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NCT03635112

NCT03635112
Terminated Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are at least 18 years old at the time of screening
  • You are male or female and have been diagnosed with Crohn's disease for at least 3 months before screening
  • Your Crohn's disease is considered moderately to severely active, based on a specific scoring system used by doctors (called the CDAI, with a score between 220 and 450)
  • A camera examination of your bowel shows a certain level of ulceration (open sores) in at least one section of your intestine, confirmed by a specific scoring tool (confirm with trial site)
  • You either depend on steroid medication to manage your symptoms, or previous treatments have not worked well enough or caused you problems — this includes common Crohn's treatments and/or biological medicines

Who may not be able to join:

  • You are currently being treated with a type of biological medicine (such as anti-TNF, anti-integrin, or anti-IL-12/23 therapies)
  • You currently have an active infection caused by bacteria, parasites, fungi, or a virus
  • Your recent blood or lab test results show significant abnormalities (confirm with trial site)
  • You have previously taken, or may have been exposed to, a type of medicine called a JAK inhibitor that was stopped because it did not work or caused side effects
  • You have taken part in another clinical trial involving an experimental drug or device within the past 30 days (or longer, depending on the drug), or you are currently in another such trial
  • You have already tried and not responded to 3 or more different types of biological medicines, each working in a different way

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
Terminated
Phase
Phase 2
Sponsor
Theravance Biopharma
Registry
clinicaltrials_gov
Start date
19 November 2018
Est. completion
30 December 2021

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇭🇷 Croatia 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇳🇿 New Zealand 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Change From Baseline in Crohn's Disease Activity Index (CDAI) Score

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