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
Public ClinicalTrials.gov record NCT05068284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 comprised 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.
Study identification
- NCT ID
- NCT05068284
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 176 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2022 (Actual)
- Primary completion
- Jul 20, 2023 (Actual)
- Completion
- Jul 20, 2023 (Actual)
- Last update posted
- Oct 3, 2024
2022 – 2023
United States locations
- U.S. sites
- 45
- U.S. states
- 23
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast /ID# 239599 | Dothan | Alabama | 36305 | — |
| East View Medical Research, LLC /ID# 240030 | Mobile | Alabama | 36606 | — |
| Southern California Res. Ctr. /ID# 233512 | Coronado | California | 92118-1408 | — |
| Hoag Memorial Hosp Presbyterian /ID# 233555 | Irvine | California | 92618 | — |
| University of Colorado Hospital /ID# 239361 | Aurora | Colorado | 80045 | — |
| Medical Research Center of CT /ID# 233542 | Hamden | Connecticut | 06518 | — |
| Atlantic Medical Research /ID# 233506 | Margate | Florida | 33063-5737 | — |
| University of Miami /ID# 233811 | Miami | Florida | 33136 | — |
| Gastroenterology Group Naples /ID# 233829 | Naples | Florida | 34102 | — |
| Digestive Disease Consultants - Orange Park /ID# 241015 | Orange Park | Florida | 32073 | — |
| Endoscopic Research, Inc. /ID# 234279 | Orlando | Florida | 32803 | — |
| IMIC Inc. Medical Research /ID# 233821 | Palmetto Bay | Florida | 33157 | — |
| Emory University /ID# 241014 | Atlanta | Georgia | 30322-1013 | — |
| AGILE Clinical Research Trials /ID# 233739 | Atlanta | Georgia | 30328-5532 | — |
| Gastroenterology Associates of Central Georgia, LLC /ID# 245604 | Macon | Georgia | 31201 | — |
| GI Specialists of GA, PC /ID# 239261 | Marietta | Georgia | 30060 | — |
| Gastroenterology Consultants, P.C /ID# 233552 | Roswell | Georgia | 30076-4913 | — |
| The University of Chicago DCAM /ID# 233824 | Chicago | Illinois | 60637 | — |
| Digestive Health Services /ID# 241177 | Downers Grove | Illinois | 60515-1552 | — |
| Southwest Gastroenterology /ID# 234278 | Oak Lawn | Illinois | 60453 | — |
| University of Louisville /ID# 233766 | Louisville | Kentucky | 40202 | — |
| Louisiana Research Center, LLC /ID# 245370 | Shreveport | Louisiana | 71105-6800 | — |
| University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765 | Ann Arbor | Michigan | 48109 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763 | Wyoming | Michigan | 49519 | — |
| Mayo Clinic - Rochester /ID# 238516 | Rochester | Minnesota | 55905-0001 | — |
| Las Vegas Medical Research /ID# 233826 | Las Vegas | Nevada | 89113 | — |
| Allied Health Clinical Research Organization, LLC /ID# 241935 | Englewood | New Jersey | 07631-4152 | — |
| The Mount Sinai Hospital /ID# 233823 | New York | New York | 10029 | — |
| Lenox Hill Hospital /ID# 239312 | New York | New York | 10075 | — |
| New York Gastroenterology Associates /ID# 241967 | New York | New York | 10075 | — |
| Univ NC Chapel Hill /ID# 233557 | Chapel Hill | North Carolina | 27514-4220 | — |
| Northshore Gastroentrology Research LLC /ID# 239307 | Brooklyn | Ohio | 44144 | — |
| University of Cincinnati /ID# 234237 | Cincinnati | Ohio | 45267-0585 | — |
| Hightower Clinical /ID# 239598 | Oklahoma City | Oklahoma | 73102 | — |
| Digestive Disease Specialists /ID# 233825 | Oklahoma City | Oklahoma | 73112 | — |
| University of Pennsylvania /ID# 239291 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Allegheny Health Network Research Institute /ID# 239334 | Pittsburgh | Pennsylvania | 15224 | — |
| Gastroenterology Associates, P.A. of Greenville /ID# 233544 | Greenville | South Carolina | 29607 | — |
| Gastro One /ID# 239748 | Cordova | Tennessee | 38018 | — |
| Southern Star Research Institute, LLC /ID# 240132 | San Antonio | Texas | 78229-5390 | — |
| Tyler Research Institute, LLC /ID# 233730 | Tyler | Texas | 75701-4464 | — |
| Gastro Health & Nutrition - Victoria /ID# 240158 | Victoria | Texas | 77904 | — |
| University of Utah Hospitals and Clinics /ID# 239264 | Salt Lake City | Utah | 84132-0001 | — |
| Gastro Health Research /ID# 240085 | Fairfax | Virginia | 22031-4622 | — |
| Hunter Holmes McGuire VA Medical Center /ID# 233759 | Richmond | Virginia | 23249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 121 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05068284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 3, 2024 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05068284 live on ClinicalTrials.gov.