ABBV-154 for Ileocolitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
New York Gastroenterology Associates /ID# 241967, New York, NY
Ileocolitis+1 More
ABBV-154 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is evaluating the safety and effectiveness of ABBV-154 in people with Crohn's disease. ABBV-154 is used to treat Ileocolitis, a condition that causes inflammation of the colon. This is the second time ABBV-154 has been approved by the FDA, as it was previously approved for a different condition.

Eligible Conditions

  • Ileocolitis
  • Crohn Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Ileocolitis

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Week 40 in the Maintenance Period

Week 12
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 Crohn's Disease Activity Index (CDAI)
Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
Week 40
Percentage of Participants Achieving Clinical Remission per CDAI
Percentage of Participants Achieving Clinical Remission per SF/AP
Percentage of Participants Achieving Clinical Remission per SF/SP
Percentage of Participants Achieving Endoscopic Response per SES-CD

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Ileocolitis

Trial Design

10 Treatment Groups

Re-Induction Phase: ABBV-154 Randomized Dose A
1 of 10
Maintenance Phase: ABBV-154 Randomized Dose B
1 of 10
Induction Phase: ABBV-154 Randomized Dose A
1 of 10
Induction Phase: ABBV-154 Randomized Dose D
1 of 10
Induction Phase: ABBV-154 Randomized Dose C
1 of 10
Maintenance Phase: ABBV-154 Randomized Dose A
1 of 10
Induction Phase: ABBV-154 Randomized Dose B
1 of 10
Re-Induction Phase: ABBV-154 Randomized Dose B
1 of 10
Induction Phase: Randomized Placebo
1 of 10
Maintenance Phase: Randomized Placebo
1 of 10
Experimental Treatment
Non-Treatment Group

265 Total Participants · 10 Treatment Groups

Primary Treatment: ABBV-154 · Has Placebo Group · Phase 2

Re-Induction Phase: ABBV-154 Randomized Dose A
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Maintenance Phase: ABBV-154 Randomized Dose B
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Induction Phase: ABBV-154 Randomized Dose A
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Induction Phase: ABBV-154 Randomized Dose DExperimental Group · 2 Interventions: Placebo, ABBV-154 · Intervention Types: Drug, Drug
Induction Phase: ABBV-154 Randomized Dose C
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Maintenance Phase: ABBV-154 Randomized Dose A
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Induction Phase: ABBV-154 Randomized Dose B
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Re-Induction Phase: ABBV-154 Randomized Dose B
Drug
Experimental Group · 1 Intervention: ABBV-154 · Intervention Types: Drug
Induction Phase: Randomized Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Maintenance Phase: Randomized Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 40 in the maintenance period
Closest Location: New York Gastroenterology Associates /ID# 241967 · New York, NY
Photo of New York 1Photo of New York 2Photo of New York 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Ileocolitis
0 CompletedClinical Trials

Who is running the clinical trial?

AbbVieLead Sponsor
803 Previous Clinical Trials
462,797 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
281 Previous Clinical Trials
112,084 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.