Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05068284




Registration number
NCT05068284
Ethics application status
Date submitted
27/09/2021
Date registered
5/10/2021
Date last updated
3/10/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2021-002869-18
Secondary ID [2] 0 0
M20-371
Universal Trial Number (UTN)
Trial acronym
AIM-CD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-154
Treatment: Drugs - Placebo
Treatment: Drugs - ABBV-154
Treatment: Drugs - Placebo

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.


Treatment: Drugs: ABBV-154
Intravenous (IV) Infusion; Subcutaneous Injection

Treatment: Drugs: Placebo
Intravenous (IV) infusion; Subcutaneous Injection

Treatment: Drugs: ABBV-154
Subcutaneous Injection

Treatment: Drugs: Placebo
Subcutaneous Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI)
Timepoint [1] 0 0
Induction Period Week 12
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Induction Period Week 12
Secondary outcome [3] 0 0
Percentage of Participants Achieving Endoscopic Response Per SES-CD
Timepoint [3] 0 0
Week 40 in the Maintenance Period
Secondary outcome [4] 0 0
Percentage of Participants Achieving Clinical Remission Per CDAI
Timepoint [4] 0 0
Week 40 in the Maintenance Period
Secondary outcome [5] 0 0
Percentage of Participants Achieving Clinical Remission Per SF/AP
Timepoint [5] 0 0
Week 40 in the Maintenance Period

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with prior intolerance to adalimumab.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/07/2023
Sample size
Target
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General /ID# 233467 - Concord
Recruitment hospital [2] 0 0
Princess Alexandra Hospital /ID# 234243 - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital /ID# 233705 - Adelaide
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital /ID# 234242 - Woodville South
Recruitment hospital [5] 0 0
Monash Medical Centre /ID# 233469 - Clayton
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 240136 - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
Austria
State/province [24] 0 0
Tirol
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Austria
State/province [26] 0 0
Salzburg
Country [27] 0 0
Belgium
State/province [27] 0 0
Bruxelles-Capitale
Country [28] 0 0
Belgium
State/province [28] 0 0
Oost-Vlaanderen
Country [29] 0 0
Belgium
State/province [29] 0 0
West-Vlaanderen
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Liege
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Plovdiv
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Sofia
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
Nova Scotia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Czechia
State/province [37] 0 0
Hradec Kralove
Country [38] 0 0
Czechia
State/province [38] 0 0
Ostrava
Country [39] 0 0
Czechia
State/province [39] 0 0
Prague 6
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha
Country [41] 0 0
France
State/province [41] 0 0
Herault
Country [42] 0 0
France
State/province [42] 0 0
Loire
Country [43] 0 0
France
State/province [43] 0 0
Meurthe-et-Moselle
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
Germany
State/province [45] 0 0
Baden-Wuerttemberg
Country [46] 0 0
Germany
State/province [46] 0 0
Bayern
Country [47] 0 0
Germany
State/province [47] 0 0
Schleswig-Holstein
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Hannover
Country [50] 0 0
Germany
State/province [50] 0 0
Leipzig
Country [51] 0 0
Germany
State/province [51] 0 0
Lueneburg
Country [52] 0 0
Greece
State/province [52] 0 0
Attiki
Country [53] 0 0
Greece
State/province [53] 0 0
Kriti
Country [54] 0 0
Greece
State/province [54] 0 0
Pireaus
Country [55] 0 0
Hungary
State/province [55] 0 0
Szekszard
Country [56] 0 0
Israel
State/province [56] 0 0
HaDarom
Country [57] 0 0
Israel
State/province [57] 0 0
Tel-Aviv
Country [58] 0 0
Israel
State/province [58] 0 0
Yerushalayim
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Roma
Country [61] 0 0
Italy
State/province [61] 0 0
Bari
Country [62] 0 0
Italy
State/province [62] 0 0
Milan
Country [63] 0 0
Japan
State/province [63] 0 0
Aichi
Country [64] 0 0
Japan
State/province [64] 0 0
Chiba
Country [65] 0 0
Japan
State/province [65] 0 0
Fukushima
Country [66] 0 0
Japan
State/province [66] 0 0
Gunma
Country [67] 0 0
Japan
State/province [67] 0 0
Hiroshima
Country [68] 0 0
Japan
State/province [68] 0 0
Hokkaido
Country [69] 0 0
Japan
State/province [69] 0 0
Hyogo
Country [70] 0 0
Japan
State/province [70] 0 0
Ishikawa
Country [71] 0 0
Japan
State/province [71] 0 0
Iwate
Country [72] 0 0
Japan
State/province [72] 0 0
Kanagawa
Country [73] 0 0
Japan
State/province [73] 0 0
Kyoto
Country [74] 0 0
Japan
State/province [74] 0 0
Mie
Country [75] 0 0
Japan
State/province [75] 0 0
Miyagi
Country [76] 0 0
Japan
State/province [76] 0 0
Okayama
Country [77] 0 0
Japan
State/province [77] 0 0
Osaka
Country [78] 0 0
Japan
State/province [78] 0 0
Shizuoka
Country [79] 0 0
Japan
State/province [79] 0 0
Tokyo
Country [80] 0 0
Japan
State/province [80] 0 0
Yamagata
Country [81] 0 0
Korea, Republic of
State/province [81] 0 0
Daejeon
Country [82] 0 0
Korea, Republic of
State/province [82] 0 0
Seoul
Country [83] 0 0
Netherlands
State/province [83] 0 0
Gelderland
Country [84] 0 0
Netherlands
State/province [84] 0 0
Amsterdam
Country [85] 0 0
New Zealand
State/province [85] 0 0
Wellington
Country [86] 0 0
New Zealand
State/province [86] 0 0
Lower Hutt
Country [87] 0 0
New Zealand
State/province [87] 0 0
Otago
Country [88] 0 0
Poland
State/province [88] 0 0
Dolnoslaskie
Country [89] 0 0
Poland
State/province [89] 0 0
Mazowieckie
Country [90] 0 0
Poland
State/province [90] 0 0
Pomorskie
Country [91] 0 0
Portugal
State/province [91] 0 0
Braga
Country [92] 0 0
Puerto Rico
State/province [92] 0 0
San Juan
Country [93] 0 0
Slovakia
State/province [93] 0 0
Banska Bystrica
Country [94] 0 0
Slovakia
State/province [94] 0 0
Košice
Country [95] 0 0
Slovakia
State/province [95] 0 0
Nitra
Country [96] 0 0
Spain
State/province [96] 0 0
A Coruna
Country [97] 0 0
Spain
State/province [97] 0 0
Barcelona
Country [98] 0 0
Spain
State/province [98] 0 0
Madrid
Country [99] 0 0
Spain
State/province [99] 0 0
Valencia
Country [100] 0 0
Taiwan
State/province [100] 0 0
Taichung
Country [101] 0 0
Taiwan
State/province [101] 0 0
Taipei City
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Devon
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Hampshire
Country [104] 0 0
United Kingdom
State/province [104] 0 0
London, City Of
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Scotland
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Tooting

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05068284
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05068284