← Back to Search

Unknown

EP547 for Cholestatic Pruritus (PACIFIC Trial)

Q: Has the Food and Drug Administration certified EP547 100 mg as safe for use?

Based on our internal analysis, EP547 100 mg was rated a 2 for safety due to the absence of evidence regarding its efficacy but some information about its security.

Q: What is the end-goal of this exploratory endeavor?

The primary aim of this clinical trial, measured between Baseline and Week 6, is to assess the change in Worst Itch Numeric Rating Scale (WI-NRS). Secondary objectives include measuring the reduction in WI-NRS ≥3 from baseline using a scale ranging from 0 (No Itching) to 10 (Worst Itching Imaginable), monitoring the safety and tolerability of EP547 through reporting adverse events, as well as ascertaining improvement in pruritus via Patient Global Impression Change score.

Q: Is it possible for me to take part in this experimental research?

This study is seeking 58 participants aged between 18 and 80, who are currently suffering from pruritus. To be eligible for the trial, candidates must also fulfil a number of requirements: use of anti-pruritic and anti-cholestatic drugs (including UDCA and obeticholic acid) if additional criteria are met; individuals with concomitant inflammatory bowel disease must meet other relevant criteria; documented primary biliary cholangitis or PSC diagnosis; presence of consistent moderate to severe itching sensations.

Q: Are there opportunities for enrollment in this experiment at present?

According to the clinicaltrials.gov website, this research project is currently recruiting subjects who meet its criteria; it was initially posted on October 6th 2022 and has recently been updated on November 15th 2022.

Q: Is the cutoff age for this trial under forty years old?

Patients hoping to be accepted into this clinical trial must range in age from 18 - 80. There are also 7 trials that can accept adolescents and 70 for elderly applicants.

Q: At how many distinct locations is this clinical experiment being conducted?

The research team is conducting this trial from multiple sites, including Montefiore Medical Center in Bronx, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>; Gastro Health &#x26; Nutrition in Katy, <a href="https://www.withpower.com/clinical-trials/mississippi">Mississippi</a>; and Southern Therapy and Advanced Research in Jackson, <a href="https://www.withpower.com/clinical-trials/california">California</a>.

Q: How many subjects are currently receiving treatment within this investigation?

Affirmative. According to the information published on clinicaltrials.gov, this research is currently recruiting volunteers - with 58 participants needed from 7 different medical centres. The study was initially posted on October 6th 2022 and most recently revised on November 15th 2022.

Phase 2

Recruiting

Research Sponsored by Escient Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)

Age 18 to 80 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from day 1 to week 6

Awards & highlights

PACIFIC Trial Summary

This trial will test a new treatment for people with itchy skin caused by liver disease.

Who is the study for?

Adults aged 18-80 with moderate to severe itching due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC) can join. They must not have cirrhosis, significant bowel issues, high-grade bile duct strictures, biliary stents, other liver diseases, or plans for a liver transplant.Check my eligibility

What is being tested?

The trial is testing EP547 against a placebo in patients with cholestatic pruritus from PBC or PSC. It aims to see if EP547 can relieve itching better than a non-active treatment.See study design

What are the potential side effects?

Possible side effects of EP547 are not detailed here but may include reactions similar to other medications for liver conditions and itching such as digestive discomfort, skin reactions, and changes in blood tests related to the liver.

PACIFIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PBC or PSC.

Select...

I am between 18 and 80 years old.

Select...

I often have moderate to severe itching.

PACIFIC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from day 1 to week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured from day 1 to week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from day 1 to week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Worst Itch Numeric Rating Scale (WI-NRS)

Secondary outcome measures

Change in 5-D Itch Scale

Maximum Plasma Concentration [Cmax]

Proportion of subjects with WI-NRS <4

+6 more

Side effects data

From 2021 Phase 1 trial • 89 Patients • NCT04510090

17%

Erythema

17%

Skin abrasion

100%

80%

60%

40%

20%

Study treatment Arm

SD-UP EP547 75 mg

SAD-HS EP547 225 mg

MAD-HS EP547 225 mg

SAD-HS EP547 675 mg

FE-HS EP547 75 mg

SAD-HS EP547 450 mg

SAD-HS EP547 25 mg

MAD-HS EP547 25 mg

MD-CP EP547 30 mg

SAD-HS EP547 75 mg

MAD-HS EP547 75 mg

SD-CP EP547 75 mg

SAD-HS Placebo

MAD-HS Placebo

MD-CP Placebo

MD-UP Placebo

MD-UP EP547 20 mg

PACIFIC Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EP547 100 mgExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EP547

2020

Completed Phase 1

~90

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Escient Pharmaceuticals, IncLead Sponsor

4 Previous Clinical Trials

239 Total Patients Enrolled

Media Library

EP547 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05525520 — Phase 2

Itching Research Study Groups: EP547 100 mg, Placebo

Itching Clinical Trial 2023: EP547 Highlights & Side Effects. Trial Name: NCT05525520 — Phase 2

EP547 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525520 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration certified EP547 100 mg as safe for use?

"Based on our internal analysis, EP547 100 mg was rated a 2 for safety due to the absence of evidence regarding its efficacy but some information about its security."

Answered by AI

What is the end-goal of this exploratory endeavor?

"The primary aim of this clinical trial, measured between Baseline and Week 6, is to assess the change in Worst Itch Numeric Rating Scale (WI-NRS). Secondary objectives include measuring the reduction in WI-NRS ≥3 from baseline using a scale ranging from 0 (No Itching) to 10 (Worst Itching Imaginable), monitoring the safety and tolerability of EP547 through reporting adverse events, as well as ascertaining improvement in pruritus via Patient Global Impression Change score."

Answered by AI

Is it possible for me to take part in this experimental research?

"This study is seeking 58 participants aged between 18 and 80, who are currently suffering from pruritus. To be eligible for the trial, candidates must also fulfil a number of requirements: use of anti-pruritic and anti-cholestatic drugs (including UDCA and obeticholic acid) if additional criteria are met; individuals with concomitant inflammatory bowel disease must meet other relevant criteria; documented primary biliary cholangitis or PSC diagnosis; presence of consistent moderate to severe itching sensations."

Answered by AI

Are there opportunities for enrollment in this experiment at present?

"According to the clinicaltrials.gov website, this research project is currently recruiting subjects who meet its criteria; it was initially posted on October 6th 2022 and has recently been updated on November 15th 2022."

Answered by AI

Is the cutoff age for this trial under forty years old?

"Patients hoping to be accepted into this clinical trial must range in age from 18 - 80. There are also 7 trials that can accept adolescents and 70 for elderly applicants."

Answered by AI

At how many distinct locations is this clinical experiment being conducted?

"The research team is conducting this trial from multiple sites, including Montefiore Medical Center in Bronx, New york; Gastro Health & Nutrition in Katy, Mississippi; and Southern Therapy and Advanced Research in Jackson, California."

Answered by AI

How many subjects are currently receiving treatment within this investigation?

"Affirmative. According to the information published on clinicaltrials.gov, this research is currently recruiting volunteers - with 58 participants needed from 7 different medical centres. The study was initially posted on October 6th 2022 and most recently revised on November 15th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

2022. "Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525520.

All > Liver Cirrhosis