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A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
NCT06445023 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- BIOLOGICAL barzolvolimab
- BIOLOGICAL Matching placebo
Study Locations (20)
California
- First OC Dermatology - Fountain Valley — Fountain Valley
- 310 Clinical Research — Inglewood
- Dermatology Research Associates — Los Angeles
- Focus Clinical Research - Los Angeles — Los Angeles
- Cura Clinical Research — Oxnard
- Allergy and Asthma Consultants — Redwood City
- Acclaim Clinical Research — San Diego
- West Dermatology Research Center — San Diego
- Therapeutics Clinical Research — San Diego
- Orso Health, Inc. — Torrance
- Integrated Research of Inland, Inc. — Upland
Florida
- Encore Medical Research Boynton Beach — Boynton Beach
- Direct Helpers Research Center — Hialeah
- GSI Clinical Research — Margate
- International Dermatology Research Inc - Miami — Miami
- Miami Dade Medical Research Institute, LLC — Miami
- Sarasota Clinical Research — Sarasota
- GCP Global Clinical Professionals, LLC — St. Petersburg
Alabama
- Cahaba Dermatology Skin Health Center — Birmingham
Colorado
- Western States Clinical Research Inc — Wheat Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 963 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06445023
The ClinicalTrials.gov registry entry for NCT06445023 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 963 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celldex Therapeutics, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 2 interventions — of which barzolvolimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06445023 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06445023 about?
NCT06445023 is a clinical study titled "A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria". 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.
What is the current status of trial NCT06445023?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 963 participants. The study started on 2024-07-11. Estimated completion is 2027-04.
What conditions does trial NCT06445023 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06445023?
The interventions under investigation include: barzolvolimab (BIOLOGICAL), Matching placebo (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06445023?
This trial is sponsored by Celldex Therapeutics, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06445023 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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