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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

Phase 2
Waitlist Available
Research Sponsored by Enanta Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and week 12: pre-dose and 2, 6 and 8 hours post-dose

Summary

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis

Eligible Conditions
  • Primary Biliary Cholangitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and week 12: pre-dose and 2, 6 and 8 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and week 12: pre-dose and 2, 6 and 8 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With At Least a 20% Reduction in Alkaline Phosphatase (ALP) or Normalization of ALP at Week 12 Compared to Baseline
Secondary study objectives
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of EDP-305 and Its Metabolites
Change From Baseline to Week 12 in Domain Scores on the Primary Biliary Cholangitis-40 (PBC-40) Quality of Life (QoL) Assessment
Change From Baseline to Week 12 in Domain and Total Scores on the 5D-Itch Scale
+13 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-305 2.5 mgExperimental Treatment1 Intervention
Subjects will take 2 tablets once a day orally for 12 weeks
Group II: EDP-305 1 mgExperimental Treatment1 Intervention
Subjects will take 2 tablets once a day orally for 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Subjects will take two tablets once a day orally for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-305 1 mg
2017
Completed Phase 2
~70
EDP-305 2.5 mg
2017
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Enanta PharmaceuticalsLead Sponsor
33 Previous Clinical Trials
2,286 Total Patients Enrolled
Pharmaceutical Research AssociatesOTHER
17 Previous Clinical Trials
12,996 Total Patients Enrolled
Enanta Pharmaceuticals, IncLead Sponsor
40 Previous Clinical Trials
3,053 Total Patients Enrolled
Triangle BiostatisticsUNKNOWN
1 Previous Clinical Trials
134 Total Patients Enrolled
~9 spots leftby Dec 2025
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