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Clinical Trial NCT06873516 for Chronic Spontaneous Urticaria is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU) Phase 2 160
Clinical Trial NCT06873516 is designed to study Treatment for Chronic Spontaneous Urticaria. It is a Phase 2 interventional study that is recruiting, having started on 20 March 2025, with plans to enroll 160 participants. Led by Evommune, Inc., it is expected to complete by 1 May 2026. The latest data from ClinicalTrials.gov was last updated on 21 January 2026.
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).
Official 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
Conditions
Chronic Spontaneous UrticariaOther Study IDs
- EVO756-CSU001
NCT ID Number
Start Date (Actual)
2025-03-20
Last Update Posted
2026-01-21
Completion Date (Estimated)
2026-05
Enrollment (Estimated)
160
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
chronic spontaneous urticaria
CSU
chronic hives
hives
idiopathic urticaria
urticaria
CSU
chronic hives
hives
idiopathic urticaria
urticaria
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDose 1 Orally administered EVO756, dose 1 | EVO756 Dose 1 |
ExperimentalDose 2 Orally administered EVO756, dose 2 | EVO756 Dose 2 |
ExperimentalDose 3 Orally administered EVO756, dose 3 | EVO756 Dose 3 |
Placebo ComparatorPlacebo control Orally administered placebo control | Placebo control Placebo control |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean change from baseline in UAS7 | Week 12 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 ISS7 | Weeks 1, 2, 4, 8, 12 | |
Mean and percent change from baseline in HSS7 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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 Central Contact
Contact: Polina Bukshpun, +1-818-536-2358, [email protected]
53 Study Locations in 3 Countries
Alabama
Cahaba Dermatology Skin Health Center, Birmingham, Alabama, 35244, United States
Vlada Groysman, Contact, 205-214-7546, [email protected]
Recruiting
Velocity Clinical Research, Mobile, Mobile, Alabama, 36608, United States
Lawrence Sindel, Contact, 251-263-5669, [email protected]
Recruiting
California
Center for Dermatology Clinical Research, Fremont, California, 94538, United States
Sunil Dhawan, Contact, 5107974111, [email protected]
Recruiting
Antelope Valley Clinical Trials, Lancaster, California, 93534, United States
Ricardo Tan, Contact, 661-266-8944, [email protected]
Recruiting
Northridge Clinical Trials, Northridge, California, 91325, United States
Navid Ezra, Contact, (818) 350-7483, [email protected]
Recruiting
NorthBay Clinical Research, Santa Rosa, California, 95405, United States
Julie Plante, Contact, 707-542-2783, [email protected]
Recruiting
Integrated Research of Inland, Upland, California, 91786, United States
Heena Shah-Patel, Contact, 951-781-7199, [email protected]
Recruiting
FOMAT Medical Research, Ventura, California, 93003, United States
Preeti Chopra, Contact, 805-483-1185, [email protected]
Recruiting
Florida
AMR Fort Myers, Fort Myers, Florida, 33912, United States
Completed
Advanced Clinical Research Institute, Tampa, Florida, 33607, United States
Francis Caban, Contact, 813-879-7546, [email protected]
Recruiting
Illinois
Sneeze, Wheeze & Itch Associates LLC, Normal, Illinois, 61761, United States
Dareen Siri, Contact, 309-452-0995, [email protected]
Recruiting
Indiana
The Indiana Clinical Trials Center, Plainfield, Indiana, 46168, United States
Mitchell Smith, Contact, 3178376082, [email protected]
Recruiting
Iowa
The Iowa Clinic, West Des Moines, Iowa, 50266, United States
Jennifer Petts, Contact, (515) 875-9260, [email protected]
Recruiting
Kansas
Hutchinson Clinic, Hutchinson, Kansas, 67502, United States
James Ruhlmann, Contact, 620-669-2500, [email protected]
Recruiting
Kentucky
Bluegrass Allergy Care, Lexington, Kentucky, 40509, United States
William Greisner, Contact, 859-303-7191, [email protected]
Recruiting
Delricht Research Louisville, Louisville, Kentucky, 40205, United States
Completed
Louisiana
Delricht Research Louisiana, Baton Rouge, Louisiana, 70809, United States
Completed
Velocity Clinical Research, Lafayette, Lafayette, Louisiana, 70508, United States
Completed
Delricht Research, New Orleans, Louisiana, 70115, United States
Deirdre Hooper, Contact, (504) 336-2667, [email protected]
Recruiting
Maryland
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, 21224, United States
Sarbjit Saini, Contact, 410-550-2129, [email protected]
Recruiting
Massachusetts
Boston Specialists, Boston, Massachusetts, 02111, United States
John Leung, Contact, 617-804-6767, [email protected]
Recruiting
Michigan
MI Skin Innovations, Northville, Michigan, 48167, United States
Completed
Missouri
DelRicht Research - Town Center Dermatology, Wildwood, Missouri, 63040, United States
Christopher Kling, Contact, 314-788-3360, [email protected]
Recruiting
New York
Vitality Clinical Trials, Woodbury, New York, 11797, United States
Jeffrey Sklar, Contact, 917-647-3830, [email protected]
Recruiting
North Carolina
Allergy Partners Clinical Research, Asheville, North Carolina, 28803, United States
David Cypcar, Contact, 828-348-7047, [email protected]
Recruiting
Delricht Research - Priority Care, Charlotte, North Carolina, 28205, United States
Completed
Piedmont Healthcare, Statesville, North Carolina, 28625, United States
Dwight Bellingham, Contact, 704-660-1231, [email protected]
Recruiting
Ohio
Optima Research Boardman, Boardman, Ohio, 44512, United States
Patrick Shannon, Contact, 317-837-6082, [email protected]
Recruiting
DOCS Dermatology Research, Canal Winchester, Ohio, 43110, United States
Shannon Trotter, Contact, 614-524-4146, [email protected]
Recruiting
Bernstein Clinical Research Center, Cincinnati, Ohio, 45236, United States
Jonathan Bernstein, Contact, 513-931-0775, [email protected]
Recruiting
Toledo Institute of Clinical Research, Toledo, Ohio, 43617, United States
Syed Rehman, Contact, 6316017155, [email protected]
Recruiting
South Carolina
AMR Myrtle Beach, Myrtle Beach, South Carolina, 29572, United States
Completed
National Allergy and Asthma Research, North Charleston, South Carolina, 29420, United States
John Ramey, Contact, 8435763382, [email protected]
Recruiting
Tennessee
Delricht Research Smyrna, Smyrna, Tennessee, 37167, United States
Pezhman Shoureshi, Contact, 5043362667, [email protected]
Recruiting
Texas
Austin Regional Clinic ARC Clinical Research, Austin, Texas, 78726, United States
Hetu Parekh, Contact, (512) 250-5571, [email protected]
Recruiting
Studies in Dermatology, Cypress, Texas, 77429, United States
Lauren Campbell, Contact, (281) 377-6665, [email protected]
Recruiting
Western Sky Medical Research, El Paso, Texas, 79912, United States
Todd Funkhouser, Contact, 915-544-2557, [email protected]
Recruiting
Delricht Research - Lockhard Matter Dermatology, Prosper, Texas, 75078, United States
Completed
Utah
AMR Utah, Layton, Utah, 84041, United States
Completed
Washington
Seattle Clinical Research Center, Seattle, Washington, 98104, United States
Sonja Krejci, Contact, (206) 522-3330, [email protected]
Recruiting
Wisconsin
Allergy, Asthma, and Sinus Center, Greenfield, Wisconsin, 53228, United States
Gary Steven, Contact, 414-529-8519, [email protected]
Recruiting
Ontario
Dandelion Allergy Centre, Mississauga, Ontario, L4W 5K3, Canada
Mondeesh Sidhu, Contact, 647-456-2808, [email protected]
Recruiting
Allergy Research Canada, Niagara Falls, Ontario, L2H 1H5, Canada
Vipul Jain, Contact, 289-241-0577, [email protected]
Recruiting
Red Maple Trials, Ottawa, Ontario, K1H 1E4, Canada
William Yang, Contact, 613-368-4320, [email protected]
Recruiting
Quebec
Centre de Recherche Saint-Louis - Montréal, Montreal, Quebec, H1Y 3L1, Canada
Catherine Tremblay, Contact, 418 780-3501, [email protected]
Recruiting
Centre de Recherche Saint-Louis, Québec, Quebec, G1W 4R4, Canada
Virginie Kelly, Contact, 418-780-3501, [email protected]
Recruiting
Osaka
Dermatology and Ophthalmology Kume Clinic, Sakai, Osaka, 5938324, Japan
Akihiro Kume, Contact, +81-72-260-1241, [email protected]
Recruiting
Yoshikawa Skin Clinic, Takatsuki, Osaka, 5690824, Japan
Takeshi Yoshikawa, Contact, +81-72-694-2636, [email protected]
Recruiting
Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, 5698686, Japan
Completed
Tokyo
Mita Dermatology, Minato-Ku, Tokyo, 1080014, Japan
Completed
ThinkPark Dermatology Clinic, Shinagawa-Ku, Tokyo, 1416003, Japan
Completed
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic, Tachikawa, Tokyo, 1900023, Japan
Hideki Ito, Contact, +81-42-843-1377, [email protected]
Recruiting
Ikebukuro Nishiguchi Fukurou Dermatology, Toshima-ku, Tokyo, 1710021, Japan
Tomoko Fujimoto, Contact, +81-3-3590-2960, [email protected]
Recruiting