Clinical trial NCT06873516: Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)
Official title: A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Keywords: chronic spontaneous urticaria
CSU
chronic hives
hives
idiopathic urticaria
urticaria
Lead sponsor: Evommune, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).


Eligibility criteria: Inclusion Criteria:

* Confirmed CSU diagnosis for at least 3 months with an inadequate response to H1-antihistamines.
* Subjects who are taking H1-antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study.
* Urticaria Activity Score (UAS7) equal to or greater than 16 at Day 1. UAS entries must be completed for a minimum of 4 out of the 7 days prior to Day 1.

Exclusion Criteria:

* Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening, according to the Investigator's discretion.
* Use of certain medications.
* History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism.
* Significant medical history other than CSU, or any other condition which might interfere with the evaluation of CSU.

Primary outcomes:
measure: Mean change from baseline in UAS7
timeFrame: Week 12
Secondary outcomes:
measure: Percent change from baseline in UAS7
timeFrame: Week 12
measure: Mean and percent change from baseline in UAS7
timeFrame: Weeks 1, 2, 4, 8
measure: Mean and percent change from baseline in ISS7
timeFrame: Weeks 1, 2, 4, 8, 12
measure: Mean and percent change from baseline in HSS7
timeFrame: Weeks 1, 2, 4, 8, 12
measure: Mean and percent change from baseline in AAS7
timeFrame: Weeks 1, 2, 4, 8, 12
measure: Proportion of subjects achieving UAS7 ≤ 6
timeFrame: Weeks 1, 2, 4, 8, 12
measure: Proportion of subjects achieving UAS7 = 0
timeFrame: Weeks 1, 2, 4, 8, 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology Skin Health Center
state: Alabama
city: Mobile
country: United States
facility: Velocity Clinical Research, Mobile
state: Alabama
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Santa Rosa
country: United States
facility: NorthBay Clinical Research
state: California
city: Upland
country: United States
facility: Integrated Research of Inland
state: California
city: Ventura
country: United States
facility: FOMAT Medical Research
state: California
city: Fort Myers
country: United States
facility: AMR Fort Myers
state: Florida
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates LLC
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Lexington
country: United States
facility: Bluegrass Allergy Care
state: Kentucky
city: Louisville
country: United States
facility: Delricht Research Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Delricht Research Louisiana
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research, Lafayette
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Boston
country: United States
facility: Boston Specialists
state: Massachusetts
city: Northville
country: United States
facility: MI Skin Innovations
state: Michigan
city: Wildwood
country: United States
facility: DelRicht Research - Town Center Dermatology
state: Missouri
city: Woodbury
country: United States
facility: Vitality Clinical Trials
state: New York
city: Asheville
country: United States
facility: Allergy Partners Clinical Research
state: North Carolina
city: Charlotte
country: United States
facility: Delricht Research - Priority Care
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Bexley
country: United States
facility: DOCS Dermatology Research
state: Ohio
city: Boardman
country: United States
facility: Optima Research Boardman
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research
state: Ohio
city: Myrtle Beach
country: United States
facility: AMR Myrtle Beach
state: South Carolina
city: North Charleston
country: United States
facility: National Allergy and Asthma Research
state: South Carolina
city: Smyrna
country: United States
facility: Delricht Research Smyrna
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic ARC Clinical Research
state: Texas
city: Cypress
country: United States
facility: Studies in Dermatology
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Prosper
country: United States
facility: Delricht Research - Lockhard Matter Dermatology
state: Texas
city: Layton
country: United States
facility: AMR Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Greenfield
country: United States
facility: Allergy, Asthma, and Sinus Center
state: Wisconsin
city: Mississauga
country: Canada
facility: Dandelion Allergy Centre
state: Ontario
city: Niagara Falls
country: Canada
facility: Allergy Research Canada
state: Ontario
city: Ottawa
country: Canada
facility: Red Maple Trials
state: Ontario
Study officials:
References: