A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
- Conditions
- Chronic Inducible Urticaria
- Interventions
- Drug: Oral EVO756
- Registration Number
- NCT06603220
- Lead Sponsor
- Evommune, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EVO756 Oral EVO756 -
- Primary Outcome Measures
Name Time Method Safety and tolerability Day 1 to Week 6 Safety will be assessed through an evaluation of treatment emergent adverse events, physical exams, vital signs, laboratory tests, and 12-lead ECGs.
- Secondary Outcome Measures
Name Time Method Change in Total Fric Score (TFS) Day 1 to Week 4 Changes in the number of prongs that elicit a wheal response using a FricTest for subjects with symptomatic dermographism.
Change in Critical Temperature Threshold (CTT) Day 1 to Week 4 Changes in the highest temperature that elicits a wheal response using a TempTest for subjects with cold urticaria.
Change in pruritus severity at the provocation test site Day 1 to Week 4 Changes in the severity of pruritus at the provocation test site using an 11-point numerical rating scale.
Trial Locations
- Locations (18)
Cahaba Dermatology & Skin Health Center, LLC
🇺🇸Birmingham, Alabama, United States
California Allergy and Asthma Medical Group
🇺🇸Los Angeles, California, United States
Integrative Skin Science and Research
🇺🇸Sacramento, California, United States
West Dermatology Research Center
🇺🇸San Diego, California, United States
Advanced Clinical Research Institute
🇺🇸Tampa, Florida, United States
Aeroallergy Research Laboratories of Savannah, Inc.
🇺🇸Savannah, Georgia, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
🇺🇸New Albany, Indiana, United States
Indiana Clinical Trials Center, P.C.
🇺🇸Plainfield, Indiana, United States
DelRicht Research
🇺🇸Baton Rouge, Louisiana, United States
Chesapeake Clinical Research, Inc
🇺🇸White Marsh, Maryland, United States
OptiSkin Medical
🇺🇸New York, New York, United States
Red River Research Partners
🇺🇸Fargo, North Dakota, United States
Bexley Dermatology Research
🇺🇸Bexley, Ohio, United States
Allergy, Asthma, and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Austin Institute for Clinical Research
🇺🇸Pflugerville, Texas, United States