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

NCT03107793

NCT03107793
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You have active, moderate to severe Crohn's disease affecting the small intestine and/or colon, confirmed by a symptom score and a camera examination (endoscopy) showing signs of active disease
  • Previous treatments for Crohn's disease either did not work well enough, stopped working, caused side effects you could not tolerate, or were not suitable for you — this applies to either standard (conventional) treatments or one previous biologic medication
  • You have been screened and cleared for tuberculosis (TB) infection
  • You are willing and able to sign a consent form agreeing to take part in the study

For the optional sub-study (in addition to the above):

  • You are already enrolled in the main study at a site that offers the sub-study
  • You are willing to sign a separate consent form for the sub-study
  • You meet all the main study requirements

Who may not be able to join:

  • You have serious complications from Crohn's disease, such as significant blockages in the bowel, short gut syndrome, or other issues that may require surgery or make it hard to measure how well treatment is working
  • You currently have, or are suspected to have, an abscess (a pocket of infection) — though recently drained skin or anal abscesses treated at least 3 weeks ago, or internal abscesses treated at least 8 weeks ago, may be acceptable (confirm with trial site)
  • You have had bowel surgery within the last 6 months
  • You have a working stoma or ostomy bag
  • You have already been treated with more than one biologic medication for Crohn's disease

For the optional sub-study:

  • Your body size or other physical characteristics make it unlikely that an abdominal ultrasound scan would give a clear picture of the affected bowel (confirm with trial site)
  • Your bowel wall appears normal in thickness on ultrasound at the start of the study

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-Cilag Ltd.
Registry
clinicaltrials_gov
Start date
19 April 2017
Est. completion
30 April 2020

Where this trial is recruiting

🇧🇪 Belgium 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇹 Portugal 🇸🇰 Slovakia 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom

Primary endpoints

Percentage of Participants With Endoscopic Response at Week 48

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