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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

AIM-CD Trial Summary

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

Eligible Conditions
  • Crohn's Disease

AIM-CD Trial 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

AIM-CD 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
954 Previous Clinical Trials
500,929 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,763 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safety precautions have been taken with regard to ABBV-154?

"ABBV-154 is currently being assessed for safety in Phase 2 trials, meaning there are several rounds of data confirming its level of risk. Consequently, Power has rated ABBV-154's security as a 2 on a scale from 1 to 3."

Answered by AI

Am I a suitable candidate to participate in this experiment?

"This trial is seeking 265 individuals aged 18 to 75 with a confirmed diagnosis of ileocolitis. In addition, applicants must satisfy the following: Possess Crohn's disease (CD) for at least 3 months before Baseline of Induction Period., Have CDAI score of 220 to 450 at beginning of Induction Phase., Exhibit endoscopic evidence of mucosal inflammation through SES-CD >=6 if suffering from colonic or ileal colonic diseases and SES-CD >=4 for isolated ileal conditions as examined by an unbiased observer., Displayed inefficacy towards biologic agents such as inflixim"

Answered by AI

Does this research endeavor admit individuals who are 40 years or older?

"The prerequisites for enrolment in this research indicates that participants must be between 18 and 75 years of age. For those below the age of consent, there are 69 studies available; conversely, 194 studies cater to adults above 65."

Answered by AI

Is enrollment still available for this trial?

"According to the latest figures from clinicaltrials.gov, this research project is actively recruiting volunteers. The trial was originally published on January 31st 2022 and last updated on November 21st of that same year."

Answered by AI

What is the geographical scope of this experiment?

"Currently, there are 70 trial sites participating in this research. A few of the most notable ones include University of Utah Hospitals and Clinics (ID# 239264) located in Salt Lake City, GI Specialists of GA PC (ID#239261) situated in Marietta, Georgia and Allegheny Health Network Research Institute (ID #239334) based out of Pittsburgh, Pennsylvania."

Answered by AI

How many participants are currently taking part in the research?

"265 eligible patients must join this study. Participation is available in University of Utah Hospitals and Clinics (ID# 239264) located Salt Lake City, UT or GI Specialists of GA, PC /ID# 239261 situated in Marietta, GA."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
~56 spots leftby Apr 2025