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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05068284




Registration number
NCT05068284
Ethics application status
Date submitted
27/09/2021
Date registered
5/10/2021
Date last updated
1/08/2023

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
Week 12 in the Induction Period
Secondary outcome [1] 0 0
Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI)
Timepoint [1] 0 0
Week 12 in the Induction Period
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
Week 12 in the Induction Period
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
Terminated
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
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Alabama
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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 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.
Trial website
https://clinicaltrials.gov/ct2/show/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/ct2/show/NCT05068284