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

NCT06603220 | Completed Phase 2 FDA Drug

• 1 other identifier: EVO756-CIU001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Chronic Inducible Urticaria

Keywords

chronic inducible urticaria; inducible urticaria

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 to Week 6

Secondary Outcomes (3)

• Change in Total Fric Score (TFS)

  Day 1 to Week 4

• Change in Critical Temperature Threshold (CTT)

  Day 1 to Week 4

• Change in pruritus severity at the provocation test site

  Day 1 to Week 4

Study Arms (1)

EVO756

EXPERIMENTAL

Drug: Oral EVO756

Interventions

Oral EVO756 DRUG

Oral EVO756, once daily

EVO756

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evommune, Inc.: lead

Study Sites (18)

Cahaba Dermatology & Skin Health Center, LLC

Birmingham, Alabama, 35244, United States

Location

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

Location

Integrative Skin Science and Research

Sacramento, California, 95815, United States

Location

West Dermatology Research Center

San Diego, California, 92121, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Aeroallergy Research Laboratories of Savannah, Inc.

Savannah, Georgia, 31406, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

Southern Indiana Clinical Trials

New Albany, Indiana, 47150, United States

Location

Indiana Clinical Trials Center, P.C.

Plainfield, Indiana, 46168, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

Chesapeake Clinical Research, Inc

White Marsh, Maryland, 21162, United States

Location

OptiSkin Medical

New York, New York, 10128, United States

Location

Red River Research Partners

Fargo, North Dakota, 58013, United States

Location

Bexley Dermatology Research

Bexley, Ohio, 43209, United States

Location

Allergy, Asthma, and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Chronic Inducible Urticaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: August 14, 2024
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (18)