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

Evommune, Inc.30 enrolled

Overview

This phase 2a trial will evaluate the safety and efficacy of EVO756 in subjects with chronic inducible urticaria, including symptomatic dermographism and cold urticaria.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Inducible Urticaria

Interventions

Oral EVO756 300 mg QDDRUG

Oral EVO756, 300 mg once daily

Oral EVO756 50 mg BIDDRUG

Oral EVO756 50 mg twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (18)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, United States

California Allergy and Asthma Medical Group

Los Angeles, California, United States

Outcomes

Primary Outcomes

Safety and Tolerability

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

Time frame: Day 1 to Week 6

Secondary Outcomes

Change in Total Fric Score (TFS)

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.

Time frame: Day 1 to Week 4

Change in Pruritus Severity at the Provocation Test Site

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.

Time frame: Day 1 to Week 4

Data from ClinicalTrials.gov

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