Phase 2 Crohn's Disease and Colitis Trial, Terminated NCT05068284 Sponsor: AbbVie Condition: Crohn's Disease and Colitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called ABBV-154 in people with Crohn's disease. The trial involved different groups receiving either a placebo (a dummy treatment with no active ingredient) or ABBV-154 at various doses and delivery methods — some given by drip into a vein (IV) followed by injections under the skin (SC), and at different timing intervals. In total, across all groups and study phases, around 106 people were enrolled. The trial ran in several stages: a 12-week induction phase (initial treatment period), a 12-week re-induction phase for some participants, and a 40-week maintenance phase. The main thing being measured was how many participants showed a meaningful improvement in the appearance of their bowel lining on a camera examination (called an endoscopic response), using a scoring system known as the SES-CD. The reported data shows that for the primary outcome — endoscopic response at 12 weeks — 0 out of 21 participants in the placebo group met the threshold, compared with 1 out of 20 in the lowest ABBV-154 IV/SC dose group, 4 out of 22 in the mid-dose group, 4 out of 20 in the higher every-two-week dose group, and 3 out of 23 in the higher every-four-week dose group. For the secondary outcomes measuring symptom-based remission (using two different scoring tools — the CDAI and the SF/AP criteria), the reported numbers were similarly small across all groups. For example, on the CDAI remission measure, the numbers ranged from 2 participants in the placebo group up to 6 in the mid-dose group. Several secondary outcome measures relating to the maintenance phase were listed but had no data reported, so those results are not available. It is worth noting that the numbers of participants in this trial were quite small across all groups, which is typical of an early-phase trial designed to explore dosing and gather initial data rather than draw firm conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Crohn's Disease and Colitis Trial, Terminated

NCT05068284
Terminated Phase 2 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You have been diagnosed with Crohn's Disease for at least 3 months before the study starts.
  • Your Crohn's Disease activity falls within a certain range of severity, based on a standard scoring system called the CDAI (with a score between 220 and 450), meaning your disease is moderately to severely active.
  • A camera examination of your gut (endoscopy) has shown active inflammation in your intestines, reaching a specific minimum score depending on which part of your gut is affected (confirm with trial site for exact score details).
  • You have either not responded well enough to, or could not tolerate, at least one of the following medications: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or risankizumab.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have previously had a bad reaction to or could not tolerate the medication adalimumab.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

Trial contact details on record

Principal Investigator: ABBVIE INC., AbbVie

Australian sites

Concord Repatriation General /ID# 233467, Concord, New South Wales
Princess Alexandra Hospital /ID# 234243, Woolloongabba, Queensland
Royal Adelaide Hospital /ID# 233705, Adelaide, South Australia
The Queen Elizabeth Hospital /ID# 234242, Woodville South, South Australia
Monash Medical Centre /ID# 233469, Clayton, Victoria
Fiona Stanley Hospital /ID# 240136, Murdoch, Western Australia

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
31 January 2022
Est. completion
20 July 2023

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 6 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov