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NCT04173273

NCT04173273
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are a man or woman between 18 and 80 years old
  • You are able to give written consent and are able to follow the schedule of visits and assessments required by the trial
  • You have been diagnosed with Crohn's disease for at least 3 months
  • Your Crohn's disease is considered moderately to severely active at the time of screening
  • You have tried at least one of the following treatments and either did not respond to it, stopped responding over time, or could not tolerate it: steroid tablets (such as prednisone or budesonide), immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate), or certain biologic injection/infusion treatments (such as infliximab, adalimumab, certolizumab, vedolizumab, or ustekinumab)
  • If you are a woman who could become pregnant, you must not currently be pregnant
  • If you are a woman who could become pregnant, or a man, you must agree to use contraception during the trial
  • For Substudy 3: You must have previously participated in and completed a specific visit during the extended induction period of Substudy 1 or Substudy 2 (confirm with trial site)
  • For Substudy 4: You must have completed a specific week 52 or week 66 visit in an earlier part of the trial (confirm with trial site)

Who may not be able to join:

  • You have not responded to two or more different classes of biologic treatments (such as TNF-blockers, interleukin blockers, or integrin blockers) for Crohn's disease
  • You have another type of bowel condition, such as ulcerative colitis, microscopic colitis, ischemic colitis, toxic megacolon, or an active bowel infection, or you test positive for a bacteria called Clostridioides difficile at screening
  • You have short bowel syndrome or related complications that may need surgery or affect how the trial measures results
  • You had surgery to treat an abscess inside your abdomen within the last 8 weeks, or surgery for an abscess near your back passage within the last 4 weeks
  • You had a portion of your intestine removed within the last 24 weeks, or any other abdominal surgery within the last 12 weeks
  • You have a stoma bag (ileostomy or colostomy)

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
Terminated
Phase
Phase 3
Sponsor
Pfizer
Registry
clinicaltrials_gov
Start date
6 January 2020
Est. completion
23 April 2025

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria Belarus 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇬 Egypt 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇱🇧 Lebanon 🇱🇹 Lithuania 🇲🇾 Malaysia 🇲🇽 Mexico Moldova 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Proportion of Participants with Endoscopic Response [Substudy A]; Proportion of Participants With Endoscopic Response [Substudy 1]; Proportion of Participants With Endoscopic Response [Substudy 2]; Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]; Proportion of Participants With Clinical Remission CDAI [Substudy 3]; Proportion of Participants With Endoscopic Response [Substudy 3]

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