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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
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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
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Secondary ID [1]
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2021-002869-18
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Secondary ID [2]
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M20-371
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Universal Trial Number (UTN)
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Trial acronym
AIM-CD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
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0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
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Assessment method [1]
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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).
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Timepoint [1]
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Week 12 in the Induction Period
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Secondary outcome [1]
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Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI)
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Assessment method [1]
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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.
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Timepoint [1]
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Week 12 in the Induction Period
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Secondary outcome [2]
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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)
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Assessment method [2]
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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.
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Timepoint [2]
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Week 12 in the Induction Period
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Secondary outcome [3]
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Percentage of Participants Achieving Endoscopic Response per SES-CD
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Assessment method [3]
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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).
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Timepoint [3]
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Week 40 in the Maintenance Period
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Secondary outcome [4]
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Percentage of Participants Achieving Clinical Remission per CDAI
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Assessment method [4]
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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.
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Timepoint [4]
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Week 40 in the Maintenance Period
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Secondary outcome [5]
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Percentage of Participants Achieving Clinical Remission per SF/AP
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Assessment method [5]
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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.
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Timepoint [5]
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Week 40 in the Maintenance Period
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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.
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants with prior intolerance to adalimumab.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/07/2023
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Sample size
Target
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Accrual to date
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Final
176
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General /ID# 233467 - Concord
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Princess Alexandra Hospital /ID# 234243 - Woolloongabba
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Royal Adelaide Hospital /ID# 233705 - Adelaide
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The Queen Elizabeth Hospital /ID# 234242 - Woodville South
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Monash Medical Centre /ID# 233469 - Clayton
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Fiona Stanley Hospital /ID# 240136 - Murdoch
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2139 - Concord
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4102 - Woolloongabba
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5000 - Adelaide
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5011 - Woodville South
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3168 - Clayton
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6150 - Murdoch
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Name
AbbVie
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05068284
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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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/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05068284