID# 231659
Pireaus
Hungary
Clinfan Szolgaltato Kft. /ID# 249662
Szekszárd
Israel
The Edith Wolfson Medical Center /ID# 234042
Ashkelon
Soroka University Medical Center /ID# 233458
Beersheba
Hadassah Medical Center-Hebrew University /ID# 233518
Jerusalem
Shaare Zedek Medical Center /ID# 233460
Jerusalem
The Chaim Sheba Medical Center /ID# 233457
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 238525
Tel Aviv
Italy
Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387
Bari
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382
Milan
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386
Rho
Policlinico Agostino Gemelli /ID# 233380
Rome
Japan
Asahikawa City Hospital /ID# 248061
Asahikawa-shi
Tokyo Medical And Dental University Hospital /ID# 238950
Bunkyo-ku
Fukushima Medical University Hospital /ID# 239314
Fukushima
Hamamatsu University Hospital /ID# 238527
Hamamatsu
Hiroshima University Hospital /ID# 238947
Hiroshima
Kanazawa University Hospital /ID# 239670
Kanazawa
Tsujinaka Hospital Kashiwanoha /ID# 239012
Kashiwa-shi
St. Marianna University Hospital /ID# 239167
Kawasaki-shi
University Hospital Kyoto Prefectural University of Medicine /ID# 239918
Kyoto
Gunma University Hospital /ID# 239913
Maebashi
Kyorin University Hospital /ID# 239609
Mitaka-shi
Iwate Medical University Uchimaru Medical Center /ID# 238953
Morioka
Aichi Medical University Hospital /ID# 238528
Nagakute-shi
Daido Clinic /ID# 239730
Nagoya
Nagoya City University Hospital /ID# 238368
Nagoya
Nagoya University Hospital /ID# 238662
Nagoya
Hyogo Medical University Hospital /ID# 239049
Nishinomiya-shi
Okayama University Hospital /ID# 239757
Okayama
Osaka Metropolitan University Hospital /ID# 238638
Osaka
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791
Sapporo
Sapporo IBD Clinic /ID# 239054
Sapporo
Sapporo Medical University Hospital /ID# 239201
Sapporo
Tohoku University Hospital /ID# 238476
Sendai
Center hospital of the National Center for Global Health and Medicine /ID# 239792
Shinjuku-ku
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554
Shinjuku-ku
Tokyo Medical University Hospital /ID# 239668
Shinjuku-ku
Tokyo Women's Medical University Hospital /ID# 239760
Shinjuku-ku
Osaka University Hospital /ID# 240485
Suita-shi
NHO Shizuoka Medical Center /ID# 239759
Sunto-gun
Mie University Hospital /ID# 239758
Tsu
Yamagata University Hospital /ID# 239572
Yamagata
Netherlands
Academisch Medisch Centrum /ID# 232123
Amsterdam
Radboud Universitair Medisch Centrum /ID# 241292
Nijmegen
New Zealand
Hutt Hospital /ID# 238327
Lower Hutt
Wellington Regional Hospital /ID# 238326
Newtown
Dunedin Hospital /ID# 238325
Otago
Poland
Endoskopia Sp. z o.o. /ID# 249906
Sopot
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653
Warsaw
WIP Warsaw IBD Point Profesor Kierkus /ID# 233533
Warsaw
Planetmed Sp. z o.o. /ID# 238447
Wroclaw
Portugal
2CA-Braga, Hospital de Braga /ID# 249049
Braga
Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047
Guimarães
Puerto Rico
Mindful Medical Research /ID# 249609
San Juan
Republic of Korea
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700
Daejeon
Asan Medical Center /ID# 233701
Seoul
Samsung Medical Center /ID# 233698
Seoul
Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373
Banská Bystrica
ENDOMED s.r.o. /ID# 241855
Košice
KM Management, spol. s.r.o. /ID# 241849
Nitra
Spain
Hospital Santa Creu i Sant Pau /ID# 232301
Barcelona
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299
Ferrol
Hospital Universitario La Paz /ID# 232300
Madrid
Hospital Clinico Universitario de Valencia /ID# 234103
Valencia
Taiwan
China Medical University Hospital /ID# 234132
Taichung
Taichung Veterans General Hospital /ID# 234131
Taichung
National Taiwan University Hospital /ID# 234134
Taipei
United Kingdom
Royal Devon University Healthcare NHS Foundation Trust /ID# 234194
Exeter
NHS Greater Glasgow and Clyde /ID# 234186
Glasgow
Barts Health NHS Trust /ID# 234188
London
Guys and St Thomas NHS Foundation Trust /ID# 234191
London
University Hospital Southampton NHS Foundation Trust /ID# 238960
Southampton
St George's University Hospitals NHS Foundation Trust /ID# 234193
Tooting
Time Frame
Start Date: 2022-01-31
Completion Date: 2023-07-20
Participants
Target number of participants: 176
Treatments
Experimental: Induction Phase: ABBV-154 Randomized Dose A
Varying doses of ABBV-154 as described in the protocol.
Experimental: Induction Phase: ABBV-154 Randomized Dose B
Varying doses of ABBV-154 as described in the protocol.
Experimental: Induction Phase: ABBV-154 Randomized Dose C
Varying doses of ABBV-154 as described in the protocol.
Experimental: Induction Phase: ABBV-154 Randomized Dose D
Varying doses of ABBV-154 as described in the protocol.
Placebo_comparator: Induction Phase: Randomized Placebo
Fixed dose placebo as described in the protocol.
Experimental: Re-Induction Phase: ABBV-154 Randomized Dose A
Varying doses of ABBV-154 as described in the protocol.
Experimental: Re-Induction Phase: ABBV-154 Randomized Dose B
Varying doses of ABBV-154 as described in the protocol.
Experimental: Maintenance Phase: ABBV-154 Randomized Dose A
Fixed dose ABBV-154 every other week.
Experimental: Maintenance Phase: ABBV-154 Randomized Dose B
Fixed dose ABBV-154 every other week.
Placebo_comparator: Maintenance Phase: Randomized Placebo
Fixed dose placebo every other week.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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