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Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria

Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)

NCT06050928•Escient Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing
•Willing to discontinue chronic treatment with antihistamines during the study

Exclusion Criteria

•Urticaria with a clear underlying etiology other than symptomatic dermographism or cold urticaria
•Other active skin diseases that might confound the study evaluations (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
•Regularly experience wheals covering the area of the body where skin testing will be conducted (eg, more than one third of the volar surface of the forearms)

Locations (15)

Advanced Clinical Research Institute

Tampa, Florida, United States

Treasure Valley Medical Research

Boise, Idaho, United States

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, United States

Johns Hopkins University

Baltimore, Maryland, United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, United States

Innovaderm Research Inc.

Montreal, Canada

Gordon Sussman Clinical Research Inc.

North York, Canada

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Key Dates

Start Date

August 30, 2023

Primary Completion Date

October 22, 2024

Completion Date

October 22, 2024

Last Updated

December 9, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Inducible Urticaria

Interventions

Oral EP262

DRUG

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

NCT07266402

Chronic Inducible UrticariaCold Urticaria+2 more

View study

RECRUITINGPHASE2

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

NCT06931405

Chronic Inducible UrticariaChronic Spontaneous Urticaria

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria

Inclusion Criteria

Exclusion Criteria

A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)

Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU)

A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria

Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines