Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06548542 Sponsor: AbbVie Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06548542
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • People who weigh at least 40 kg (about 88 pounds) at the start of the trial.
  • People who have been diagnosed with Crohn's disease for at least 3 months before the trial starts, with biopsy results available to confirm the diagnosis.
  • People whose Crohn's disease is considered active enough at the start of the trial, based on a standard scoring system called the CDAI (a score of 220 or higher is required).
  • People who have signs of inflammation in the gut lining, confirmed by a camera examination of the bowel, meeting specific score thresholds depending on which part of the bowel is affected (confirm with trial site for exact score details).
  • People who have either not responded well enough to standard Crohn's disease treatments, or who could not tolerate them — including biologics and/or targeted small molecule medicines.

Who may not be able to join:

  • People who have previously had a bad reaction or intolerance to a specific type of medicine called a "p19 inhibitor," which includes a drug called risankizumab.
  • People who have recently taken certain investigational or newly approved targeted treatments within the past 30 days or within 5 "half-lives" of the drug (whichever is the longer period), unless blood tests show no detectable levels of the drug remain.
  • People currently diagnosed with a different bowel condition called ulcerative colitis or indeterminate colitis.
  • People who currently have a stoma (ostomy bag) or an ileoanal pouch.
  • People who currently have short bowel syndrome (where a large portion of the bowel is missing or not working).
  • People who have had surgical bowel removal within the 3 months before the trial starts.

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 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: ABBVIE INC., AbbVie

Phone: 844-663-3742

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
4 September 2024
Est. completion
1 January 2030

Where this trial is recruiting

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇸 Serbia 🇸🇬 Singapore 🇸🇰 Slovakia 🇸🇮 Slovenia 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Percentage of Participants who Achieve Endoscopic Remission; Number of Participants with Adverse Events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 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