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

Phase 1

Completed

• Conditions: Chronic Inducible Urticaria
• Interventions: Drug: Oral EP262

• Registration Number: NCT06050928
• Lead Sponsor: Escient Pharmaceuticals, Inc

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-08-30
• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-22
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EP262 150 mg	Oral EP262	Once daily

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of EP262	Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)	Assessed by the incidence of treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Change in Critical Temperature Threshold (CTT)	Measured from Baseline to Week 4	Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria)
Change in Critical Friction Threshold (CFT)	Measured from Baseline to Week 4	Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism)

Trial Locations

Locations (15)

Allergy & Asthma Specialists, P.S.C.; 🇺🇸 Owensboro, Kentucky, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

National Allergy and Asthma Research, LLC.; 🇺🇸 North Charleston, South Carolina, United States

Bernstein Clinical Research Center, LLC; 🇺🇸 Cincinnati, Ohio, United States

Advanced Clinical Research Institute; 🇺🇸 Tampa, Florida, United States

Treasure Valley Medical Research; 🇺🇸 Boise, Idaho, United States

Allergy and Clinical Immunology Associates; 🇺🇸 Pittsburgh, Pennsylvania, United States

Innovaderm Research Inc.; 🇨🇦 Montréal, Canada

Gordon Sussman Clinical Research Inc.; 🇨🇦 North York, Canada

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden; 🇩🇪 Dresden, Sachsen, Germany

Institut fur Allergieforschung Charite - Universitatsmedizin Berlin; 🇩🇪 Berlin, Germany

Centre for Human Drug Research (CHDR); 🇳🇱 Leiden, South Holland, Netherlands

Hospital Arnau de Vilanova; 🇪🇸 Valencia, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain