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Monoclonal Antibodies

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 Trial)

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 40 in the maintenance period

Summary

This trial is testing ABBV-154, a new drug for adults with moderate to severe Crohn's disease. The drug aims to reduce gut inflammation by calming the immune response. The study will check its safety and effectiveness through medical assessments over time.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 40 in the maintenance period
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 40 in the maintenance period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Secondary study objectives
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)
Percentage of Participants Achieving Clinical Remission Per CDAI
Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI)
+2 more

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Re-Induction Phase: ABBV-154 Randomized Dose BExperimental Treatment1 Intervention
Varying doses of ABBV-154 as described in the protocol.
Group II: Re-Induction Phase: ABBV-154 Randomized Dose AExperimental Treatment1 Intervention
Varying doses of ABBV-154 as described in the protocol.
Group III: Maintenance Phase: ABBV-154 Randomized Dose BExperimental Treatment1 Intervention
Fixed dose ABBV-154 every other week.
Group IV: Maintenance Phase: ABBV-154 Randomized Dose AExperimental Treatment1 Intervention
Fixed dose ABBV-154 every other week.
Group V: Induction Phase: ABBV-154 Randomized Dose DExperimental Treatment2 Interventions
Varying doses of ABBV-154 as described in the protocol.
Group VI: Induction Phase: ABBV-154 Randomized Dose CExperimental Treatment1 Intervention
Varying doses of ABBV-154 as described in the protocol.
Group VII: Induction Phase: ABBV-154 Randomized Dose BExperimental Treatment1 Intervention
Varying doses of ABBV-154 as described in the protocol.
Group VIII: Induction Phase: ABBV-154 Randomized Dose AExperimental Treatment1 Intervention
Varying doses of ABBV-154 as described in the protocol.
Group IX: Maintenance Phase: Randomized PlaceboPlacebo Group1 Intervention
Fixed dose placebo every other week.
Group X: Induction Phase: Randomized PlaceboPlacebo Group1 Intervention
Fixed dose placebo as described in the protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,868 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
456 Previous Clinical Trials
163,517 Total Patients Enrolled
~46 spots leftby Dec 2025
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