Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Public ClinicalTrials.gov record NCT07256392. 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 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
Study identification
- NCT ID
- NCT07256392
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,370 participants
Conditions and interventions
Conditions
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
- Nov 25, 2025 (Actual)
- Primary completion
- Sep 2028 (Estimated)
- Completion
- Sep 2028 (Estimated)
- Last update posted
- Oct 7, 2026
2025 – 2028
United States locations
- U.S. sites
- 43
- U.S. states
- 20
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center, LLC | Birmingham | Alabama | 35244 | — |
| Medical Research of Arizona | Scottsdale | Arizona | 85251 | — |
| Center for Dermatology & Plastic Surgery - Avacare | Scottsdale | Arizona | 85260 | — |
| Kern Research | Bakersfield | California | 93301 | — |
| Allergy and Asthma Associates of Southern California - Laguna Niguel - CRN | Laguna Niguel | California | 92677 | — |
| California Allergy and Asthma Medical Group | Los Angeles | California | 90025-7014 | — |
| Dermatology Research Associates | Los Angeles | California | 90045 | — |
| LA Universal Research Center, Inc. | Los Angeles | California | 90057 | — |
| Asthma and Allergy Associates | Colorado Springs | Colorado | 80907 | — |
| Encore Medical Research of Boynton Beach LLC | Boynton Beach | Florida | 33436 | — |
| Dolphin Medical Research | Doral | Florida | 33172 | — |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | — |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | — |
| Deluxe Health Center | Miami Lakes | Florida | 33014 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | — |
| GCP, Global Clinical Professionals | St. Petersburg | Florida | 33705 | — |
| Advanced Clinical Research Institute (ACRI) - Florida | Tampa | Florida | 33607 | — |
| Centricity Research Columbus Dermatology | Columbus | Georgia | 31904 | — |
| Endeavor Health | Skokie | Illinois | 60026 | — |
| The South Bend Clinic - Avacare | South Bend | Indiana | 46617 | — |
| Allergy and Asthma Specialists PSC | Owensboro | Kentucky | 42301 | — |
| John Hopkins University | Baltimore | Maryland | 21224 | — |
| DermAssociates, LLC | Rockville | Maryland | 20850 | — |
| Institute for Asthma and Allergy | Wheaton | Maryland | 20902 | — |
| Michigan Center for Research Co., LLC | Clarkston | Michigan | 48346 | — |
| Respiratory Medicine Research Institute of Michigan PLC | Ypsilanti | Michigan | 48197 | — |
| Midwest Clinical Research | St Louis | Missouri | 63141 | — |
| Washington University School of Medicine | St Louis | Missouri | 63141 | — |
| Montana Medical Research, Inc. | Missoula | Montana | 59808 | — |
| Allergy Partners of NJ, PC | Ocean City | New Jersey | 07712 | — |
| Markowitz Medical PLLC dba OptiSkin Medical | New York | New York | 10128 | — |
| Bexley Dermatology Research | Bexley | Ohio | 43209 | — |
| Auni Allergy | Findlay | Ohio | 45840 | — |
| Toledo Institute for Clinical Research | Toledo | Ohio | 43617 | — |
| Toledo Institute of Clinical Research | Toledo | Ohio | 43617 | — |
| Portland Allergy and Asthma | Clackamas | Oregon | 97015 | — |
| Clinical Partners LLC | Johnston | Rhode Island | 02919 | — |
| Alina Clinical Trials LLC | Dallas | Texas | 75225 | — |
| Western Sky Medical Research | El Paso | Texas | 79912 | — |
| Rainey & Finklea San Antonio (RFSA) Dermatology | San Antonio | Texas | 78213 | — |
| Allergy and Asthma Care of Waco | Waco | Texas | 76712 | — |
| Allergy Associates of Utah | Sandy City | Utah | 84093 | — |
| Kalo Clinical Research | West Valley City | Utah | 84120 | — |
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 139 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07256392, 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 Oct 7, 2026 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07256392 live on ClinicalTrials.gov.