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NCT05068284 Clinical Trial

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

Crohn's Disease Clinical Trial

— AIM-CD  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05068284
Other study ID # M20-371
Secondary ID 2021-002869-18
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 31, 2022
Est. completion date July 20, 2023

Study information
Verified date July 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 compromised 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.

Recruitment information / eligibility
Status Terminated
Enrollment 176
Est. completion date July 20, 2023
Est. primary completion date July 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection
• Placebo
Intravenous (IV) infusion; Subcutaneous Injection
• ABBV-154
Subcutaneous Injection
• Placebo
Subcutaneous Injection

Locations
Country Name City State
Australia Royal Adelaide Hospital /ID# 233705 Adelaide South Australia
Australia Monash Medical Centre /ID# 233469 Clayton Victoria
Australia Concord Repatriation General /ID# 233467 Concord New South Wales
Australia Fiona Stanley Hospital /ID# 240136 Murdoch Western Australia
Australia The Queen Elizabeth Hospital /ID# 234242 Woodville South South Australia
Australia Princess Alexandra Hospital /ID# 234243 Woolloongabba Queensland
Austria Medizinische Universitaet Innsbruck /ID# 234217 Innsbruck Tirol
Austria Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069 Salzburg
Austria Medizinische Universitaet Wien /ID# 234218 Vienna Wien
Belgium AZ Maria Middelares /ID# 246880 Gent
Belgium UZ Gent /ID# 246877 Gent Oost-Vlaanderen
Belgium CHU de Liege /ID# 232436 Liege
Belgium AZ-Delta /ID# 232437 Roeselare West-Vlaanderen
Belgium UCL Saint-Luc /ID# 232435 Woluwe-Saint-Lambert Bruxelles-Capitale
Bulgaria UMHAT Kaspela /ID# 232468 Plovdiv
Bulgaria Acibadem City Clinic University Hospital EOOD /ID# 240003 Sofia
Bulgaria Second MHAT Sofia /ID# 250706 Sofia
Bulgaria UMHAT Sveti Ivan Rilski /ID# 233522 Sofia
Bulgaria UMHAT Tsaritsa Joanna - ISUL /ID# 234135 Sofia
Canada 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 Asso /ID# 234143 Vaughan Ontario
Czechia 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
France CHU Montpellier - Hôpital Saint Eloi /ID# 241136 Montpellier Cedex 5 Herault
France AP-HP - Hopital Saint-Louis /ID# 234227 Paris
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
Germany DRK Kliniken Berlin Westend /ID# 233718 Berlin
Germany Universitaetsklinikum Erlangen /ID# 233529 Erlangen Bayern
Germany Universitaetsklinikum Freiburg /ID# 233719 Freiburg Baden-Wuerttemberg
Germany Medizinische Hochschule Hannover /ID# 238804 Hannover
Germany Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527 Kiel Schleswig-Holstein
Germany EUGASTRO GmbH /ID# 233717 Leipzig
Germany Klinikum Lueneburg /ID# 233720 Lueneburg
Germany Universitatsklinikum Mannheim /ID# 233716 Mannheim Baden-Wuerttemberg
Germany Universitatsklinik Regensburg /ID# 238702 Ratisbon Bayern
Germany Universitaetsklinikum Ulm /ID# 233531 Ulm Baden-Wuerttemberg
Greece 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 General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 231659 Pireaus
Hungary Clinfan Szolgaltato Kft. /ID# 249662 Szekszard
Israel Soroka University Medical Center /ID# 233458 Beer Sheva HaDarom
Israel The Edith Wolfson Medical Center /ID# 234042 Holon
Israel Hadassah Medical Center-Hebrew University /ID# 233518 Jerusalem Yerushalayim
Israel Shaare Zedek Medical Center /ID# 233460 Jerusalem
Israel The Chaim Sheba Medical Center /ID# 233457 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 238525 Tel Aviv-Yafo Tel-Aviv
Italy Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387 Bari
Italy Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382 Milan
Italy ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386 Rho Milano
Italy Policlinico Agostino Gemelli /ID# 233380 Rome Lazio
Japan Asahikawa City Hospital /ID# 248061 Asahikawa-shi Hokkaido
Japan Tokyo Medical And Dental University Hospital /ID# 238950 Bunkyo-ku Tokyo
Japan Fukushima Medical University Hospital /ID# 239314 Fukushima-shi Fukushima
Japan Hamamatsu University Hospital /ID# 238527 Hamamatsu-shi Shizuoka
Japan Hiroshima University Hospital /ID# 238947 Hiroshima-shi Hiroshima
Japan Kanazawa University Hospital /ID# 239670 Kanazawa-shi Ishikawa
Japan Tsujinaka Hospital Kashiwanoha /ID# 239012 Kashiwa-shi Chiba
Japan St. Marianna University Hospital /ID# 239167 Kawasaki-shi Kanagawa
Japan University Hospital Kyoto Prefectural University of Medicine /ID# 239918 Kyoto-shi Kyoto
Japan Gunma University Hospital /ID# 239913 Maebashi-shi Gunma
Japan Kyorin University Hospital /ID# 239609 Mitaka-shi Tokyo
Japan Iwate Medical University Uchimaru Medical Center /ID# 238953 Morioka-shi Iwate
Japan 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 Hyogo Medical University Hospital /ID# 239049 Nishinomiya-shi Hyogo
Japan Okayama University Hospital /ID# 239757 Okayama-shi Okayama
Japan Osaka Metropolitan University Hospital /ID# 238638 Osaka-shi Osaka
Japan Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791 Sapporo-shi Hokkaido
Japan Sapporo IBD Clinic /ID# 239054 Sapporo-shi Hokkaido
Japan Sapporo Medical University Hospital /ID# 239201 Sapporo-shi Hokkaido
Japan Tohoku University Hospital /ID# 238476 Sendai-shi Miyagi
Japan Center Hospital of the National Center for Global Health and Medicine /ID# 239792 Shinjuku-ku Tokyo
Japan Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554 Shinjuku-ku Tokyo
Japan Tokyo Medical University Hospital /ID# 239668 Shinjuku-ku Tokyo
Japan Tokyo Women's Medical University Hospital /ID# 239760 Shinjuku-ku Tokyo
Japan Osaka University Hospital /ID# 240485 Suita-shi Osaka
Japan NHO Shizuoka Medical Center /ID# 239759 Sunto-gun Shizuoka
Japan Mie University Hospital /ID# 239758 Tsu-shi Mie
Japan Yamagata University Hospital /ID# 239572 Yamagata-shi Yamagata
Korea, Republic of The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700 Daejeon
Korea, Republic of Asan Medical Center /ID# 233701 Seoul
Korea, Republic of Samsung Medical Center /ID# 233698 Seoul
Netherlands Academisch Medisch Centrum /ID# 232123 Amsterdam
Netherlands Radboud Universitair Medisch Centrum /ID# 241292 Nijmegen Gelderland
New Zealand Hutt Hospital /ID# 238327 Lower Hutt
New Zealand Wellington Regional Hospital /ID# 238326 Newtown Wellington
New Zealand Dunedin Hospital /ID# 238325 Otago
Poland Endoskopia Sp. z o.o. /ID# 249906 Sopot Pomorskie
Poland WIP Warsaw IBD Point Profesor Kierkus /ID# 233533 Warsaw Mazowieckie
Poland Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653 Warszawa Mazowieckie
Poland Planetmed Sp. z o.o. /ID# 238447 Wroclaw Dolnoslaskie
Portugal CCA Braga - Hospital de Braga /ID# 249049 Braga
Portugal Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047 Guimaraes Braga
Puerto Rico Mindful Medical Research /ID# 249609 San Juan
Slovakia 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
Spain Hospital Santa Creu i Sant Pau /ID# 232301 Barcelona
Spain Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299 Ferrol A Coruna
Spain Hospital Universitario La Paz /ID# 232300 Madrid
Spain Hospital Clinico Universitario de Valencia /ID# 234103 Valencia
Taiwan China Medical University Hospital /ID# 234132 Taichung
Taiwan Taichung Veterans General Hospital /ID# 234131 Taichung
Taiwan National Taiwan University Hospital /ID# 234134 Taipei City
United Kingdom Royal Devon University Healthcare NHS Foundation Trust /ID# 234194 Exeter Devon
United Kingdom NHS Greater Glasgow and Clyde /ID# 234186 Glasgow Scotland
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 University Hospital Southampton NHS Foundation Trust /ID# 238960 Southampton Hampshire
United Kingdom St George's University Hospitals NHS Foundation Trust /ID# 234193 Tooting
United States University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765 Ann Arbor Michigan
United States Agile Clinical Research Trials /ID# 233739 Atlanta Georgia
United States Emory University /ID# 241014 Atlanta Georgia
United States University of Colorado Hospital /ID# 239361 Aurora Colorado
United States Northshore Gastroentrology Research LLC /ID# 239307 Brooklyn Ohio
United States Univ NC Chapel Hill /ID# 233557 Chapel Hill North Carolina
United States The University of Chicago DCAM /ID# 233824 Chicago Illinois
United States University of Cincinnati /ID# 234237 Cincinnati Ohio
United States Gastro One /ID# 239748 Cordova Tennessee
United States Southern California Res. Ctr. /ID# 233512 Coronado California
United States Digestive Health Specialists of the Southeast /ID# 239599 Dothan Alabama
United States Digestive Health Services /ID# 241177 Downers Grove Illinois
United States Gastroenterology Group of Northern NJ - Englewood Division /ID# 241935 Englewood New Jersey
United States Gastro Health Research /ID# 240085 Fairfax Virginia
United States Gastroenterology Associates, P.A. of Greenville /ID# 233544 Greenville South Carolina
United States Medical Research Center of CT /ID# 233542 Hamden Connecticut
United States Hoag Memorial Hosp Presbyterian /ID# 233555 Irvine California
United States Las Vegas Medical Research /ID# 233826 Las Vegas Nevada
United States University of Louisville /ID# 233766 Louisville Kentucky
United States Gastroenterology Associates of Central Georgia, LLC /ID# 245604 Macon Georgia
United States Atlantic Medical Research Group /ID# 233506 Margate Florida
United States GI Specialists of GA, PC /ID# 239261 Marietta Georgia
United States University of Miami /ID# 233811 Miami Florida
United States East View Medical Research, LLC /ID# 240030 Mobile Alabama
United States Gastroenterology Group Naples /ID# 233829 Naples Florida
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 The Mount Sinai Hospital /ID# 233823 New York New York
United States Southwest Gastroenterology /ID# 234278 Oak Lawn Illinois
United States Digestive Disease Specialists /ID# 233825 Oklahoma City Oklahoma
United States Hightower Clinical /ID# 239598 Oklahoma City Oklahoma
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 University of Pennsylvania /ID# 239291 Philadelphia Pennsylvania
United States Allegheny Health Network Research Institute /ID# 239334 Pittsburgh Pennsylvania
United States Hunter Holmes McGuire VA Medical Center /ID# 233759 Richmond Virginia
United States Mayo Clinic - Rochester /ID# 238516 Rochester Minnesota
United States Gastroenterology Consultants PC - Roswell /ID# 233552 Roswell Georgia
United States University of Utah Hospitals and Clinics /ID# 239264 Salt Lake City Utah
United States Southern Star Research Institute, LLC /ID# 240132 San Antonio Texas
United States Louisana Research Center, LLC /ID# 245370 Shreveport Louisiana
United States Tyler Research Institute, LLC /ID# 233730 Tyler Texas
United States Gastro Health & Nutrition - Victoria /ID# 240158 Victoria Texas
United States Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763 Wyoming Michigan

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Week 12 in the Induction Period
Secondary 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. Week 12 in the Induction Period
Secondary 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 SF <= 2.8 and not worse than Baseline and average daily AP score <= 1 and not worse than Baseline. Week 12 in the Induction Period
Secondary 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
Secondary 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
Secondary 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
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