A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
Condition(s) studied
Investigational drug(s) / intervention(s)
barzolvolimab: Subcutaneous Administration
Matching placebo: Matching placebo Subcutaneous Administration
Study summary
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Eligibility
Primary outcome measure(s)
- Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) — From Day 1 (first dose) to Day 85 (Week 12)
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Trial sites (245)
| Facility | City | Region | Status |
|---|---|---|---|
| Allervie Clinical Research - Cullman | Cullman | Alabama | |
| Research Solutions of Arizona PC | Litchfield Park | Arizona | |
| Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd. | Scottsdale | Arizona | |
| Center for Dermatology & Plastic Surgery | Scottsdale | Arizona | |
| Kern Research, Inc. | Bakersfield | California | |
| UCLA Clinical Trials Contracts & Strategic Relations | Los Angeles | California | |
| California Allergy and Asthma Medical Group | Los Angeles | California | |
| LA Universal Research Center, Inc. | Los Angeles | California | |
| Allergy and Asthma Associates of Southern Cal | Mission Viejo | California | |
| Huntington Asthma & Allergy Center | Pasadena | California | |
| Apex Clinical Research | San Diego | California | |
| WR-MCCR | San Diego | California | |
| University Clinical Trials | San Diego | California | |
| Clinical Science Institute | Santa Monica | California | |
| Raffi Tachdjian MD, Inc | Santa Monica | California | |
| Clarity Dermatology, PLLC | Castle Rock | Colorado | |
| Asthma and Allergy Associates | Colorado Springs | Colorado | |
| Driven Research LLC | Coral Gables | Florida | |
| Palm Beach Dermatology Group | Delray Beach | Florida | |
| Dolphin Medical Research | Doral | Florida | |
| South FL Clinical Research LLC | Miami | Florida | |
| Dade Florida Clinical Research Center | Miami | Florida | |
| Deluxe Health Center | Miami Lakes | Florida | |
| Revival Clinical Research | Orlando | Florida | |
| International Clinical Research - FL LLC | Sanford | Florida | |
| D&H Tamarac Research Center, LLC | Tamarac | Florida | |
| Advanced Clinical Research Institute (ACRI) - Florida | Tampa | Florida | |
| Deluxe Health Center | Tampa | Florida | |
| MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research | Tampa | Florida | |
| University of South Florida | Tampa | Florida | |
| Olympian Clinical Research | Tampa | Florida | |
| Lane Dermatology Research - Centricity - PPDS | Columbus | Georgia | |
| Skin Care Physicians of Georgia | Macon | Georgia | |
| Treasure Valley Medical Research | Boise | Idaho | |
| Rush University Medical Center | Chicago | Illinois | |
| Sneeze Wheeze and Itch Associates LLC | Normal | Illinois | |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | |
| South Bend Clinic | South Bend | Indiana | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Equity Medical | Bowling Green | Kentucky |
+ 205 more sites — see the full list on the official registry below.
More Celldex Therapeutics trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06455202 on ClinicalTrials.gov ↗ ← All trials in the UK