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

NCT03345849

NCT03345849
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 (CD) for at least 3 months before the study starts.
  • Your Crohn's disease has been confirmed as moderate to severe, based on how often you have bowel movements and your level of abdominal pain.
  • A camera test (endoscopy) has shown active inflammation in your gut, confirmed by an independent reviewer.
  • Previous treatments for Crohn's disease — such as steroids, immune-suppressing medicines, or biologic therapies — have not worked well enough for you, or you were unable to tolerate them.
  • If you previously tried a biologic therapy but stopped it for a reason other than it not working or causing side effects (for example, insurance changes or because your disease was under control), you may still be eligible (confirm with trial site).
  • If you are a woman who could become pregnant, you must be willing to follow the trial's contraception requirements.

Who may not be able to join:

  • You have been diagnosed with ulcerative colitis or a form of colitis that doctors have not been able to clearly classify.
  • You are not currently on a stable, consistent dose of certain Crohn's-related medicines, such as antibiotics, aminosalicylates, steroids, or methotrexate.
  • You currently have serious complications from Crohn's disease, such as an abscess, a blocked bowel, severe colitis, a dangerously swollen colon, large sections of your bowel missing, or any condition that may require surgery during the study.
  • You have had a stoma (ostomy bag) or a surgically created internal pouch.
  • You have a condition that affects how your body absorbs medicine, such as short bowel syndrome.
  • Your blood tests or other screening results come back with abnormal findings (confirm with trial site for specific details).

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
AbbVie
Registry
clinicaltrials_gov
Start date
7 December 2017
Est. completion
15 October 2021

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium Bosnia and Herzegovina 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇬 Egypt 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal Puerto Rico 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇸🇬 Singapore 🇸🇰 Slovakia 🇸🇮 Slovenia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12; Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12; Percentage of Participants With Endoscopic Response at Week 12

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