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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Inducible Urticaria
• Intervention / Treatment: Drug: Oral EP262

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montréal, Canada, H2X 2V1
    • Innovaderm Research Inc.
  • North York, Canada, M3B 3S6
    • Gordon Sussman Clinical Research Inc.
• Germany
  • Berlin, Germany, 12203
    • Institut fur Allergieforschung Charite - Universitatsmedizin Berlin
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
• Netherlands
  • South Holland
    • Leiden, South Holland, Netherlands, 2333 CL
      • Centre for Human Drug Research (CHDR)
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova
• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Kentucky
    • Owensboro, Kentucky, United States, 42301
      • Allergy & Asthma Specialists, P.S.C.
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center, LLC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EP262 150 mg; Once daily	Drug: Oral EP262; Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Escient Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chronic Urticaria; Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Vascular; Chronic Inducible Urticaria; Urticaria
• Other Study ID Numbers: EP-262-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No