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Chronic Spontaneous UrticariaPhase 2NCT06873516

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

A Phase 2 study testing EVO756 in people with Chronic Spontaneous Urticaria, run by Evommune, Inc. at 53 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Spontaneous Urticaria
What is being tested?
EVO756
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
53 sitesin 3 countries
Study dates
20 Mar 2025to 5 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

53 sites in 3 countries.

53 sites in 3 countries

United States41 sites

  • Allergy Partners Clinical Research

    Asheville, North Carolina, 28803

  • Austin Regional Clinic ARC Clinical Research

    Austin, Texas, 78726

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Delricht Research Louisiana

    Baton Rouge, Louisiana, 70809

  • Cahaba Dermatology Skin Health Center

    Birmingham, Alabama, 35244

  • Optima Research Boardman

    Boardman, Ohio, 44512

  • Boston Specialists

    Boston, Massachusetts, 02111

  • DOCS Dermatology Research

    Canal Winchester, Ohio, 43110

  • Delricht Research - Priority Care

    Charlotte, North Carolina, 28205

  • Bernstein Clinical Research Center

    Cincinnati, Ohio, 45236

  • Studies in Dermatology

    Cypress, Texas, 77429

  • Western Sky Medical Research

    El Paso, Texas, 79912

  • AMR Fort Myers

    Fort Myers, Florida, 33912

  • Center for Dermatology Clinical Research

    Fremont, California, 94538

  • Allergy, Asthma, and Sinus Center

    Greenfield, Wisconsin, 53228

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

  • Velocity Clinical Research, Lafayette

    Lafayette, Louisiana, 70508

  • Antelope Valley Clinical Trials

    Lancaster, California, 93534

  • AMR Utah

    Layton, Utah, 84041

  • Bluegrass Allergy Care

    Lexington, Kentucky, 40509

  • Delricht Research Louisville

    Louisville, Kentucky, 40205

  • Velocity Clinical Research, Mobile

    Mobile, Alabama, 36608

  • AMR Myrtle Beach

    Myrtle Beach, South Carolina, 29572

  • Delricht Research

    New Orleans, Louisiana, 70115

  • Sneeze, Wheeze & Itch Associates LLC

    Normal, Illinois, 61761

  • National Allergy and Asthma Research

    North Charleston, South Carolina, 29420

  • Northridge Clinical Trials

    Northridge, California, 91325

  • MI Skin Innovations

    Northville, Michigan, 48167

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168

  • Delricht Research - Lockhard Matter Dermatology

    Prosper, Texas, 75078

  • NorthBay Clinical Research

    Santa Rosa, California, 95405

  • Seattle Clinical Research Center

    Seattle, Washington, 98104

  • Delricht Research Smyrna

    Smyrna, Tennessee, 37167

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Advanced Clinical Research Institute

    Tampa, Florida, 33607

  • Toledo Institute of Clinical Research

    Toledo, Ohio, 43617

  • Integrated Research of Inland

    Upland, California, 91786

  • FOMAT Medical Research

    Ventura, California, 93003

  • The Iowa Clinic

    West Des Moines, Iowa, 50266

  • DelRicht Research - Town Center Dermatology

    Wildwood, Missouri, 63040

  • Vitality Clinical Trials

    Woodbury, New York, 11797

Other trials in United States

Japan7 sites

  • Mita Dermatology

    Minato-Ku, Tokyo, 1080014

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 5938324

  • ThinkPark Dermatology Clinic

    Shinagawa-Ku, Tokyo, 1416003

  • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic

    Tachikawa, Tokyo, 1900023

  • Yoshikawa Skin Clinic

    Takatsuki, Osaka, 5690824

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, Osaka, 5698686

  • Ikebukuro Nishiguchi Fukurou Dermatology

    Toshima-ku, Tokyo, 1710021

Other trials in Japan

Canada5 sites

  • Dandelion Allergy Centre

    Mississauga, Ontario, L4W 5K3

  • Centre de Recherche Saint-Louis - Montréal

    Montreal, Quebec, H1Y 3L1

  • Allergy Research Canada

    Niagara Falls, Ontario, L2H 1H5

  • Red Maple Trials

    Ottawa, Ontario, K1H 1E4

  • Centre de Recherche Saint-Louis

    Québec, Quebec, G1W 4R4

Other trials in Canada

About this study

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

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

Being tested
EVO756, Placebo control
Keywords
chronic spontaneous urticaria, CSU, chronic hives, hives, idiopathic urticaria, urticaria
Medical subject headings
Chronic Urticaria, Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EVO756Drug

    Dose 1

  • EVO756Drug

    Dose 2

  • EVO756Drug

    Dose 3

  • Placebo controlDrug

    Placebo control

Study groups in NCT06873516
Study groupRoleWhat they receive
Dose 1ExperimentalOrally administered EVO756, dose 1
Receives: Drug: EVO756
Dose 2ExperimentalOrally administered EVO756, dose 2
Receives: Drug: EVO756
Dose 3ExperimentalOrally administered EVO756, dose 3
Receives: Drug: EVO756
Placebo controlPlacebo comparatorOrally administered placebo control
Receives: Drug: Placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in UAS7

    Measured: Week 12

Secondary outcomes (7)

  1. Percent change from baseline in UAS7

    Measured: Week 12

  2. Mean and percent change from baseline in UAS7

    Measured: Weeks 1, 2, 4, 8

  3. Mean and percent change from baseline in ISS7

    Measured: Weeks 1, 2, 4, 8, 12

  4. Mean and percent change from baseline in HSS7

    Measured: Weeks 1, 2, 4, 8, 12

  5. Mean and percent change from baseline in AAS7

    Measured: Weeks 1, 2, 4, 8, 12

  6. Proportion of subjects achieving UAS7 ≤ 6

    Measured: Weeks 1, 2, 4, 8, 12

  7. Proportion of subjects achieving UAS7 = 0

    Measured: Weeks 1, 2, 4, 8, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start20 Mar 2025
  3. Primary completion29 May 2026
  4. Study completion5 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873516
Sponsor's protocol ID
EVO756-CSU001
Status last verified
Jun 2026
First submitted
7 Mar 2025
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EVO756 in people with Chronic Spontaneous Urticaria, run by Evommune, Inc. at 53 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Japan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in UAS7 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06873516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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