EP547 100 mg for Pruritus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pruritus+3 More
EP547 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)

Eligible Conditions
  • Pruritus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Measured from Day 1 to Week 6

Measured at Week 6
Pruritus
Week 6
Change in 5-D Itch
Change in 5-D Itch Scale
Change in Worst Itch Numeric Rating Scale (WI-NRS)
Change in Worst Itch Numeric Rating Scare (WI-NRS)
Proportion of subjects with WI-NRS <4
Proportion of subjects with a reduction in WI-NRS ≥2 from baseline
Proportion of subjects with a reduction in WI-NRS ≥3 from baseline
Proportion of subjects with a reduction in WI-NRS ≥4 from baseline
Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S
Week 6
The incidence of adverse events
Week 6
Maximum Plasma Concentration [Cmax]

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

EP547 100 mg
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

58 Total Participants · 2 Treatment Groups

Primary Treatment: EP547 100 mg · Has Placebo Group · Phase 2

EP547 100 mg
Drug
Experimental Group · 1 Intervention: EP547 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EP547
2020
Completed Phase 1
~90

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured from day 1 to week 6

Who is running the clinical trial?

Escient Pharmaceuticals, IncLead Sponsor
1 Previous Clinical Trials
89 Total Patients Enrolled
1 Trials studying Pruritus
89 Patients Enrolled for Pruritus

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are taking anti-pruritic and anti-cholestatic medication
You must have a concomitant inflammatory bowel disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: November 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.