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RECRUITING Phase 3

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

NCT07256392 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,370 participants
Start Date 2025-11-25
Est. Completion 2028-09
Phase Phase 3

Sponsor

Celldex Therapeutics

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07256392

The ClinicalTrials.gov registry entry for NCT07256392 describes a study currently listed as 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 1,370 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 Standard of Care 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: NCT07256392 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07256392?

The interventions under investigation include: Standard of Care (OTHER), barzolvolimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07256392?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial