Phase 2 Primary Biliary Cholangitis Trial, Completed NCT05525520 Sponsor: Escient Pharmaceuticals, Inc Condition: Primary Biliary Cholangitis
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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 enrolled 62 people in total. For the first six weeks, 30 participants received a placebo (an inactive dummy tablet) followed by the study drug EP547, while 32 received EP547 throughout. The trial was mainly measuring changes in itch severity using a scoring tool called the Worst Itch Numeric Rating Scale (WI-NRS), where 0 means no itching and 10 means the worst itching imaginable. Several other itch-related questionnaires were also tracked as secondary measurements. The reported data shows that, over the first six weeks, the placebo group's average itch score dropped by 2.20 points from their starting score, while the group who received EP547 from the beginning saw a drop of 1.75 points. For a broader itch questionnaire (the 5-D Itch Scale, scored from 5 to 25, with higher scores meaning worse itch), both groups reported a similar reduction of around 3.7–3.8 points. When participants were asked to rate their overall impression of change in itch, about 55.6% of the placebo group and 60.7% of the EP547 group said their itch had at least minimally improved. When asked about itch severity category, 56.0% of the placebo group and 52.0% of the EP547 group reported moving to a less severe category. Around 44.4% of placebo participants and 35.7% of EP547 participants recorded a drop of at least 2 points on the itch scale, while 37.0% and 25.0% respectively recorded a drop of at least 3 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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, Completed

NCT05525520
Completed Phase 2

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
  • You have been diagnosed with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC), which are chronic liver conditions
  • You experience moderate to severe itching (pruritus) on a consistent basis related to your liver condition
  • You may still be eligible if you are currently taking medications to help with itching or liver disease, including UDCA or obeticholic acid, provided you meet some additional requirements (confirm with trial site)
  • If you also have inflammatory bowel disease, you may still be considered but will need to meet some extra criteria (confirm with trial site)

Who may not be able to join:

  • Your itching is caused by something other than PBC or PSC
  • You have previously had a liver transplant or have one planned
  • You have been diagnosed with cirrhosis, whether mild or advanced
  • You have another condition that is causing liver disease
  • You have a diagnosis of secondary sclerosing cholangitis, which is a different type of bile duct condition
  • You have significant blockages in your bile ducts or have a biliary stent (a small tube placed in a bile duct)
  • You have had a large portion of your small intestine removed, or have a condition called short bowel syndrome
  • Your blood test results at the initial screening appointment fall outside the acceptable range for this trial (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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
Escient Pharmaceuticals, Inc
Registry
ClinicalTrials.gov
Start date
6 October 2022
Est. completion
17 July 2024

Where this trial is recruiting

🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇮🇱 Israel 🇳🇱 Netherlands 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6

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: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov