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Evaluating EVO756 for treating chronic hives in adults

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

PHASE2 · Evommune, Inc. · NCT06873516

This study is testing a new treatment called EVO756 to see if it can help adults with moderate to severe chronic hives who haven't found relief with standard medications.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
SponsorEvommune, Inc. (industry)
Locations26 sites (Birmingham, Alabama and 25 other locations)
Trial IDNCT06873516 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of various doses of EVO756 in adults suffering from moderate to severe chronic spontaneous urticaria (CSU). Participants must have a confirmed diagnosis of CSU for at least three months and have shown inadequate response to standard H1-antihistamines. The study will involve a placebo control group to compare the effects of the treatment. The primary measure of effectiveness will be the Urticaria Activity Score (UAS7), which evaluates the severity of hives over a week.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with moderate to severe chronic spontaneous urticaria who have not adequately responded to H1-antihistamines.

Not a fit: Patients with other significant medical conditions or those who have a history of diseases causing urticaria or angioedema may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief for patients suffering from chronic spontaneous urticaria who have not responded to existing therapies.

How similar studies have performed: While there have been studies on treatments for chronic spontaneous urticaria, the specific approach with EVO756 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Spontaneous Urticaria, chronic spontaneous urticaria, CSU, chronic hives, hives, idiopathic urticaria, urticaria

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.