A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
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 (235)
| Facility | City | Region | Status |
|---|---|---|---|
| Cahaba Dermatology Skin Health Center | Birmingham | Alabama | |
| First OC Dermatology - Fountain Valley | Fountain Valley | California | |
| 310 Clinical Research | Inglewood | California | |
| Dermatology Research Associates | Los Angeles | California | |
| Focus Clinical Research - Los Angeles | Los Angeles | California | |
| Cura Clinical Research | Oxnard | California | |
| Allergy and Asthma Consultants | Redwood City | California | |
| Acclaim Clinical Research | San Diego | California | |
| West Dermatology Research Center | San Diego | California | |
| Therapeutics Clinical Research | San Diego | California | |
| Orso Health, Inc. | Torrance | California | |
| Integrated Research of Inland, Inc. | Upland | California | |
| Western States Clinical Research Inc | Wheat Ridge | Colorado | |
| Encore Medical Research Boynton Beach | Boynton Beach | Florida | |
| Direct Helpers Research Center | Hialeah | Florida | |
| GSI Clinical Research | Margate | Florida | |
| International Dermatology Research Inc - Miami | Miami | Florida | |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | |
| Sarasota Clinical Research | Sarasota | Florida | |
| GCP Global Clinical Professionals, LLC | St. Petersburg | Florida | |
| Paradigm Clinical Research Boise | Boise | Idaho | |
| Endeavor Health | Skokie | Illinois | |
| Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave | Indianapolis | Indiana | |
| DS Research of Kentucky, LLC | Louisville | Kentucky | |
| Allergy and Asthma Specialists PSC | Owensboro | Kentucky | |
| Clinical Trials Management LLC - Southshore Office | Metairie | Louisiana | |
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | |
| DermAssociates, LLC | Rockville | Maryland | |
| Institute For Asthma and Allergy | Wheaton | Maryland | |
| David Fivenson MD Dermatolgy PLLC | Ann Arbor | Michigan | |
| Resp Medicine Research Institute of MI | Ypsilanti | Michigan | |
| Dermatolgy and Skin Cancer Center | Lee's Summit | Missouri | |
| MediSearch, LLC | Saint Joseph | Missouri | |
| Montana Medical Research | Missoula | Montana | |
| Excel Clinical Research - Las Vegas | Las Vegas | Nevada | |
| Allergy Partners of N.J., P.C. | Ocean City | New Jersey | |
| Finger Lakes Medical Research, PLLC | Cortland | New York | |
| Sadick Research Group | New York | New York | |
| Bexley Dermatology Research | Bexley | Ohio | |
| Apex Clinical Research | Canton | Ohio |
+ 195 more sites — see the full list on the official registry below.
More Celldex Therapeutics trials in Italy
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 NCT06445023 on ClinicalTrials.gov ↗ ← All trials in Italy