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

Launched by EVOMMUNE, INC. · Mar 11, 2025

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ClinConnect Summary

This clinical trial is looking at a new treatment called EVO756 for adults who have moderate to severe chronic spontaneous urticaria (CSU), a condition that causes itchy hives without a clear cause. The study aims to see how effective and safe different doses of EVO756 are for managing this condition. It is important to note that the trial is not yet recruiting participants, so if you're interested, you'll need to wait for it to start.

To be eligible for the trial, participants must have been diagnosed with CSU for at least three months and not have had enough relief from standard allergy medications called H1-antihistamines. Participants should also have a specific level of hives activity measured by a score called UAS7. However, people with certain medical issues or who are taking specific medications may not be able to join. If someone is accepted, they can expect to receive either EVO756 or a placebo (a substance with no active medicine) and will be monitored closely for any effects of the treatment.

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ALL

Eligibility 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.