Phase 2
N=62
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT05525520 ↗Enrolled (actual)
62
Serious AEs
1.1%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6 — -2.20; -1.75 scores on a scale — p=0.4577
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EP547 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Escient Pharmaceuticals, Inc
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Worst Itch Numeric Rating Scale (WI-NRS) Score up to Week 6 |
-2.20; -1.75 | 0.4577 |
| SECONDARY Change From Baseline in the 5-D Itch Scale Total Score at Week 6 |
-3.7; -3.8 | — |
| SECONDARY Percentage of Participants With Improvement in Pruritus as Defined by Patient Global Impression of Change (PGI-C) at Week 6 |
55.6; 60.7 | — |
| SECONDARY Percentage of Participants With Improvement in Pruritus Severity From Baseline as Defined by Change in Patient Global Impress of Severity (PGI-S) at Week 6 |
56.0; 52.0 | — |
| SECONDARY Percentage of Participants With a Reduction in WI-NRS Score ≥2 From Baseline at Week 6 |
44.4; 35.7 | — |
| SECONDARY Percentage of Participants With a Reduction in WI-NRS Score ≥3 From Baseline at Week 6 |
37.0; 25.0 | — |
| SECONDARY Percentage of Participants With a Reduction in WI-NRS Score ≥4 From Baseline at Week 6 |
37.0; 17.9 | — |
| SECONDARY Percentage of Participants With a WI-NRS Score <4 at Week 6 |
42.9; 35.7 | — |
| SECONDARY Double-blind Treatment Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug |
15; 18; 0; 0; 5; 5 | — |
| SECONDARY Open-label Extension Period: Number of Participants With Any TEAE, Any ≥Grade 3 TEAE, Any Related TEAE, and Any TEAE That Led to Discontinuation of Study Drug |
16; 15; 2; 0; 5; 2 | — |
| SECONDARY Double-blind Treatment Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Open-label Extension Period: Number of Participants With Any Serious TEAE, Any ≥Grade 3 Serious TEAE, Any Related Serious TEAE, and Any Serious TEAE That Led to Discontinuation of Study Drug |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Double-blind Treatment Period: Number of Participants With Any Treatment-emergent (TE) Adverse Event of Special Interest (AESI), Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Open-label Extension Period: Number of Participants With Any Treatment-emergent (TE) AESI, Any ≥Grade 3 TE AESI, Any Related TE AESI, and Any TE AESI That Led to Discontinuation of Study Drug |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Any Clinically Meaningful Changes From Baseline in Clinically Meaningful in Clinical Laboratory Test Results |
3; 0 | — |
| SECONDARY Number of Participants With Any Clinically Meaningful Changes From Baseline in Vital Sign Measurements |
0; 1 | — |
| SECONDARY Number of Participants With Any Clinically Significant Changes From Baseline in Electrocardiogram (ECG) Parameters |
0; 0 | — |
| SECONDARY Plasma Concentration of EP547 and Metabolites |
2661.0; 5197.7; 5698.4; 6267.9; 5786.5; 6617.4 | — |
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)
Eligibility Criteria
Inclusion Criteria
- Age 18 to 80 years
- Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC)
- Presence of consistent moderate to severe pruritus
- Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additional criteria
- Individuals with concomitant inflammatory bowel disease must meet additional relevant criteria
Exclusion Criteria
- Pruritus associated with an etiology other than PBC or PSC
- Prior or planned liver transplantation
- Evidence of compensated or decompensated cirrhosis
- Alternative causes of liver disease
- Presence of documented secondary sclerosing cholangitis
- Current evidence of clinically significant high-grade strictures or presence of biliary stent
- History of significant small bowel resection or short bowel syndrome
- Has exclusionary laboratory or biochemical results at Screening
Data sourced from ClinicalTrials.gov (NCT05525520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.