Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03155932) enrolled 2 participants who were given a study drug called APD334 (also known as etrasimod). The trial was designed to look at two main things: changes in a blood marker called alkaline phosphatase (ALP) — a substance that, when elevated, can suggest a liver condition is progressing — and the number of participants who experienced any unwanted or unexpected health events (called adverse events) during the study. Both participants started the trial, both moved on to a higher dose at the 12-week mark, and both completed the study. The reported data shows that for the ALP blood marker measurements — one of the primary things the trial set out to measure — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For the second primary measure, the reported data shows that 2 out of 2 participants experienced at least one adverse event. No numbers were reported for the secondary outcomes, which included further ALP measurements and an assessment of how the drug moved through the body (known as pharmacokinetics). The exploratory outcomes, such as changes in blood counts and fatigue levels, also had no data reported. It is worth noting that with only 2 participants, this was an extremely small study, and the absence of many reported numbers means there is very limited information available from this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Primary Biliary Cholangitis Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 80 years old (inclusive)
- You have been diagnosed with Primary Biliary Cholangitis (PBC), confirmed by at least 2 of the following: a specific blood test showing certain antibodies, a liver enzyme (ALP) that has been above a certain level for at least 6 months, or a liver biopsy that shows signs of PBC
- You have been taking a medication called ursodeoxycholic acid (UDCA) for at least 6 months, with the same dose for at least the last 3 months
- Your liver-related blood test results fall within specific ranges — your ALP is above a certain level but not extremely high, two other liver enzymes (ALT and AST) are not too elevated, and your bilirubin is within the normal range
- Your liver blood test results have been stable (within 20% of each other) across two measurements taken at least 4 weeks apart
Who may not be able to join:
- You have a chronic liver disease that is caused by something other than PBC (note: having PBC alongside a condition called primary Sjögren's syndrome is still allowed)
- You have a history of serious liver failure or significant liver complications
- You have a medical condition unrelated to the liver that causes a certain enzyme (ALP) to be raised, such as Paget's disease
- You have had a significant infection in the 6 weeks before starting treatment, or have ever had a hepatitis C infection
- You have taken immune-suppressing, immune-modifying, or experimental medications within 30 days before starting treatment
- You have taken a specific medication called obeticholic acid (OCA) within 30 days before the start of the trial
- There may be additional eligibility requirements not listed here (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.
Contact this trial
Principal Investigator: Arena CT.gov Administrator, Arena Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change in Serum Alkaline Phosphatase (ALP) Concentration; Number of Participants With Adverse Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.