Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Drug: Oral EP262Drug: Placebo
- Registration Number
- NCT06077773
- Lead Sponsor
- Escient Pharmaceuticals, Inc
- Brief Summary
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 113
- Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care
- Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines
- Urticaria with a clear underlying etiology other than CSU
- Urticaria with a clearly defined or sole trigger (chronic inducible urticaria)
- Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EP262 50 mg Oral EP262 - EP262 150 mg Oral EP262 - Placebo Placebo - EP262 25 mg Oral EP262 -
- Primary Outcome Measures
Name Time Method Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7) Measured from Baseline to Week 6 Assessed using the UAS7 measuring the intensity of itch and number of hives over the past 7 days
- Secondary Outcome Measures
Name Time Method Change in Itch Severity Score (ISS) over a 7-day period (ISS7) Measured from Baseline to Week 6 Assessed using the ISS7 measuring the intensity of itch over the past 7 days
Change in Hive Severity Score (HSS) over a 7-day period (HSS7) Measured from Baseline to Week 6 Assessed using the HSS7 measuring the number of hives over the past 7 days
Safety and tolerability of EP262 Measured from Day 1 to End of Study or Early Termination (up to 10 weeks) Assessed by the incidence of treatment-emergent adverse events
Trial Locations
- Locations (48)
AllerVie Clinical Research
🇺🇸Birmingham, Alabama, United States
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Little Rock Allergy & Asthma Clinical Research Center
🇺🇸Little Rock, Arkansas, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
First OC Dermatology Research, Inc.
🇺🇸Fountain Valley, California, United States
Allergy and Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
Antelope Valley Clinical Trials
🇺🇸Los Angeles, California, United States
Allervie Clinical Research
🇺🇸Destin, Florida, United States
University of Miami Itch Center
🇺🇸Miami, Florida, United States
Florida Center for Allergy and Asthma Research
🇺🇸Miami, Florida, United States
NuLine Clinical Trial Center
🇺🇸Pompano Beach, Florida, United States
Advanced Clinical Research Institute
🇺🇸Tampa, Florida, United States
Southern Indiana Clinical Trials
🇺🇸New Albany, Indiana, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Velocity Clinical Research, Overland Park, KC Asthma & Allergy
🇺🇸Overland Park, Kansas, United States
Allergy & Asthma Specialists, P.S.C.
🇺🇸Owensboro, Kentucky, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Chesapeake Clinical Research, Inc.
🇺🇸White Marsh, Maryland, United States
The Clinical Research Center LLC
🇺🇸Saint Louis, Missouri, United States
Montana Medical Research, Inc.
🇺🇸Missoula, Montana, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
Bobby Buka MD, PC
🇺🇸New York, New York, United States
Corning Center for Clinical Research
🇺🇸Horseheads, New York, United States
Vital Prospects Clinical Research Institute, PC
🇺🇸Tulsa, Oklahoma, United States
Clinical Partners, LLC
🇺🇸Johnston, Rhode Island, United States
National Allergy and Asthma Research, LLC.
🇺🇸North Charleston, South Carolina, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
Allergy Associates of Utah
🇺🇸Murray, Utah, United States
Red Maple Trials Inc.
🇨🇦Ottawa, Ontario, Canada
Evidence Based Medical Educator Inc
🇨🇦Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
🇨🇦Québec, Quebec, Canada
Allergy Partners Clinical Research
🇺🇸Asheville, North Carolina, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, United States
Toledo Institute of Clinical Research Inc.
🇺🇸Toledo, Ohio, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Universitatsmedizin Mainz der Johannes Gutenberg-Universitat
🇩🇪Mainz, Rheinland-Pfalz, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
🇩🇪Dresden, Sachsen, Germany
Institut fur Allergieforschung Charite - Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Prywatna Praktyka Lekarska Ewa Ring
🇵🇱Warszawa, Mazowieckie, Poland
Centre for Human Drug Research
🇳🇱Leiden, South Holland, Netherlands
Centrum Badan Klinicznych PI-House Sp. z o.o.
🇵🇱Gdańsk, Pomorskie, Poland
Hospital del Mar
🇪🇸Barcelona, Spain
Pim Mswia
🇵🇱Warsaw, Masovian Voivodeship, Poland
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain