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

NCT03440385

NCT03440385
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, confirmed by a camera examination of the gut (endoscopy) and tissue sample (biopsy)
  • Previous treatments have not worked well enough for you, or have stopped working — including steroids, immune-suppressing medicines, and/or biologic medicines
  • Your Crohn's disease activity falls within a specific moderate-to-severe range, measured by a standard scoring system called the CDAI (confirm with trial site)
  • You are experiencing on average 4 or more loose stools per day and/or significant abdominal pain on a daily basis
  • A camera examination of your gut shows a certain level of inflammation, measured by a scoring system called the SES-CD (confirm with trial site)

Who may not be able to join:

  • You have been diagnosed with a different type of bowel condition, such as ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or you have a narrowing in your bowel that needs a procedure to treat it
  • You have had a large portion of your small bowel removed (more than 100cm), have a condition called short bowel syndrome, or need to receive all your nutrition through a drip into a vein
  • You currently have a stoma bag, a surgically created internal pouch, or an abnormal tunnel (fistula) in or around your bowel
  • There may be additional criteria not listed here that could affect your eligibility (confirm with trial site)

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
Celgene
Registry
clinicaltrials_gov
Start date
7 March 2018
Est. completion
21 November 2023

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇴 Colombia 🇫🇮 Finland 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇱🇹 Lithuania 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia Senegal 🇷🇸 Serbia 🇸🇰 Slovakia 🇸🇮 Slovenia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇺🇸 United States

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

Primary endpoints

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Score < 150

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