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 EVO756DRUG

Oral EVO756, once 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 through an evaluation of treatment emergent adverse events, physical exams, vital signs, laboratory tests, and 12-lead ECGs.

Time frame: Day 1 to Week 6

Secondary Outcomes

Change in Total Fric Score (TFS)

Changes in the number of prongs that elicit a wheal response using a FricTest for subjects with symptomatic dermographism.

Time frame: Day 1 to Week 4

Change in Critical Temperature Threshold (CTT)

Changes in the highest temperature that elicits a wheal response using a TempTest for subjects with cold urticaria.

Time frame: Day 1 to Week 4

Change in pruritus severity at the provocation test site

Changes in the severity of pruritus at the provocation test site using an 11-point numerical rating scale.

Time frame: Day 1 to Week 4

Data from ClinicalTrials.gov

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