Barzolvolimab for Chronic Hives
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called barzolvolimab (CDX-0159) for individuals with chronic hives of unknown cause. Researchers aim to evaluate the treatment's effectiveness, safety, and movement through the body. Participants will receive varying doses of barzolvolimab or a placebo (a non-active treatment) before switching to the actual treatment. This trial targets individuals who have experienced chronic hives for over six months, despite regular antihistamine use. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial requires you to continue taking a stable regimen of second generation non-sedating H1-antihistamines for at least 4 weeks before starting the study treatment. It doesn't specify about other medications, so you should discuss this with the study doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that barzolvolimab, tested for treating chronic hives, is generally well-tolerated. Research indicates that barzolvolimab targets specific skin cells involved in hives, reducing symptoms.
In previous studies, patients experienced some side effects, mostly mild. Common side effects included headaches and mild reactions at the injection site. However, the treatment proved effective for many, with some patients reporting complete relief from symptoms like swelling under the skin after 52 weeks.
While the treatment remains under testing, current data suggest that barzolvolimab is relatively safe for humans. This trial is part of a phase that closely examines treatment tolerance, emphasizing safety as a top priority.12345Why are researchers excited about this trial's treatments?
Barzolvolimab is unique because it specifically targets the KIT receptor, which is believed to play a critical role in chronic hives, or chronic urticaria. Unlike standard treatments like antihistamines and corticosteroids, which often provide only temporary relief and can have side effects, barzolvolimab offers a novel approach by potentially altering the underlying disease mechanism. Researchers are excited because this targeted action could lead to more sustained symptom relief with fewer side effects, representing a significant advancement in managing chronic hives.
What evidence suggests that this trial's treatments could be effective for chronic hives?
Research has shown that barzolvolimab may help treat chronic spontaneous urticaria, also known as hives. Studies found that it significantly reduced hive symptoms, with patients feeling better as soon as 12 weeks into treatment. The positive effects lasted for up to 76 weeks, even several months after stopping the treatment. Barzolvolimab not only reduced hives but also improved patients' quality of life. These findings suggest that barzolvolimab could be an effective option for managing chronic hives. Participants in this trial will receive different dosages of barzolvolimab or a placebo, followed by barzolvolimab, to evaluate its effectiveness further.12678
Are You a Good Fit for This Trial?
This trial is for adults over 18 with chronic spontaneous urticaria (hives) lasting at least 6 months, who have been on a stable antihistamine regimen for over 4 weeks. Participants must not be pregnant or nursing, free from certain infections like HIV and hepatitis, and without other skin conditions or causes for their hives. They should also agree to use effective contraception and avoid live vaccines.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Placebo-Controlled Treatment
Participants receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo
Active Treatment
All participants receive barzolvolimab, with re-randomization for those initially on 75mg or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- barzolvolimab (CDX-0159)
Trial Overview
The study is testing barzolvolimab's effects on chronic spontaneous urticaria compared to a placebo. It aims to understand how well the drug works, its safety profile, how it affects the body (pharmacodynamics), and how the body processes it (pharmacokinetics).
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks
barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks
barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks
barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks
Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 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-data-demonstrating-barzolvolimab-improvesRelease Details
Barzolvolimab achieved the primary efficacy endpoint of the study—a statistically significant mean change from baseline to week 12 in UAS7 ( ...
2.
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 ...
Anti‐KIT Barzolvolimab for Chronic Spontaneous Urticaria
The efficacy assessments showed rapid and sustained improvement of urticaria symptoms from baseline to postdose timepoints with barzolvolimab doses ≥ 1.5 mg/kg, ...
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 ...
5.
clinicaltrials.gov
clinicaltrials.gov/study/NCT05405660?term=AREA%5BConditionSearch%5D(induction)&rank=2&checkSpell=A Study of CDX-0159 in Patients With Chronic Inducible ...
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients ...
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 ...
NCT05368285 | A Phase 2 Study of CDX-0159 in Patients ...
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with ...
8.
ir.celldex.com
ir.celldex.com/news-releases/news-release-details/celldex-presents-data-demonstrating-profound-long-termRelease Details
77% of patients (150 mg Q4W) treated with barzolvolimab who had angioedema at baseline were angioedema free at Week 52; Data further support ...
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