Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
NCT ID: NCT06077773
Last Updated: 2025-12-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
113 participants
INTERVENTIONAL
2023-09-25
2025-01-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EP262 50 mg
Oral EP262
Once daily
EP262 150 mg
Oral EP262
Once daily
Placebo
Placebo
Once daily
EP262 25 mg
Oral EP262
Once daily
Interventions
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Oral EP262
Once daily
Placebo
Once daily
Eligibility Criteria
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Inclusion Criteria
* Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Escient Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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AllerVie Clinical Research
Birmingham, Alabama, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Little Rock Allergy & Asthma Clinical Research Center
Little Rock, Arkansas, 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
University of South Florida
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 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
Johns Hopkins University
Baltimore, Maryland, United States
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, United States
The Clinical Research Center LLC
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Corning Center for Clinical Research
Horseheads, New York, United States
Bobby Buka MD, PC
New York, New York, United States
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
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 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
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitatsmedizin Mainz der Johannes Gutenberg-Universitat
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, Germany
Institut fur Allergieforschung Charite - Universitatsmedizin Berlin
Berlin, , Germany
Centre for Human Drug Research
Leiden, South Holland, Netherlands
Prywatna Praktyka Lekarska Ewa Ring
Warsaw, Masovian Voivodeship, Poland
Pim Mswia
Warsaw, Masovian Voivodeship, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
Hospital del Mar
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EP-262-201
Identifier Type: -
Identifier Source: org_study_id