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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 (AIM-CD)

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ClinicalTrials.gov Identifier: NCT05068284
Recruitment Status : Recruiting
First Posted : October 5, 2021
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 31, 2022
Estimated Primary Completion Date : January 2, 2024
Estimated Study Completion Date : July 4, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD) [ Time Frame: 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 :
  1. Percentage of Participants Achieving Clinical Remission per Crohn's Disease Activity Index (CDAI) [ Time Frame: 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.

  2. 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) [ Time Frame: 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.

  3. Percentage of Participants Achieving Endoscopic Response per SES-CD [ Time Frame: 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).

  4. Percentage of Participants Achieving Clinical Remission per CDAI [ Time Frame: 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.

  5. Percentage of Participants Achieving Clinical Remission per SF/AP [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

- Participants with prior intolerance to adalimumab.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068284


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05068284    
Other Study ID Numbers: M20-371
2021-002869-18 ( EudraCT Number )
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria: 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/
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AbbVie:
Crohn's Disease
ABBV-154
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases