Clinical trial NCT06603220: A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
Official title: An Open Label Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Inducible Urticaria
Keywords: chronic inducible urticaria
inducible urticaria
Lead sponsor: Evommune, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: Day 1 to Week 6
Secondary outcomes:
measure: Change in Total Fric Score (TFS)
timeFrame: Day 1 to Week 4
measure: Change in Critical Temperature Threshold (CTT)
timeFrame: Day 1 to Week 4
measure: Change in pruritus severity at the provocation test site
timeFrame: Day 1 to Week 4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center, LLC
state: Alabama
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: San Diego
country: United States
facility: West Dermatology Research Center
state: California
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Savannah
country: United States
facility: Aeroallergy Research Laboratories of Savannah, Inc.
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: Southern Indiana Clinical Trials
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trials Center, P.C.
state: Indiana
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc
state: Maryland
city: New York
country: United States
facility: OptiSkin Medical
state: New York
city: Fargo
country: United States
facility: Red River Research Partners
state: North Dakota
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma, and Clinical Research Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
Study officials:
References: