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

NCT01355614

NCT01355614
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have at least one fistula (an abnormal tunnel) between your bowel and skin near your bottom that is actively draining
  • You have been officially diagnosed with Crohn's disease for at least 6 months
  • You have already tried at least one treatment for your fistula that did not work
  • You have not previously tried a type of medication called anti-TNF antibody therapy (such as infliximab or adalimumab) that failed to help you
  • You are in generally good health with no other serious conditions that could affect your ability to take part safely

Who may not be able to join:

  • You are currently using, or have recently used (within the last 30 days, or longer depending on the medication), anti-TNF antibody treatments
  • Your Crohn's disease is currently active and flaring
  • You have recently had, or are about to have, surgery on your abdomen or back passage, or you have a narrowing, abscess, or blockage that may require surgery
  • You have previously tried anti-TNF antibody therapy and it did not work for you
  • You currently have a confirmed bacterial or viral infection, including in your gut

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 2: approximately ~30% 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 2
Sponsor
Novartis Pharmaceuticals
Registry
clinicaltrials_gov
Start date
1 June 2011
Est. completion
1 March 2013

Where this trial is recruiting

🇩🇪 Germany 🇨🇭 Switzerland

Primary endpoints

Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation

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