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NCT Number: NCT06873516

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dandelion Allergy Centre, Mississauga, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVO756

Drug

Dose 1

Placebo Control

Drug

Placebo control

Primary outcomes

  1. Mean change from baseline in UAS7

    Time frame: Week 12

Secondary outcomes

  1. Percent change from baseline in UAS7

    Time frame: Week 12

  2. Mean and percent change from baseline in UAS7

    Time frame: Weeks 1, 2, 4, 8

  3. Mean and percent change from baseline in ISS7

    Time frame: Weeks 1, 2, 4, 8, 12

  4. Mean and percent change from baseline in HSS7

    Time frame: Weeks 1, 2, 4, 8, 12

  5. Mean and percent change from baseline in AAS7

    Time frame: Weeks 1, 2, 4, 8, 12

  6. Proportion of subjects achieving UAS7 ≤ 6

    Time frame: Weeks 1, 2, 4, 8, 12

  7. Proportion of subjects achieving UAS7 = 0

    Time frame: Weeks 1, 2, 4, 8, 12

Sponsors and collaborators

Lead sponsor

Evommune, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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