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OpenTrials
Completed

NCT Number: NCT06050928

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

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

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Innovaderm Research Inc., Montreal, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral EP262

Drug

Once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Escient Pharmaceuticals, Inc

Industry

Registry information

Official study title

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

Acronym: CALM-CIndU

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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