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

NCT ID: NCT06873516

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Spontaneous Urticaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1

Orally administered EVO756, dose 1

Group Type EXPERIMENTAL

EVO756

Intervention Type DRUG

Dose 1

Dose 2

Orally administered EVO756, dose 2

Group Type EXPERIMENTAL

EVO756

Intervention Type DRUG

Dose 2

Dose 3

Orally administered EVO756, dose 3

Group Type EXPERIMENTAL

EVO756

Intervention Type DRUG

Dose 3

Placebo control

Orally administered placebo control

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DRUG

Placebo control

Interventions

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EVO756

Dose 3

Intervention Type DRUG

Placebo control

Placebo control

Intervention Type DRUG

EVO756

Dose 1

Intervention Type DRUG

EVO756

Dose 2

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evommune, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cahaba Dermatology Skin Health Center

Birmingham, Alabama, United States

Site Status RECRUITING

Velocity Clinical Research, Mobile

Mobile, Alabama, United States

Site Status RECRUITING

Center for Dermatology Clinical Research

Fremont, California, United States

Site Status RECRUITING

Antelope Valley Clinical Trials

Lancaster, California, United States

Site Status RECRUITING

Northridge Clinical Trials

Northridge, California, United States

Site Status RECRUITING

NorthBay Clinical Research

Santa Rosa, California, United States

Site Status RECRUITING

Integrated Research of Inland

Upland, California, United States

Site Status RECRUITING

FOMAT Medical Research

Ventura, California, United States

Site Status RECRUITING

AMR Fort Myers

Fort Myers, Florida, United States

Site Status COMPLETED

Advanced Clinical Research Institute

Tampa, Florida, United States

Site Status RECRUITING

Sneeze, Wheeze & Itch Associates LLC

Normal, Illinois, United States

Site Status RECRUITING

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status RECRUITING

The Iowa Clinic

West Des Moines, Iowa, United States

Site Status RECRUITING

Hutchinson Clinic

Hutchinson, Kansas, United States

Site Status RECRUITING

Bluegrass Allergy Care

Lexington, Kentucky, United States

Site Status RECRUITING

Delricht Research Louisville

Louisville, Kentucky, United States

Site Status COMPLETED

Delricht Research Louisiana

Baton Rouge, Louisiana, United States

Site Status COMPLETED

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, United States

Site Status COMPLETED

Delricht Research

New Orleans, Louisiana, United States

Site Status RECRUITING

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Boston Specialists

Boston, Massachusetts, United States

Site Status RECRUITING

MI Skin Innovations

Northville, Michigan, United States

Site Status COMPLETED

DelRicht Research - Town Center Dermatology

Wildwood, Missouri, United States

Site Status RECRUITING

Vitality Clinical Trials

Woodbury, New York, United States

Site Status RECRUITING

Allergy Partners Clinical Research

Asheville, North Carolina, United States

Site Status RECRUITING

Delricht Research - Priority Care

Charlotte, North Carolina, United States

Site Status COMPLETED

Piedmont Healthcare

Statesville, North Carolina, United States

Site Status RECRUITING

Optima Research Boardman

Boardman, Ohio, United States

Site Status RECRUITING

DOCS Dermatology Research

Canal Winchester, Ohio, United States

Site Status RECRUITING

Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Toledo Institute of Clinical Research

Toledo, Ohio, United States

Site Status RECRUITING

AMR Myrtle Beach

Myrtle Beach, South Carolina, United States

Site Status COMPLETED

National Allergy and Asthma Research

North Charleston, South Carolina, United States

Site Status RECRUITING

Delricht Research Smyrna

Smyrna, Tennessee, United States

Site Status RECRUITING

Austin Regional Clinic ARC Clinical Research

Austin, Texas, United States

Site Status RECRUITING

Studies in Dermatology

Cypress, Texas, United States

Site Status RECRUITING

Western Sky Medical Research

El Paso, Texas, United States

Site Status RECRUITING

Delricht Research - Lockhard Matter Dermatology

Prosper, Texas, United States

Site Status COMPLETED

AMR Utah

Layton, Utah, United States

Site Status COMPLETED

Seattle Clinical Research Center

Seattle, Washington, United States

Site Status RECRUITING

Allergy, Asthma, and Sinus Center

Greenfield, Wisconsin, United States

Site Status RECRUITING

Dandelion Allergy Centre

Mississauga, Ontario, Canada

Site Status RECRUITING

Allergy Research Canada

Niagara Falls, Ontario, Canada

Site Status RECRUITING

Red Maple Trials

Ottawa, Ontario, Canada

Site Status RECRUITING

Centre de Recherche Saint-Louis - Montréal

Montreal, Quebec, Canada

Site Status RECRUITING

Centre de Recherche Saint-Louis

Québec, Quebec, Canada

Site Status RECRUITING

Dermatology and Ophthalmology Kume Clinic

Sakai, Osaka, Japan

Site Status RECRUITING

Yoshikawa Skin Clinic

Takatsuki, Osaka, Japan

Site Status RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

Site Status COMPLETED

Mita Dermatology

Minato-Ku, Tokyo, Japan

Site Status COMPLETED

ThinkPark Dermatology Clinic

Shinagawa-Ku, Tokyo, Japan

Site Status COMPLETED

Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

Tachikawa, Tokyo, Japan

Site Status RECRUITING

Ikebukuro Nishiguchi Fukurou Dermatology

Toshima-ku, Tokyo, Japan

Site Status RECRUITING

Countries

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United States Canada Japan

Central Contacts

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Polina Bukshpun

Role: CONTACT

+1-818-536-2358

Facility Contacts

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Vlada Groysman

Role: primary

205-214-7546

Lawrence Sindel

Role: primary

251-263-5669

Sunil Dhawan

Role: primary

5107974111

Ricardo Tan

Role: primary

661-266-8944

Navid Ezra

Role: primary

(818) 350-7483

Julie Plante

Role: primary

707-542-2783

Heena Shah-Patel

Role: primary

951-781-7199

Preeti Chopra

Role: primary

805-483-1185

Francis Caban

Role: primary

813-879-7546

Dareen Siri

Role: primary

309-452-0995

Mitchell Smith

Role: primary

3178376082

Jennifer Petts

Role: primary

(515) 875-9260

James Ruhlmann

Role: primary

620-669-2500

William Greisner

Role: primary

859-303-7191

Deirdre Hooper

Role: primary

(504) 336-2667

Sarbjit Saini

Role: primary

410-550-2129

John Leung

Role: primary

617-804-6767

Christopher Kling

Role: primary

314-788-3360

Jeffrey Sklar

Role: primary

917-647-3830

David Cypcar

Role: primary

828-348-7047

Dwight Bellingham

Role: primary

704-660-1231

Patrick Shannon

Role: primary

317-837-6082

Shannon Trotter

Role: primary

614-524-4146

Jonathan Bernstein

Role: primary

513-931-0775

Syed Rehman

Role: primary

6316017155

John Ramey

Role: primary

8435763382

Pezhman Shoureshi

Role: primary

5043362667

Hetu Parekh

Role: primary

(512) 250-5571

Lauren Campbell

Role: primary

(281) 377-6665

Todd Funkhouser

Role: primary

915-544-2557

Sonja Krejci

Role: primary

(206) 522-3330

Gary Steven

Role: primary

414-529-8519

Mondeesh Sidhu

Role: primary

647-456-2808

Vipul Jain

Role: primary

289-241-0577

William Yang

Role: primary

613-368-4320

Catherine Tremblay

Role: primary

418 780-3501

Virginie Kelly

Role: primary

418-780-3501

Akihiro Kume

Role: primary

+81-72-260-1241

Takeshi Yoshikawa

Role: primary

+81-72-694-2636

Hideki Ito

Role: primary

+81-42-843-1377

Tomoko Fujimoto

Role: primary

+81-3-3590-2960

Other Identifiers

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EVO756-CSU001

Identifier Type: -

Identifier Source: org_study_id

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