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Monoclonal Antibodies

ABBV-154 for 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
Awards & highlights

Summary

This trial is evaluating the safety and effectiveness of ABBV-154 in people with Crohn's disease.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Secondary outcome measures
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
983 Previous Clinical Trials
509,185 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
414 Previous Clinical Trials
151,716 Total Patients Enrolled
~52 spots leftby Jul 2025