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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

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
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05068284