Barzolvolimab for Chronic Urticaria
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the long-term safety and effectiveness of barzolvolimab, an experimental treatment for Chronic Spontaneous Urticaria (CSU), a condition causing hives and itching without a known trigger. Participants who completed earlier study phases and still experience symptoms may qualify. The trial involves either observing standard care with antihistamines or administering barzolvolimab injections to assess condition management over a year. It aims to assist those needing ongoing treatment after past studies. Individuals who participated in a phase 3 CSU study and continue to have symptoms might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your study doctor to understand how your current medications might interact with the trial requirements.
Is there any evidence suggesting that barzolvolimab is likely to be safe for humans?
Research has shown that barzolvolimab is generally safe. Some participants experienced mild side effects, such as changes in hair color, but these were not serious. This treatment is a monoclonal antibody that targets a protein known as KIT. It has been used in people with chronic urticaria, or hives. Barzolvolimab reduces certain skin cells that cause the condition. In earlier studies, patients who took barzolvolimab saw their symptoms improve without major side effects, suggesting the treatment is generally safe.12345
Why are researchers excited about this study treatment for chronic urticaria?
Barzolvolimab is unique because it targets chronic urticaria differently than standard treatments, which typically involve second-generation Type 1 antihistamines. It works by inhibiting the c-KIT receptor, which plays a crucial role in mast cell activation, a key factor in chronic urticaria flare-ups. This targeted approach could offer better control over symptoms and potentially longer-lasting relief. Additionally, the administration method of a subcutaneous injection every four weeks provides a convenient and consistent treatment regimen. Researchers are excited about Barzolvolimab because it represents a novel mechanism that might offer relief to those unresponsive to current therapies.
What evidence suggests that barzolvolimab might be an effective treatment for chronic urticaria?
Research shows that barzolvolimab effectively treats chronic spontaneous urticaria (CSU), a condition that causes hives. In earlier studies, barzolvolimab helped patients fully recover and improved their quality of life, with benefits lasting up to 76 weeks. Many patients experienced significant symptom improvement, with some achieving complete relief. These positive effects persisted for months even after discontinuing the treatment. In this trial, participants in the Barzolvolimab Retreatment Group will receive a 300 mg subcutaneous injection of barzolvolimab, followed by 150 mg every 4 weeks for 52 weeks. Participants in the Observation Group will receive standard care, with barzolvolimab administered only if their condition worsens. Evidence suggests that barzolvolimab could be a promising option for people with CSU.15678
Are You a Good Fit for This Trial?
This trial is for adults with Chronic Spontaneous Urticaria who finished the Phase 3 trials of barzolvolimab. Participants must agree to use effective contraception, have completed a year of treatment plus follow-up in prior studies, and be willing to adhere to study requirements including daily symptom tracking.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants in Group 1 receive standard of care treatment with antihistamines for 52 weeks, with potential barzolvolimab rescue treatment if disease worsens
Barzolvolimab Retreatment
Participants in Group 2 receive barzolvolimab treatment starting with a 300 mg injection followed by 150 mg every 4 weeks for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Barzolvolimab
Trial Overview
The study aims to gather long-term data on the effectiveness and safety of barzolvolimab for treating Chronic Spontaneous Urticaria. It also provides continued access to the drug for those who were part of earlier phase trials.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Standard of care treatment (at least 2nd generation Type 1 antihistamines \[H1AH\] with or without other permitted background medications) for 52 weeks. For participants with worsening disease (UAS7 score of 16 or greater at any time between Weeks 0-24), barzolvolimab will be administered once as a 300 mg subcutaneous injection followed by 150 mg every 4 weeks for up to 52 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celldex Therapeutics
Lead Sponsor
Anthony S. Marucci
Celldex Therapeutics
Chief Executive Officer since 2008
MBA from Columbia University, MHL from Brown University
Diane C. Young
Celldex Therapeutics
Chief Medical Officer since 2019
MD from Harvard Medical School, AB in Biochemical Sciences from Harvard University
Citations
1.
ir.celldex.com
ir.celldex.com/news-releases/news-release-details/celldex-presents-unprecedented-76-week-results-barzolvolimabCelldex Presents Unprecedented 76 Week Results from ...
Barzolvolimab achieved the primary efficacy endpoint, a statistically significant mean change from baseline to Week 12 in UAS7 (weekly urticaria ...
Barzolvolimab Shows Long-Term Efficacy in Chronic ...
Barzolvolimab demonstrated sustained complete responses and improved quality of life (QOL) up to 76 weeks and 7 months after treatment concluded among patients ...
3.
ir.celldex.com
ir.celldex.com/news-releases/news-release-details/celldex-presents-results-barzolvolimab-phase-2-study-coldUp to 66% of Patients with ColdU and 49% with SD Obtain ...
Up to 66% of patients with ColdU and 49% of patients with SD obtained a complete response compared to 16% and 10% of patients on placebo, ...
Long-term Efficacy and Safety Extension (LTE) Study of ...
The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic ...
Chronic spontaneous urticaria improvements persist 28 ...
Patients with chronic spontaneous urticaria saw complete response and improved quality of life 7 months after treatment with barzolvolimab, ...
6.
ir.celldex.com
ir.celldex.com/news-releases/news-release-details/celldex-presents-additional-positive-data-demonstratingRelease Details
Barzolvolimab demonstrated a well tolerated safety profile throughout the study and KIT related tolerability events, mild hair color changes and ...
Safety and Clinical Activity of Multiple Doses ...
Barzolvolimab (BAR/CDX-0159), a monoclonal anti-KIT antibody, has been demonstrated to deplete skin MCs in chronic inducible urticaria and reduce disease ...
Anti‐KIT Barzolvolimab for Chronic Spontaneous Urticaria
We compared the efficacy and safety of four doses of barzolvolimab compared to placebo in reducing symptoms of chronic spontaneous urticaria in a randomized, ...
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