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Completed

NCT Number: NCT06603220

A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria

This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, 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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cahaba Dermatology & Skin Health Center, LLC, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of chronic inducible urticaria for at least 3 months.
  • Positive response following provocation using the TempTest or FricTest at Screening and Day 1.

Exclusion criteria

  • History of diseases other than chronic inducible urticaria or chronic spontaneous urticaria with urticaria or angioedema symptoms, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema.
  • Concurrent use of certain medications, including antihistamines.
  • Any clinically significant disease, or other skin disease or skin markings (e.g., extensive scarring, tattoos), that might confound the evaluation of safety or efficacy.

Treatment and study plan

Oral EVO756 300 mg QD

Drug

Oral EVO756, 300 mg once daily

Oral EVO756 50 mg BID

Drug

Oral EVO756 50 mg twice daily

Primary outcomes

  1. Safety and Tolerability

    Time frame: Day 1 to Week 6

    Safety will be assessed by the total number of subjects with at least one TEAE

Secondary outcomes

  1. Change in Total Fric Score (TFS)

    Time frame: Day 1 to Week 4

    The Total Fric Score represents the total number of linear wheals with a width of ≥3 mm induced following the Fric Test, from 0 to 4; 0 representing the minimum score (better outcome), and 4 representing the maximum score (worse outcome). A complete response is equal to a response of 0, where a subject began with at least a score of 1. A partial response is equal to a decrease of at least 2 points in the score (wheals), where a subject began with at least a score of 2. Partial responders may also be considered complete responders if their final score is equal to 0.

  2. Change in Pruritus Severity at the Provocation Test Site

    Time frame: Day 1 to Week 4

    The Pruritus Severity is determined based on the Pruritus Numeric Rating Scale, or P-NRS. This is an 11-point scale completed by the subject prior to and approximately 10 minutes after completion of the provocation test, where 10 represents the worst itch (maximum), and 0 represents no itch (minimum) at the site of the urticaria provocation test.

Sponsors and collaborators

Lead sponsor

Evommune, Inc.

Industry

Registry information

Official study title

An Open Label Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
May 19, 2026

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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