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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT05068284

Run by

AbbVie

People needed

176

Starts

2022-01-31

Expected to finish

2023-07-20

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to Baseline of the Induction Period.
• Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction Period.
• Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component.
• Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or risankizumab.

You may not qualify if…

• Participants with prior intolerance to adalimumab.

Where it is running

• East View Medical Research, LLC /ID# 240030 — Mobile, Alabama, United States
• Southern California Res. Ctr. /ID# 233512 — Coronado, California, United States
• Hoag Memorial Hosp Presbyterian /ID# 233555 — Irvine, California, United States
• University of Colorado Hospital /ID# 239361 — Aurora, Colorado, United States
• Medical Research Center of CT /ID# 233542 — Hamden, Connecticut, United States
• Atlantic Medical Research /ID# 233506 — Margate, Florida, United States
• University of Miami /ID# 233811 — Miami, Florida, United States
• Gastroenterology Group Naples /ID# 233829 — Naples, Florida, United States
• Digestive Disease Consultants - Orange Park /ID# 241015 — Orange Park, Florida, United States
• Endoscopic Research, Inc. /ID# 234279 — Orlando, Florida, United States
• IMIC Inc. Medical Research /ID# 233821 — Palmetto Bay, Florida, United States
• Emory University /ID# 241014 — Atlanta, Georgia, United States
• AGILE Clinical Research Trials /ID# 233739 — Atlanta, Georgia, United States
• Gastroenterology Associates of Central Georgia, LLC /ID# 245604 — Macon, Georgia, United States
• GI Specialists of GA, PC /ID# 239261 — Marietta, Georgia, United States
• Gastroenterology Consultants, P.C /ID# 233552 — Roswell, Georgia, United States
• The University of Chicago DCAM /ID# 233824 — Chicago, Illinois, United States
• Digestive Health Services /ID# 241177 — Downers Grove, Illinois, United States
• Southwest Gastroenterology /ID# 234278 — Oak Lawn, Illinois, United States
• University of Louisville /ID# 233766 — Louisville, Kentucky, United States
• Louisiana Research Center, LLC /ID# 245370 — Shreveport, Louisiana, United States
• University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765 — Ann Arbor, Michigan, United States
• Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763 — Wyoming, Michigan, United States
• Mayo Clinic - Rochester /ID# 238516 — Rochester, Minnesota, United States
• Digestive Health Specialists of the Southeast /ID# 239599 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.