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

NCT ID: NCT06050928

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-10-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Inducible Urticaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EP262 150 mg

Once daily

Group Type EXPERIMENTAL

Oral EP262

Intervention Type DRUG

Once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral EP262

Once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Escient Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Advanced Clinical Research Institute

Tampa, Florida, United States

Site Status

Treasure Valley Medical Research

Boise, Idaho, 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

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Site Status

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Site Status

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, United States

Site Status

Innovaderm Research Inc.

Montreal, , Canada

Site Status

Gordon Sussman Clinical Research Inc.

North York, , Canada

Site Status

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 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 (CHDR)

Leiden, South Holland, Netherlands

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Arnau de Vilanova

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Germany Netherlands Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EP-262-102

Identifier Type: -

Identifier Source: org_study_id