AIM-CD: 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05068284

Collaborator

(none)

265

Enrollment

172

Locations

Arms

53.1

Anticipated Duration (Months)

1.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 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. Participants with inadequate response at/after Week 4 of the maintenance period will be eligible to receive ABBV-154 rescue therapy.

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: ABBV-154 Drug: Placebo Drug: ABBV-154 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

265 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 31, 2022

Anticipated Primary Completion Date :

Jan 2, 2024

Anticipated Study Completion Date :

Jul 4, 2026

Arms and Interventions

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
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
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
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: Placebo Subcutaneous Injection
Placebo Comparator: Induction Phase: Randomized Placebo Fixed dose placebo as described in the protocol.	Drug: Placebo Intravenous (IV) infusion; 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
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
Experimental: Maintenance Phase: ABBV-154 Randomized Dose A Fixed dose ABBV-154 every other week.	Drug: ABBV-154 Subcutaneous Injection
Experimental: Maintenance Phase: ABBV-154 Randomized Dose B Fixed dose ABBV-154 every other week.	Drug: ABBV-154 Subcutaneous Injection
Placebo Comparator: Maintenance Phase: Randomized Placebo Fixed dose placebo every other week.	Drug: Placebo Subcutaneous Injection

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD) [Week 12 in the Induction Period]
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).

Secondary Outcome Measures

Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) [Week 12 in the Induction Period]
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.
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) [Week 12 in the Induction Period]
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.
Percentage of Participants Achieving Endoscopic Response per SES-CD [Week 40 in the Maintenance Period]
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).
Percentage of Participants Achieving Clinical Remission per CDAI [Week 40 in the Maintenance Period]
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.
Percentage of Participants Achieving Clinical Remission per SF/AP [Week 40 in the Maintenance Period]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, or ustekinumab.

Exclusion Criteria:

Participants with prior intolerance to adalimumab.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Digestive Health Specialists of the Southeast /ID# 239599	Dothan	Alabama	United States	36305
2	East View Medical Research, LLC /ID# 240030	Mobile	Alabama	United States	36606
3	Southern California Res. Ctr. /ID# 233512	Coronado	California	United States	92118-1408
4	Hoag Memorial Hosp Presbyterian /ID# 233555	Irvine	California	United States	92618
5	Stanford University /ID# 239982	Palo Alto	California	United States	94304
6	University of Colorado Hospital /ID# 239361	Aurora	Colorado	United States	80045
7	Medical Research Center of CT /ID# 233542	Hamden	Connecticut	United States	06518
8	Atlantic Medical Research Group /ID# 233506	Margate	Florida	United States	33063-5737
9	University of Miami /ID# 233811	Miami	Florida	United States	33136
10	Gastroenterology Group Naples /ID# 233829	Naples	Florida	United States	34102
11	Digestive Disease Consultants - Orange Park /ID# 241015	Orange Park	Florida	United States	32073
12	IMIC Inc. Medical Research /ID# 233821	Palmetto Bay	Florida	United States	33157
13	Emory University /ID# 241014	Atlanta	Georgia	United States	30322-1013
14	Agile Clinical Research Trials /ID# 233739	Atlanta	Georgia	United States	30328-5532
15	Gastroenterology Associates of Central Georgia, LLC /ID# 245604	Macon	Georgia	United States	31201
16	GI Specialists of GA, PC /ID# 239261	Marietta	Georgia	United States	30060
17	Gastroenterology Consultants PC - Roswell /ID# 233552	Roswell	Georgia	United States	30076-4913
18	The University of Chicago DCAM /ID# 233824	Chicago	Illinois	United States	60637
19	Digestive Health Services /ID# 241177	Downers Grove	Illinois	United States	60515-1552
20	Southwest Gastroenterology /ID# 234278	Oak Lawn	Illinois	United States	60453
21	University of Louisville /ID# 233766	Louisville	Kentucky	United States	40202
22	Louisana Research Center, LLC /ID# 245370	Shreveport	Louisiana	United States	71105-6800
23	University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765	Ann Arbor	Michigan	United States	48109
24	Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763	Wyoming	Michigan	United States	49519
25	Mayo Clinic - Rochester /ID# 238516	Rochester	Minnesota	United States	55905-0001
26	Las Vegas Medical Research /ID# 233826	Las Vegas	Nevada	United States	89113
27	Gastroenterology Group of Northern NJ - Englewood Division /ID# 241935	Englewood	New Jersey	United States	07631-4152
28	The Mount Sinai Hospital /ID# 233823	New York	New York	United States	10029
29	Lenox Hill Hospital /ID# 239312	New York	New York	United States	10075
30	New York Gastroenterology Associates /ID# 241967	New York	New York	United States	10075
31	Univ NC Chapel Hill /ID# 233557	Chapel Hill	North Carolina	United States	27514-4220
32	Northshore Gastroentrology Research LLC /ID# 239307	Brooklyn	Ohio	United States	44144
33	University of Cincinnati /ID# 234237	Cincinnati	Ohio	United States	45267-0585
34	Hightower Clinical /ID# 239598	Oklahoma City	Oklahoma	United States	73102
35	Digestive Disease Specialists /ID# 233825	Oklahoma City	Oklahoma	United States	73112
36	University of Pennsylvania /ID# 239291	Philadelphia	Pennsylvania	United States	19104-5502
37	llegheny Health Network Research Institute /ID# 239334	Pittsburgh	Pennsylvania	United States	15224
38	Gastroenterology Associates, P.A. of Greenville /ID# 233544	Greenville	South Carolina	United States	29615-3593
39	Gastro One /ID# 239748	Germantown	Tennessee	United States	38138
40	Southern Star Research Institute, LLC /ID# 240132	San Antonio	Texas	United States	78229-5390
41	Tyler Research Institute, LLC /ID# 233730	Tyler	Texas	United States	75701-4464
42	Gastro Health & Nutrition - Victoria /ID# 240158	Victoria	Texas	United States	77904
43	University of Utah Hospitals and Clinics /ID# 239264	Salt Lake City	Utah	United States	84132-0001
44	Verity Research, INC /ID# 240085	Fairfax	Virginia	United States	22031-4622
45	Hunter Holmes McGuire VA Medical Center /ID# 233759	Richmond	Virginia	United States	23249
46	Concord Repatriation General /ID# 233467	Concord	New South Wales	Australia	2139
47	Princess Alexandra Hospital /ID# 234243	Woolloongabba	Queensland	Australia	4102
48	Royal Adelaide Hospital /ID# 233705	Adelaide	South Australia	Australia	5000
49	The Queen Elizabeth Hospital /ID# 234242	Woodville South	South Australia	Australia	5011
50	Monash Medical Centre /ID# 233469	Clayton	Victoria	Australia	3168
51	Fiona Stanley Hospital /ID# 240136	Murdoch	Western Australia	Australia	6150
52	Medizinische Universitaet Innsbruck /ID# 234217	Innsbruck	Tirol	Austria	6020
53	Medizinische Universitaet Wien /ID# 234218	Vienna	Wien	Austria	1090
54	Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069	Salzburg		Austria	5020
55	UCL Saint-Luc /ID# 232435	Woluwe-Saint-Lambert	Bruxelles-Capitale	Belgium	1200
56	UZ Gent /ID# 246877	Gent	Oost-Vlaanderen	Belgium	9000
57	AZ Maria Middelares /ID# 246880	Gent		Belgium	9000
58	CHU de Liege /ID# 232436	Liege		Belgium	4000
59	AZ-Delta /ID# 232437	Roeselare		Belgium	8800
60	University Multiprofile Hospit /ID# 232468	Plovdiv		Bulgaria	4001
61	UMHAT Sveti Ivan Rilski /ID# 233522	Sofia		Bulgaria	1431
62	UMHAT Tsaritsa Joanna - ISUL /ID# 234135	Sofia		Bulgaria	1527
63	Acibadem City Clinic University Hospital EOOD /ID# 240003	Sofia		Bulgaria	1784
64	University of Calgary /ID# 233838	Calgary	Alberta	Canada	T2N 4Z6
65	Allen Whey Khye Lim Professional Corporation /ID# 233831	Edmonton	Alberta	Canada	T5R 1W2
66	Covenant Health /ID# 234277	Edmonton	Alberta	Canada	T6K 4B2
67	QE II Health Sciences Centre /ID# 233839	Halifax	Nova Scotia	Canada	B3H 1V7
68	London Health Sciences Center /ID# 234058	London	Ontario	Canada	N6A 5W9
69	Scott Shulman Medicine Professional Corporation /ID# 239567	North Bay	Ontario	Canada	P1B 2H3
70	Toronto Immune and Digestive Health Institute Inc /ID# 234142	North York	Ontario	Canada	M6A 3B4
71	Toronto Digestive Disease Asso /ID# 234143	Vaughan	Ontario	Canada	L4L 4Y7
72	Hepato-Gastroenterologie HK, s.r.o. /ID# 239965	Hradec Kralove		Czechia	500 12
73	ARTROSCAN s.r.o. /ID# 239882	Ostrava		Czechia	722 00
74	Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486	Prague 6		Czechia	162 00
75	Nemocnice Horovice - NH Hospital a.s /ID# 233915	Praha		Czechia	155 00
76	CHU Montpellier - Hôpital Saint Eloi /ID# 241136	Montpellier Cedex 5	Herault	France	34295
77	CHU de SAINT ETIENNE - Hopital Nord /ID# 234225	St. Priest En Jarez	Loire	France	42270
78	CHRU Nancy - Hôpitaux de Brabois /ID# 234224	Vandœuvre-lès-Nancy	Meurthe-et-Moselle	France	54500
79	AP-HP - Hopital Saint-Louis /ID# 234227	Paris		France	75010
80	Universitaetsklinikum Freiburg /ID# 233719	Freiburg	Baden-Wuerttemberg	Germany	79106
81	Universitatsklinikum Mannheim /ID# 233716	Mannheim	Baden-Wuerttemberg	Germany	68167
82	Universitaetsklinikum Ulm /ID# 233531	Ulm	Baden-Wuerttemberg	Germany	89081
83	Universitaetsklinikum Erlangen /ID# 233529	Erlangen	Bayern	Germany	91054
84	Universitatsklinik Regensburg /ID# 238702	Ratisbon	Bayern	Germany	93053
85	Universitaetsmedizin Essen /ID# 246354	Essen	Nordrhein-Westfalen	Germany	45147
86	Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527	Kiel	Schleswig-Holstein	Germany	24105
87	DRK Kliniken Berlin Westend /ID# 233718	Berlin		Germany	14050
88	Medizinische Hochschule Hannover /ID# 238804	Hannover		Germany	30625
89	EUGASTRO GmbH /ID# 233717	Leipzig		Germany	04103
90	Klinikum Lueneburg /ID# 233720	Lueneburg		Germany	21339
91	General Hospital of Athens Ippokratio /ID# 231655	Athens	Attiki	Greece	11527
92	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660	Athens	Attiki	Greece	11527
93	University General Hospital of Heraklion PA.G.N.I /ID# 231657	Heraklion	Kriti	Greece	71500
94	General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 231659	Pireaus		Greece	18454
95	Soroka University Medical Center /ID# 233458	Beer Sheva	HaDarom	Israel	8410101
96	The Chaim Sheba Medical Center /ID# 233457	Ramat Gan	Tel-Aviv	Israel	5265601
97	Tel Aviv Sourasky Medical Center /ID# 238525	Tel Aviv-Yafo	Tel-Aviv	Israel	6423906
98	The Edith Wolfson Medical Center /ID# 234042	Holon		Israel	5822000
99	Shaare Zedek Medical Center /ID# 233460	Jerusalem		Israel	91031
100	Hadassah Medical Center-Hebrew University /ID# 233518	Jerusalem		Israel	91120
101	Policlinico Agostino Gemelli /ID# 233380	Rome	Lazio	Italy	00168
102	ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386	Rho	Milano	Italy	20017
103	Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387	Bari		Italy	70124
104	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382	Milan		Italy	20122
105	Azienda Ospedaliera di Padova /ID# 233389	Padova		Italy	35128
106	Aichi Medical University Hospital /ID# 238528	Nagakute-shi	Aichi	Japan	480-1195
107	Nagoya City University Hospital /ID# 238368	Nagoya shi	Aichi	Japan	467-8602
108	Daido Clinic /ID# 239730	Nagoya-shi	Aichi	Japan	457-8511
109	Nagoya University Hospital /ID# 238662	Nagoya-shi	Aichi	Japan	4668560
110	Tsujinaka Hospital Kashiwanoha /ID# 239012	Kashiwa-shi	Chiba	Japan	277-0871
111	Fukushima Medical University Hospital /ID# 239314	Fukushima-shi	Fukushima	Japan	960-1295
112	Gunma University Hospital /ID# 239913	Maebashi-shi	Gunma	Japan	371-8511
113	Hiroshima University Hospital /ID# 238947	Hiroshima-shi	Hiroshima	Japan	734-8551
114	Asahikawa City Hospital /ID# 248061	Asahikawa-shi	Hokkaido	Japan	070-8610
115	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791	Sapporo-shi	Hokkaido	Japan	060-0033
116	Sapporo Medical University Hospital /ID# 239201	Sapporo-shi	Hokkaido	Japan	060-8543
117	Sapporo IBD Clinic /ID# 239054	Sapporo-shi	Hokkaido	Japan	064-0919
118	Hyogo College of Medicine College Hospital /Id# 239049	Nishinomiya-shi	Hyogo	Japan	663-8501
119	Kanazawa University Hospital /ID# 239670	Kanazawa-shi	Ishikawa	Japan	920-8641
120	Iwate Medical University Uchimaru Medical Center /ID# 238953	Morioka-shi	Iwate	Japan	020-8505
121	St. Marianna University Hospital /ID# 239167	Kawasaki-shi	Kanagawa	Japan	216-8511
122	University Hospital Kyoto Prefectural University of Medicine /ID# 239918	Kyoto-shi	Kyoto	Japan	602-8566
123	Mie University Hospital /ID# 239758	Tsu-shi	Mie	Japan	514-8507
124	Tohoku University Hospital /ID# 238476	Sendai-shi	Miyagi	Japan	9808574
125	Okayama University Hospital /ID# 239757	Okayama-shi	Okayama	Japan	700-8558
126	Osaka Metropolitan University Hospital /ID# 238638	Osaka-shi	Osaka	Japan	545-8586
127	Osaka University Hospital /ID# 240485	Suita-shi	Osaka	Japan	565-0871
128	Hamamatsu University Hospital /ID# 238527	Hamamatsu-shi	Shizuoka	Japan	431-3192
129	NHO Shizuoka Medical Center /ID# 239759	Sunto-gun	Shizuoka	Japan	411-8611
130	Tokyo Medical And Dental University Hospital /ID# 238950	Bunkyo-ku	Tokyo	Japan	113-8519
131	Kyorin University Hospital /ID# 239609	Mitaka-shi	Tokyo	Japan	181-8611
132	Tokyo Medical University Hospital /ID# 239668	Shinjuku-ku	Tokyo	Japan	160-0023
133	Center Hospital of the National Center for Global Health and Medicine /ID# 239792	Shinjuku-ku	Tokyo	Japan	162-8655
134	Tokyo Women's Medical University Hospital /ID# 239760	Shinjuku-ku	Tokyo	Japan	162-8666
135	Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554	Shinjuku-ku	Tokyo	Japan	169-0073
136	Yamagata University Hospital /ID# 239572	Yamagata-shi	Yamagata	Japan	990-9585
137	The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700	Daejeon		Korea, Republic of	34943
138	Asan Medical Center /ID# 233701	Seoul		Korea, Republic of	05505
139	Samsung Medical Center /ID# 233698	Seoul		Korea, Republic of	06351
140	Radboud Universitair Medisch Centrum /ID# 241292	Nijmegen	Gelderland	Netherlands	6525 GA
141	Academisch Medisch Centrum /ID# 232123	Amsterdam		Netherlands	1105 AZ
142	Wellington Regional Hospital /ID# 238326	Newtown	Wellington	New Zealand	6021
143	Hutt Hospital /ID# 238327	Lower Hutt		New Zealand	5010
144	Dunedin Hospital /ID# 238325	Otago		New Zealand	9016
145	Planetmed Sp. z o.o. /ID# 238447	Wroclaw	Dolnoslaskie	Poland	52-210
146	WIP Warsaw IBD Point Profesor Kierkus /ID# 233533	Warsaw	Mazowieckie	Poland	00-728
147	Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 238653	Warszawa	Mazowieckie	Poland	02-507
148	Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047	Guimaraes	Braga	Portugal	4835-044
149	CCA Braga - Hospital de Braga /ID# 249049	Braga		Portugal	4710-243
150	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 249046	Lisboa		Portugal	1649-035
151	Unidade Local de Saude do Alto Minho, EPE - Hospital de Santa Luzia /ID# 249087	Viana Do Castelo		Portugal	4900-408
152	Immanuel Kant Baltic Federal University /ID# 234165	Kaliningrad	Kaliningradskaya Oblast	Russian Federation	236016
153	LLC Medical Center /ID# 238774	Novosibirsk	Novosibirskaya Oblast	Russian Federation	630099
154	Perm Clinical Center of the Federal Medical and Biological Agency /ID# 234166	Perm	Permskiy Kray	Russian Federation	614109
155	First Moscow State Medical University n.a I.M. Sechenov /ID# 238773	Moscow		Russian Federation	119991
156	Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373	Banska Bystrica		Slovakia	975 17
157	ENDOMED s.r.o. /ID# 241855	Košice		Slovakia	040 01
158	KM Management, spol. s.r.o. /ID# 241849	Nitra		Slovakia	949 01
159	Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299	Ferrol	A Coruna	Spain	15405
160	Hospital Santa Creu i Sant Pau /ID# 232301	Barcelona		Spain	08041
161	Hospital Universitario La Paz /ID# 232300	Madrid		Spain	28046
162	Hospital Clinico Universitario de Valencia /ID# 234103	Valencia		Spain	46010
163	China Medical University Hospital /ID# 234132	Taichung City		Taiwan	40447
164	Taichung Veterans General Hospital /ID# 234131	Taichung		Taiwan	40705
165	National Taiwan University Hospital /ID# 234134	Taipei City		Taiwan	100
166	Royal Devon and Exeter NHS Trust Hospital /ID# 234194	Exeter	Devon	United Kingdom	EX2 5DW
167	University Hospital Southampton NHS Foundation Trust /ID# 238960	Southampton	Hampshire	United Kingdom	SO16 6YD
168	Barts Health NHS Trust /ID# 234188	London	London, City Of	United Kingdom	E1 2ES
169	Guys and St Thomas NHS Foundation Trust /ID# 234191	London	London, City Of	United Kingdom	SE1 9RT
170	NHS Greater Glasgow and Clyde /ID# 234186	Glasgow	Scotland	United Kingdom	G12 0XH
171	The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 234187	Newcastle Upon Tyne		United Kingdom	NE7 7DN
172	St George's University Hospitals NHS Foundation Trust /ID# 234193	Tooting		United Kingdom	SW17 0QT

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT05068284

Other Study ID Numbers:

M20-371
2021-002869-18

First Posted:

Oct 5, 2021

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by AbbVie

Crohn's Disease

ABBV-154

Additional relevant MeSH terms:

Crohn Disease

Study Results

No Results Posted as of Aug 23, 2022