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

August 29, 2024 updated by: Escient Pharmaceuticals, Inc

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
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)
Time Frame: 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)
Measured from Baseline to Week 4
Change in Critical Temperature Threshold (CTT)
Time Frame: Measured from Baseline to Week 4
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

This is where you will find people and organizations involved with this study.

Sponsor

Escient Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 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 (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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