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

June 29, 2026 updated by: Evommune, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4W 5K3
        • Dandelion Allergy Centre
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • Allergy Research Canada
      • Ottawa, Ontario, Canada, K1H 1E4
        • Red Maple Trials
    • Quebec
      • Montreal, Quebec, Canada, H1Y 3L1
        • Centre de Recherche Saint-Louis - Montréal
      • Québec, Quebec, Canada, G1W 4R4
        • Centre de Recherche Saint-Louis
  • Japan
    • Osaka
      • Sakai, Osaka, Japan, 5938324
        • Dermatology and Ophthalmology Kume Clinic
      • Takatsuki, Osaka, Japan, 5690824
        • Yoshikawa Skin Clinic
      • Takatsuki, Osaka, Japan, 5698686
        • Osaka Medical and Pharmaceutical University Hospital
    • Tokyo
      • Minato-Ku, Tokyo, Japan, 1080014
        • Mita Dermatology
      • Shinagawa-Ku, Tokyo, Japan, 1416003
        • ThinkPark Dermatology Clinic
      • Tachikawa, Tokyo, Japan, 1900023
        • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
      • Toshima-ku, Tokyo, Japan, 1710021
        • Ikebukuro Nishiguchi Fukurou Dermatology
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology Skin Health Center
      • Mobile, Alabama, United States, 36608
        • Velocity Clinical Research, Mobile
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research
      • Lancaster, California, United States, 93534
        • Antelope Valley Clinical Trials
      • Northridge, California, United States, 91325
        • Northridge Clinical Trials
      • Santa Rosa, California, United States, 95405
        • NorthBay Clinical Research
      • Upland, California, United States, 91786
        • Integrated Research of Inland
      • Ventura, California, United States, 93003
        • Fomat Medical Research
    • Florida
      • Fort Myers, Florida, United States, 33912
        • AMR Fort Myers
      • Tampa, Florida, United States, 33607
        • Advanced Clinical Research Institute
    • Illinois
      • Normal, Illinois, United States, 61761
        • Sneeze, Wheeze & Itch Associates LLC
    • Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Bluegrass Allergy Care
      • Louisville, Kentucky, United States, 40205
        • Delricht Research Louisville
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Delricht Research Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Velocity Clinical Research, Lafayette
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Boston Specialists
    • Michigan
      • Northville, Michigan, United States, 48167
        • MI Skin Innovations
    • Missouri
      • Wildwood, Missouri, United States, 63040
        • DelRicht Research - Town Center Dermatology
    • New York
      • Woodbury, New York, United States, 11797
        • Vitality Clinical Trials
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Allergy Partners Clinical Research
      • Charlotte, North Carolina, United States, 28205
        • Delricht Research - Priority Care
      • Statesville, North Carolina, United States, 28625
        • Piedmont Healthcare
    • Ohio
      • Boardman, Ohio, United States, 44512
        • Optima Research Boardman
      • Canal Winchester, Ohio, United States, 43110
        • DOCS Dermatology Research
      • Cincinnati, Ohio, United States, 45236
        • Bernstein Clinical Research Center
      • Toledo, Ohio, United States, 43617
        • Toledo Institute of Clinical Research
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • AMR Myrtle Beach
      • North Charleston, South Carolina, United States, 29420
        • National Allergy and Asthma Research
    • Tennessee
      • Smyrna, Tennessee, United States, 37167
        • Delricht Research Smyrna
    • Texas
      • Austin, Texas, United States, 78726
        • Austin Regional Clinic ARC Clinical Research
      • Cypress, Texas, United States, 77429
        • Studies in Dermatology
      • El Paso, Texas, United States, 79912
        • Western Sky Medical Research
      • Prosper, Texas, United States, 75078
        • Delricht Research - Lockhard Matter Dermatology
    • Utah
      • Layton, Utah, United States, 84041
        • AMR Utah
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle Clinical Research Center
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Allergy, Asthma, and Sinus Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1
Orally administered EVO756, dose 1
Drug: EVO756
Dose 1
Drug: EVO756
Dose 2
Drug: EVO756
Dose 3
Experimental: Dose 2
Orally administered EVO756, dose 2
Drug: EVO756
Dose 1
Drug: EVO756
Dose 2
Drug: EVO756
Dose 3
Experimental: Dose 3
Orally administered EVO756, dose 3
Drug: EVO756
Dose 1
Drug: EVO756
Dose 2
Drug: EVO756
Dose 3
Placebo Comparator: Placebo control
Orally administered placebo control
Drug: Placebo control
Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in UAS7
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in UAS7
Time Frame: Week 12
Week 12
Mean and percent change from baseline in UAS7
Time Frame: Weeks 1, 2, 4, 8
Weeks 1, 2, 4, 8
Mean and percent change from baseline in ISS7
Time Frame: Weeks 1, 2, 4, 8, 12
Weeks 1, 2, 4, 8, 12
Mean and percent change from baseline in HSS7
Time Frame: Weeks 1, 2, 4, 8, 12
Weeks 1, 2, 4, 8, 12
Mean and percent change from baseline in AAS7
Time Frame: Weeks 1, 2, 4, 8, 12
Weeks 1, 2, 4, 8, 12
Proportion of subjects achieving UAS7 ≤ 6
Time Frame: Weeks 1, 2, 4, 8, 12
Weeks 1, 2, 4, 8, 12
Proportion of subjects achieving UAS7 = 0
Time Frame: Weeks 1, 2, 4, 8, 12
Weeks 1, 2, 4, 8, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evommune, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Actual)

May 29, 2026

Study Completion (Actual)

June 5, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVO756-CSU001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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