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

Phase 2

Recruiting

• Conditions: Chronic Spontaneous Urticaria
• Interventions: Drug: EVO756; Drug: Placebo control

• Registration Number: NCT06873516
• Lead Sponsor: Evommune, Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-11
• Study First Posted: 2025-03-12
• Study Start: 2025-03-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-05
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1	EVO756	Orally administered EVO756, dose 1
Dose 2	EVO756	Orally administered EVO756, dose 2
Dose 3	EVO756	Orally administered EVO756, dose 3
Placebo control	Placebo control	Orally administered placebo control

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in UAS7	Week 12

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in UAS7	Week 12
Mean and percent change from baseline in UAS7	Weeks 1, 2, 4, 8
Mean and percent change from baseline in HSS7	Weeks 1, 2, 4, 8, 12
Mean and percent change from baseline in ISS7	Weeks 1, 2, 4, 8, 12
Mean and percent change from baseline in AAS7	Weeks 1, 2, 4, 8, 12
Proportion of subjects achieving UAS7 ≤ 6	Weeks 1, 2, 4, 8, 12
Proportion of subjects achieving UAS7 = 0	Weeks 1, 2, 4, 8, 12

Trial Locations

Locations (41)

Cahaba Dermatology Skin Health Center; 🇺🇸 Birmingham, Alabama, United States

Velocity Clinical Research, Mobile; 🇺🇸 Mobile, Alabama, United States

Center for Dermatology Clinical Research; 🇺🇸 Fremont, California, United States

Antelope Valley Clinical Trials; 🇺🇸 Lancaster, California, United States

Northridge Clinical Trials; 🇺🇸 Northridge, California, United States

NorthBay Clinical Research; 🇺🇸 Santa Rosa, California, United States

Integrated Research of Inland; 🇺🇸 Upland, California, United States

FOMAT Medical Research; 🇺🇸 Ventura, California, United States

AMR Fort Myers; 🇺🇸 Fort Myers, Florida, United States

Sneeze, Wheeze & Itch Associates LLC; 🇺🇸 Normal, Illinois, United States

Scroll for more (31 remaining)