A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Public ClinicalTrials.gov record NCT06445023. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)
Study identification
- NCT ID
- NCT06445023
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Celldex Therapeutics
- Industry
- Enrollment
- 963 participants
Conditions and interventions
Conditions
Interventions
- Matching placebo Biological
- barzolvolimab Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 10, 2024
- Primary completion
- Sep 30, 2026
- Completion
- Mar 31, 2027
- Last update posted
- Mar 24, 2026
2024 – 2027
United States locations
- U.S. sites
- 58
- U.S. states
- 24
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cahaba Dermatology Skin Health Center | Birmingham | Alabama | 35244 | — |
| First OC Dermatology - Fountain Valley | Fountain Valley | California | 92708 | — |
| 310 Clinical Research | Inglewood | California | 90301 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| Focus Clinical Research - Los Angeles | Los Angeles | California | 91307 | — |
| Cura Clinical Research | Oxnard | California | 93030 | — |
| Allergy and Asthma Consultants | Redwood City | California | 94063 | — |
| Acclaim Clinical Research | San Diego | California | 92120 | — |
| West Dermatology Research Center | San Diego | California | 92121 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| Orso Health, Inc. | Torrance | California | 90505 | — |
| Integrated Research of Inland, Inc. | Upland | California | 91786 | — |
| Western States Clinical Research Inc | Wheat Ridge | Colorado | 80033 | — |
| Encore Medical Research Boynton Beach | Boynton Beach | Florida | 33436 | — |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | — |
| GSI Clinical Research | Margate | Florida | 33063 | — |
| International Dermatology Research Inc - Miami | Miami | Florida | 33144 | — |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | — |
| GCP Global Clinical Professionals, LLC | St. Petersburg | Florida | 33705 | — |
| Paradigm Clinical Research Boise | Boise | Idaho | 83709 | — |
| Endeavor Health | Skokie | Illinois | 60077 | — |
| Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave | Indianapolis | Indiana | 46250 | — |
| DS Research of Kentucky, LLC | Louisville | Kentucky | 40241 | — |
| Allergy and Asthma Specialists PSC | Owensboro | Kentucky | 42301 | — |
| Clinical Trials Management LLC - Southshore Office | Metairie | Louisiana | 70006 | — |
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | — |
| DermAssociates, LLC | Rockville | Maryland | 20850 | — |
| Institute For Asthma and Allergy | Wheaton | Maryland | 20902 | — |
| David Fivenson MD Dermatolgy PLLC | Ann Arbor | Michigan | 48103 | — |
| Resp Medicine Research Institute of MI | Ypsilanti | Michigan | 48197 | — |
| Dermatolgy and Skin Cancer Center | Lee's Summit | Missouri | 64064 | — |
| MediSearch, LLC | Saint Joseph | Missouri | 64506 | — |
| Montana Medical Research | Missoula | Montana | 59808 | — |
| Excel Clinical Research - Las Vegas | Las Vegas | Nevada | 90301 | — |
| Allergy Partners of N.J., P.C. | Ocean City | New Jersey | 07712 | — |
| Finger Lakes Medical Research, PLLC | Cortland | New York | 13045 | — |
| Sadick Research Group | New York | New York | 10075 | — |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | — |
| Apex Clinical Research | Canton | Ohio | 44718 | — |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45236 | — |
| Wright State Physicians | Fairborn | Ohio | 45324 | — |
| Auni Allergy | Findlay | Ohio | 45840 | — |
| Apex Clinical Research Center | Mayfield Heights | Ohio | 44124 | — |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | — |
| Allergy Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | — |
| Portland Allergy and Asthma | Clackamas | Oregon | 97015 | — |
| Oregon Medical Research Center | Portland | Oregon | 97201 | — |
| Clinical Research Philadelphia, LLC | Philadelphia | Pennsylvania | 18114 | — |
| National Allergy and Asthma Research, LLC - CRN - PPDS | North Charleston | South Carolina | 29420 | — |
| Alina Clinical Trials | Dallas | Texas | 75225 | — |
| Zenos Clinical Research | Dallas | Texas | 75230 | — |
| Epic Clinical Research | Lewisville | Texas | 75057 | — |
| VAST Clinical Research - Plano | Plano | Texas | 75033 | — |
| STAAMP Research, LLC - CRN | San Antonio | Texas | 78229 | — |
| Allergy and Asthma Care of Waco | Waco | Texas | 76712 | — |
| University of Utah - MidValley Dermatology - PPDS | Murray | Utah | 84107 | — |
| Premier Clinical Research | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 177 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06445023, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2026 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06445023 live on ClinicalTrials.gov.