RecruitingPhase 2NCT06873516

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

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


Sponsor

Evommune, Inc.

Enrollment

160 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

DRUGEVO756

Dose 1

DRUGEVO756

Dose 2

DRUGEVO756

Dose 3

DRUGPlacebo control

Placebo control


Locations(53)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, United States

Velocity Clinical Research, Mobile

Mobile, Alabama, United States

Center for Dermatology Clinical Research

Fremont, California, United States

Antelope Valley Clinical Trials

Lancaster, California, United States

Northridge Clinical Trials

Northridge, California, United States

NorthBay Clinical Research

Santa Rosa, California, United States

Integrated Research of Inland

Upland, California, United States

FOMAT Medical Research

Ventura, California, United States

AMR Fort Myers

Fort Myers, Florida, United States

Advanced Clinical Research Institute

Tampa, Florida, United States

Sneeze, Wheeze & Itch Associates LLC

Normal, Illinois, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

The Iowa Clinic

West Des Moines, Iowa, United States

Hutchinson Clinic

Hutchinson, Kansas, United States

Bluegrass Allergy Care

Lexington, Kentucky, United States

Delricht Research Louisville

Louisville, Kentucky, United States

Delricht Research Louisiana

Baton Rouge, Louisiana, United States

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, United States

Delricht Research

New Orleans, Louisiana, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Boston Specialists

Boston, Massachusetts, United States

MI Skin Innovations

Northville, Michigan, United States

DelRicht Research - Town Center Dermatology

Wildwood, Missouri, United States

Vitality Clinical Trials

Woodbury, New York, United States

Allergy Partners Clinical Research

Asheville, North Carolina, United States

Delricht Research - Priority Care

Charlotte, North Carolina, United States

Piedmont Healthcare

Statesville, North Carolina, United States

Optima Research Boardman

Boardman, Ohio, United States

DOCS Dermatology Research

Canal Winchester, Ohio, United States

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Toledo Institute of Clinical Research

Toledo, Ohio, United States

AMR Myrtle Beach

Myrtle Beach, South Carolina, United States

National Allergy and Asthma Research

North Charleston, South Carolina, United States

Delricht Research Smyrna

Smyrna, Tennessee, United States

Austin Regional Clinic ARC Clinical Research

Austin, Texas, United States

Studies in Dermatology

Cypress, Texas, United States

Western Sky Medical Research

El Paso, Texas, United States

Delricht Research - Lockhard Matter Dermatology

Prosper, Texas, United States

AMR Utah

Layton, Utah, United States

Seattle Clinical Research Center

Seattle, Washington, United States

Allergy, Asthma, and Sinus Center

Greenfield, Wisconsin, United States

Dandelion Allergy Centre

Mississauga, Ontario, Canada

Allergy Research Canada

Niagara Falls, Ontario, Canada

Red Maple Trials

Ottawa, Ontario, Canada

Centre de Recherche Saint-Louis - Montréal

Montreal, Quebec, Canada

Centre de Recherche Saint-Louis

Québec, Quebec, Canada

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, Japan

Yoshikawa Skin Clinic

Takatsuki, Osaka, Japan

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Mita Dermatology

Minato-Ku, Tokyo, Japan

ThinkPark Dermatology Clinic

Shinagawa-Ku, Tokyo, Japan

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, Japan

Ikebukuro Nishiguchi Fukurou Dermatology

Toshima-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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