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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01369329

NCT01369329
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Crohn's disease for at least 3 months, affecting your colon, small intestine, or both, confirmed at some point by imaging, tissue testing, or a camera examination of the gut.
  • Your Crohn's disease is currently active, based on a specific scoring system that measures disease activity (confirm with trial site for exact score requirements).
  • You have previously tried one of these medications for Crohn's disease — infliximab, adalimumab, or certolizumab pegol — at the standard approved dose, and it never worked for you in the first place.
  • Or you tried one of those medications and it worked at first but then stopped working over time.
  • Or you tried one of those medications but had to stop because you could not tolerate it.
  • Your recent blood or lab test results fall within the ranges required by the study.

Who may not be able to join:

  • You have had any type of bowel surgery within the last 6 months.
  • You are pregnant, planning to become pregnant, or (if male) planning to father a child while in the study or within 20 weeks after receiving the study treatment.
  • You received infliximab, adalimumab, or certolizumab pegol within 8 weeks before the study drug would first be given to you.
  • You have certain serious complications from Crohn's disease that would make it difficult to measure how well the study drug is working (confirm with trial site for specifics).
  • You have a history of, or currently have, a long-term or repeatedly occurring infectious disease.
  • You have previously received a biologic medication that targets specific parts of the immune system known as IL-12 or IL-23, such as ustekinumab or briakinumab.

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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Janssen Research & Development, LLC
Registry
clinicaltrials_gov
Start date
1 July 2011
Est. completion
1 June 2013

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary Iceland 🇮🇪 Ireland 🇮🇱 Israel 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇸 Serbia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of Participants With Clinical Response at Week 6

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov