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

NCT06873516 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: EVO756-CSU001
• Study Type: interventional
• Target: 160
• Locations: 3 countries
• Sites: 53

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).

Conditions

Chronic Spontaneous Urticaria

Keywords

chronic spontaneous urticaria; CSU; chronic hives; hives; idiopathic urticaria; urticaria

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in UAS7

  Week 12

Secondary Outcomes (7)

• Percent change from baseline in UAS7

  Week 12

• Mean and percent change from baseline in UAS7

  Weeks 1, 2, 4, 8

• Mean and percent change from baseline in ISS7

  Weeks 1, 2, 4, 8, 12

• Mean and percent change from baseline in HSS7

  Weeks 1, 2, 4, 8, 12

• Mean and percent change from baseline in AAS7

  Weeks 1, 2, 4, 8, 12

Study Arms (4)

Dose 1

EXPERIMENTAL

Orally administered EVO756, dose 1

Drug: EVO756

Dose 2

EXPERIMENTAL

Orally administered EVO756, dose 2

Drug: EVO756

Dose 3

EXPERIMENTAL

Orally administered EVO756, dose 3

Drug: EVO756

Placebo control

PLACEBO COMPARATOR

Orally administered placebo control

Drug: Placebo control

Interventions

EVO756 DRUG

Dose 1

Dose 1

Placebo control DRUG

Placebo control

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evommune, Inc.: lead

Study Sites (53)

Cahaba Dermatology Skin Health Center

Birmingham, Alabama, 35244, United States

Location

Velocity Clinical Research, Mobile

Mobile, Alabama, 36608, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

Northridge Clinical Trials

Northridge, California, 91325, United States

Location

NorthBay Clinical Research

Santa Rosa, California, 95405, United States

Location

Integrated Research of Inland

Upland, California, 91786, United States

Location

FOMAT Medical Research

Ventura, California, 93003, United States

Location

AMR Fort Myers

Fort Myers, Florida, 33912, United States

Location

Advanced Clinical Research Institute

Tampa, Florida, 33607, United States

Location

Sneeze, Wheeze & Itch Associates LLC

Normal, Illinois, 61761, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Hutchinson Clinic

Hutchinson, Kansas, 67502, United States

Location

Bluegrass Allergy Care

Lexington, Kentucky, 40509, United States

Location

Delricht Research Louisville

Louisville, Kentucky, 40205, United States

Location

Delricht Research Louisiana

Baton Rouge, Louisiana, 70809, United States

Location

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, 70508, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Boston Specialists

Boston, Massachusetts, 02111, United States

Location

MI Skin Innovations

Northville, Michigan, 48167, United States

Location

DelRicht Research - Town Center Dermatology

Wildwood, Missouri, 63040, United States

Location

Vitality Clinical Trials

Woodbury, New York, 11797, United States

Location

Allergy Partners Clinical Research

Asheville, North Carolina, 28803, United States

Location

Delricht Research - Priority Care

Charlotte, North Carolina, 28205, United States

Location

Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Optima Research Boardman

Boardman, Ohio, 44512, United States

Location

DOCS Dermatology Research

Canal Winchester, Ohio, 43110, United States

Location

Bernstein Clinical Research Center

Cincinnati, Ohio, 45236, United States

Location

Toledo Institute of Clinical Research

Toledo, Ohio, 43617, United States

Location

AMR Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States

Location

National Allergy and Asthma Research

North Charleston, South Carolina, 29420, United States

Location

Delricht Research Smyrna

Smyrna, Tennessee, 37167, United States

Location

Austin Regional Clinic ARC Clinical Research

Austin, Texas, 78726, United States

Location

Studies in Dermatology

Cypress, Texas, 77429, United States

Location

Western Sky Medical Research

El Paso, Texas, 79912, United States

Location

Delricht Research - Lockhard Matter Dermatology

Prosper, Texas, 75078, United States

Location

AMR Utah

Layton, Utah, 84041, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98104, United States

Location

Allergy, Asthma, and Sinus Center

Greenfield, Wisconsin, 53228, United States

Location

Dandelion Allergy Centre

Mississauga, Ontario, L4W 5K3, Canada

Location

Allergy Research Canada

Niagara Falls, Ontario, L2H 1H5, Canada

Location

Red Maple Trials

Ottawa, Ontario, K1H 1E4, Canada

Location

Centre de Recherche Saint-Louis - Montréal

Montreal, Quebec, H1Y 3L1, Canada

Location

Centre de Recherche Saint-Louis

Québec, Quebec, G1W 4R4, Canada

Location

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, 5938324, Japan

Location

Yoshikawa Skin Clinic

Takatsuki, Osaka, 5690824, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, 5698686, Japan

Location

Mita Dermatology

Minato-Ku, Tokyo, 1080014, Japan

Location

ThinkPark Dermatology Clinic

Shinagawa-Ku, Tokyo, 1416003, Japan

Location

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, 1900023, Japan

Location

Ikebukuro Nishiguchi Fukurou Dermatology

Toshima-ku, Tokyo, 1710021, Japan

Location

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: March 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7); US (41); CA (5)