Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05525520
Other study ID # EP-547-201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 6, 2022
Est. completion date September 2024

Study information

Verified date May 2024
Source Escient Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 58
Est. completion date September 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Drug:
EP547
Once daily
Placebo
Once daily

Locations

Country Name City State
Belgium UZ Antwerpen Antwerpen
Belgium UZ Gent Gent
Belgium UZ Leuven Leuven
Canada University of Alberta Edmonton Alberta
Canada Centre hospitalier de l'Université de Montréal (CHUM) Montreal Quebeck
Canada Toronto Centre for Liver Disease Toronto General Hospital Toronto Ontario
Canada (G.I.R.I.) GI Research Institute Vancouver British Columbia
France APHP Avicenne Bobigny
France CHU Grenoble- Alpes- Site Nord Grenoble
France CHU de Lille Lille
France Saint Antoine Hospital Paris
France Hospital Rangueil Toulouse
France Paul Brousse Hospital Villejuif
Israel Carmel Medical Center Haifa
Israel Rambam Medical Center- Keriat Eliezer Family Health Center Haifa
Israel Hadassah Medical Center (Ein-Karem) Jerusalem
Israel Chaim Sheba Medical Center Ramat Gan
Netherlands Academic Medical Center- University of Amsterdam Amsterdam
Spain Hospital General Universitario Alicante Alicante
Spain Hospital Clinic Barcelona Barcelona
Spain Hospital de Montecelo Pontevedra
Spain Campus Hospital Universitario Virgen del Rocio Sevilla
Spain La Fe University and Polytechnic Hospital Valencia
Spain Hospital Universitario Miguel Servet Zaragoza
United Kingdom University Hospitals Birmingham NHS Foundation Trust Birmingham
United Kingdom Glasgow Royal Infirmary Glasgow
United Kingdom King's College Hospital NHS Foundation Trust London
United Kingdom Institute of Cellular Medicine, Newcastle University Newcastle
United Kingdom Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich
United Kingdom University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit Nottingham
United Kingdom University Hospitals Plymouth NHS Trust - Derriford Hospital Plymouth
United States University of Alabama Birmingham Hospital Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Gastro Health Research Cincinnati Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Southern California Research Center Coronado California
United States Science 37 Culver City California
United States The Liver Institute at Methodist Dallas Medical Center Dallas Texas
United States Liver Associates of Texas, PA Houston Texas
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States Gastro Health & Nutrition Katy Texas
United States University of Miami - Schiff Center for Liver Diseases Miami Florida
United States University of Minnesota Minneapolis Minnesota
United States Ochsner Medical Center New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States NYU Grossman School of Medicine Gastroenterology and Hepatology New York New York
United States Digestive & Liver Disease Specialists Norfolk Virginia
United States California Liver Research Institute Pasadena California
United States Dignity Health Center for Clinical Research at St. Joseph Hospital Phoenix Arizona
United States UPMC Center for Liver Disease Pittsburgh Pennsylvania
United States Bon Secours Liver Institute of Virginia Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
Escient Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Israel,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable) Measured from Baseline to Week 6
Secondary Change in 5-D Itch Scale The 5-D Itch Scale will be used to measure change in pruritus covering five dimensions: degree, duration, direction, disability, and distribution. The total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse quality of life Measured from Baseline to Week 6
Secondary Proportion of subjects with improvement in pruritus as defined by PGI-C Change in pruritus will be measured using the PGI-C scale to indicate overall change in pruritus in the past 7 days compared to before treatment using a 7-point scale from much improved to much worse Measured at Week 6
Secondary Proportion of subjects with improvement in pruritus severity from baseline as defined by PGI-S Pruritus will be measured using the PGI-S scale to indicate severity of itch in the past 7 days using a 4-point scale from none to severe Measured from Baseline to Week 6
Secondary Proportion of subjects with a reduction in WI-NRS =2 from baseline Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable) Measured from Baseline to Week 6
Secondary Proportion of subjects with a reduction in WI-NRS =3 from baseline Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable) Measured from Baseline to Week 6
Secondary Proportion of subjects with a reduction in WI-NRS =4 from baseline Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable) Measured from Baseline to Week 6
Secondary Proportion of subjects with WI-NRS <4 Pruritus will be measured using a WI-NRS scale to indicate the intensity of itch in the past 24 hours from 0 (No Itching) to 10 (Worst Itching Imaginable) Measured from Baseline to Week 6
Secondary The incidence of adverse events Safety and tolerability of EP547 measured through reporting of adverse events Measured from Day 1 to End of Study or Early Termination (up to Week 6)
Secondary Maximum Plasma Concentration [Cmax] To evaluate the pharmacokinetics of EP547 Measured from Day 1 to Week 6
See also
  Status Clinical Trial Phase
Completed NCT05038982 - Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin Phase 2
Completed NCT04510090 - Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus Phase 1
Terminated NCT01825655 - Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching Phase 4
Completed NCT02143973 - Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
Completed NCT01236859 - Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus N/A
Completed NCT00782054 - Evaluation of Post Burn Rehabilitation Population for Itch Control Phase 4
Completed NCT04999787 - A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus Phase 2
Recruiting NCT04256759 - Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Phase 2
Completed NCT04337073 - The Effect of Propofol on Dexamethasone-induced Perineal Pruritus Early Phase 1
Completed NCT04415034 - Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT04399525 - Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. N/A
Recruiting NCT02432508 - Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis N/A
Completed NCT02653703 - L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain N/A
Completed NCT01963793 - Topical Aprepitant in Prurigo Patients Phase 2
Completed NCT01232985 - Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults Phase 2
Not yet recruiting NCT00577967 - Gabapentin - A Solution to Uremic Pruritus? N/A
Recruiting NCT06120907 - Swiss Itch Registry
Recruiting NCT04589429 - Adding Nalbuphine for Control of Intrathecal Morphine Pruritus Phase 2
Completed NCT03322137 - Safety, Efficacy, and Tolerability of SNA-120 in Subjects With Pruritus Associated With Psoriasis Vulgaris Phase 2