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
• 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
• 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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

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