Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07256392 · ClinicalTrials.gov registry record · Phase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
A Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Celldex Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,370
- Enrollment target
- 9
- Study locations
NCT07256392: Recruiting Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Celldex Therapeutics.
NCT07256392 is a Phase 3 study of Chronic Spontaneous Urticaria that is actively recruiting participants, run by Celldex Therapeutics. The registered enrollment target is 1,370 participants, roughly in line with the 1,351-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target. The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07256392, a Phase 3 study of Chronic Spontaneous Urticaria, is actively recruiting participants, sponsored by Celldex Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,370 participants
- Enrollment target
- 9
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- OTHER Standard of Care
- BIOLOGICAL barzolvolimab
Study Locations (9)
Florida
- Direct Helpers Research Center - Hialeah
- Deluxe Health Center - Miami Lakes
- Advanced Clinical Research Institute (ACRI) - Florida - Tampa
Arizona
- Center for Dermatology & Plastic Surgery - Avacare - Scottsdale
California
- Dermatology Research Associates - Los Angeles
Georgia
- Centricity Research Columbus Dermatology - Columbus
Maryland
- Institute for Asthma and Allergy - Wheaton
Missouri
- Michigan Center for Research Co., LLC (or Profound Research LLC at Clarkson Medical Group as listed in Suvoda) - Clarkson
Ohio
- Bexley Dermatology Research - Bexley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,370 participants |
| Start Date | 2025-11-25 |
| Est. Completion | 2028-09 |
| Phase | Phase 3 |
What NCT07256392 shows while recruiting
NCT07256392 is an interventional study that assigns participants to a tested intervention. Its 1,370 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,351-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target.
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT07256392 lists 9 locations in 7 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT07256392 about?
NCT07256392 is a clinical study titled "Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria". 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 ...
What is the current status of trial NCT07256392?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,370 participants. The study started on 2025-11-25. Estimated completion is 2028-09.
What conditions does trial NCT07256392 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT07256392?
The interventions under investigation include: Standard of Care (OTHER), barzolvolimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT07256392?
This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07256392 being conducted?
This trial has 9 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Spontaneous Urticaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07256392's enrollment target sits among peer trials
1,370 3rd of 18 higher than 16 of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
RECRUITING · Phase 3
-
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
ACTIVE NOT RECRUITING · Phase 3
-
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
ACTIVE NOT RECRUITING · Phase 3
-
An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
ACTIVE NOT RECRUITING · Phase 3
-
A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.
COMPLETED · Phase 3
-
A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04489238 · 1,366 participants
Collection of Information to Better Understand Young Onset Colorectal Cancer
- NCT02677064 · 1,365 participants
Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
- NCT06651281 · 1,380 participants · Phase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
- NCT05245227 · 1,358 participants · Phase 3
Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI