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

NCT06050928 | Completed Phase 1 FDA Drug

• 1 other identifier: EP-262-102
• Study Type: interventional
• Target: 33
• Locations: 5 countries
• Sites: 15

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.

Conditions

Chronic Inducible Urticaria

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of EP262

  Assessed by the incidence of treatment-emergent adverse events

  Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)

Secondary Outcomes (2)

• Change in Critical Friction Threshold (CFT)

  Measured from Baseline to Week 4

• Change in Critical Temperature Threshold (CTT)

  Measured from Baseline to Week 4

Study Arms (1)

EP262 150 mg

EXPERIMENTAL

Once daily

Drug: Oral EP262

Interventions

Oral EP262 DRUG

Once daily

EP262 150 mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Escient Pharmaceuticals, Inc: lead

Study Sites (15)

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Allergy & Asthma Specialists, P.S.C.

Owensboro, Kentucky, 42301, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

National Allergy and Asthma Research, LLC.

North Charleston, South Carolina, 29420, United States

Location

Innovaderm Research Inc.

Montreal, H2X 2V1, Canada

Location

Gordon Sussman Clinical Research Inc.

North York, M3B 3S6, Canada

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Institut fur Allergieforschung Charite - Universitatsmedizin Berlin

Berlin, 12203, Germany

Location

Centre for Human Drug Research (CHDR)

Leiden, South Holland, 2333 CL, Netherlands

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Arnau de Vilanova

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Chronic Inducible Urticaria

Condition Hierarchy (Ancestors)

Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 22, 2023
• Study Start: August 30, 2023
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CA (2); US (7); DE (3); NL (1); ES (2)