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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2025-01-16

Brief Summary

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Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

Detailed Description

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Conditions

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Chronic Spontaneous Urticaria

Keywords

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Chronic Spontaneous Urticaria Chronic Urticaria Urticaria EP262 CALM-CSU CALM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EP262 50 mg

Group Type EXPERIMENTAL

Oral EP262

Intervention Type DRUG

Once daily

EP262 150 mg

Group Type EXPERIMENTAL

Oral EP262

Intervention Type DRUG

Once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily

EP262 25 mg

Group Type EXPERIMENTAL

Oral EP262

Intervention Type DRUG

Once daily

Interventions

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Oral EP262

Once daily

Intervention Type DRUG

Placebo

Once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Escient Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AllerVie Clinical Research

Birmingham, Alabama, United States

Site Status

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Site Status

Little Rock Allergy & Asthma Clinical Research Center

Little Rock, Arkansas, United States

Site Status

First OC Dermatology Research, Inc.

Fountain Valley, California, United States

Site Status

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, United States

Site Status

Antelope Valley Clinical Trials

Los Angeles, California, United States

Site Status

Allervie Clinical Research

Destin, Florida, United States

Site Status

University of Miami Itch Center

Miami, Florida, United States

Site Status

Florida Center for Allergy and Asthma Research

Miami, Florida, United States

Site Status

NuLine Clinical Trial Center

Pompano Beach, Florida, United States

Site Status

Advanced Clinical Research Institute

Tampa, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Treasure Valley Medical Research

Boise, Idaho, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

Southern Indiana Clinical Trials

New Albany, Indiana, United States

Site Status

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status

Velocity Clinical Research, Overland Park, KC Asthma & Allergy

Overland Park, Kansas, United States

Site Status

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Chesapeake Clinical Research, Inc.

White Marsh, Maryland, United States

Site Status

The Clinical Research Center LLC

St Louis, Missouri, United States

Site Status

Montana Medical Research, Inc.

Missoula, Montana, United States

Site Status

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Site Status

Corning Center for Clinical Research

Horseheads, New York, United States

Site Status

Bobby Buka MD, PC

New York, New York, United States

Site Status

Allergy Partners Clinical Research

Asheville, North Carolina, United States

Site Status

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Site Status

Toledo Institute of Clinical Research Inc.

Toledo, Ohio, United States

Site Status

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Site Status

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Site Status

Clinical Partners, LLC

Johnston, Rhode Island, United States

Site Status

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, United States

Site Status

Progressive Clinical Research, PA

San Antonio, Texas, United States

Site Status

Allergy Associates of Utah

Murray, Utah, United States

Site Status

Red Maple Trials Inc.

Ottawa, Ontario, Canada

Site Status

Evidence Based Medical Educator Inc

Toronto, Ontario, Canada

Site Status

Centre de Recherche Saint-Louis

Québec, Quebec, Canada

Site Status

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Site Status

Universitatsmedizin Mainz der Johannes Gutenberg-Universitat

Mainz, Rhineland-Palatinate, Germany

Site Status

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, Germany

Site Status

Institut fur Allergieforschung Charite - Universitatsmedizin Berlin

Berlin, , Germany

Site Status

Centre for Human Drug Research

Leiden, South Holland, Netherlands

Site Status

Prywatna Praktyka Lekarska Ewa Ring

Warsaw, Masovian Voivodeship, Poland

Site Status

Pim Mswia

Warsaw, Masovian Voivodeship, Poland

Site Status

Centrum Badan Klinicznych PI-House Sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Arnau de Vilanova

Valencia, , Spain

Site Status

Countries

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United States Canada Germany Netherlands Poland Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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EP-262-201

Identifier Type: -

Identifier Source: org_study_id