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

An Open Label 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.

Study Overview

• Status: Completed
• Conditions: Chronic Inducible Urticaria
• Intervention / Treatment: Drug: Oral EVO756 300 mg QD; Drug: Oral EVO756 50 mg BID

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology & Skin Health Center, LLC
  • California
    • Los Angeles, California, United States, 90025
      • California Allergy and Asthma Medical Group
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research
    • San Diego, California, United States, 92121
      • West Dermatology Research Center
  • Florida
    • Tampa, Florida, United States, 33607
      • Advanced Clinical Research Institute
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Laboratories of Savannah, Inc.
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • Southern Indiana Clinical trials
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trials Center, P.C.
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research
  • Maryland
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research, Inc
  • New York
    • New York, New York, United States, 10128
      • OptiSkin Medical
  • North Dakota
    • Fargo, North Dakota, United States, 58013
      • Red River Research Partners
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley Dermatology Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma, and Clinical Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EVO756 300 mg QD; Oral EVO756 300 mg QD	Drug: Oral EVO756 300 mg QD; Oral EVO756, 300 mg once daily
Experimental: EVO756 50 mg BID; Oral EVO756 50 mg BID	Drug: Oral EVO756 50 mg BID; Oral EVO756 50 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability	Safety will be assessed by the total number of subjects with at least one TEAE	Day 1 to Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 1 to Week 4

Collaborators and Investigators

• Sponsor: Evommune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chronic inducible urticaria; inducible urticaria
• Additional Relevant MeSH Terms: Chronic Urticaria; Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Inducible Urticaria; BID protein, human
• Other Study ID Numbers: EVO756-CIU001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No