Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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
Related Research Topics
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Trial Locations
- Locations (26)
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
Integrated Research of Inland
🇺🇸Upland, California, United States
FOMAT Medical Research
🇺🇸Ventura, California, United States
AMR Fort Myers
🇺🇸Fort Myers, Florida, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Delricht Research Louisville
🇺🇸Louisville, Kentucky, United States
Velocity Clinical Research, Lafayette
🇺🇸Lafayette, Louisiana, United States
Boston Specialists
🇺🇸Boston, Massachusetts, United States
Delricht Research - Priority Care
🇺🇸Charlotte, North Carolina, United States
Toledo Institute of Clinical Research
🇺🇸Toledo, Ohio, United States
AMR Myrtle Beach
🇺🇸Myrtle Beach, South Carolina, United States
National Allergy and Asthma Research
🇺🇸North Charleston, South Carolina, United States
Delricht Research Smyrna
🇺🇸Smyrna, Tennessee, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Delricht Research - Lockhard Matter Dermatology
🇺🇸Prosper, Texas, United States
Allergy, Asthma, and Sinus Center
🇺🇸Greenfield, Wisconsin, United States
Bluegrass Allergy Care
🇺🇸Lexington, Kentucky, United States
Delricht Research Louisiana
🇺🇸Baton Rouge, Louisiana, United States
Delricht Research
🇺🇸New Orleans, Louisiana, United States
Studies in Dermatology
🇺🇸Cypress, Texas, United States
AMR Utah
🇺🇸Layton, Utah, United States
Seattle Clinical Research Center
🇺🇸Seattle, Washington, United States