Barzolvolimab for Cold Hives and Skin Writing
(EMBARQ Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called barzolvolimab, an experimental drug, to determine its effectiveness and safety for people with cold hives or skin writing (symptomatic dermographism). These conditions cause uncomfortable hives or welts triggered by cold or skin pressure, and the study focuses on patients who continue to experience symptoms despite using antihistamines. Participants will receive either the treatment or a placebo to compare results. The trial seeks individuals who have had hives for at least three months despite taking antihistamines and who can maintain a symptom diary and attend regular study visits. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
You need to stay on a stable regimen of second generation non-sedating H1-antihistamines for at least 4 weeks before starting the study treatment. The trial does not specify if you need to stop other medications, so it's best to discuss this with the study doctor.
Is there any evidence suggesting that barzolvolimab is likely to be safe for humans?
Research has shown that barzolvolimab is safe for people with cold-induced urticaria, also known as cold hives. One study found that participants tolerated the treatment well, with no major safety concerns. Most side effects were mild and short-lived.
For those with symptomatic dermographism, a condition where writing on the skin causes welts, barzolvolimab was also well tolerated. Previous studies have shown that the treatment did not cause serious problems, and any side effects were usually mild.
Overall, the evidence suggests that barzolvolimab is a safe option for both conditions, with most side effects being minor and temporary.12345Why do researchers think this study treatment might be promising for cold hives and skin writing?
Unlike the standard treatments for cold-induced urticaria and symptomatic dermographism, which often involve antihistamines or corticosteroids, Barzolvolimab is a monoclonal antibody that targets the immune system's pathways more directly. Researchers are excited about Barzolvolimab because it works by inhibiting a protein called KIT, which plays a role in triggering these skin reactions. This targeted approach could provide a more effective and longer-lasting relief from symptoms, with potentially fewer side effects than traditional therapies.
What evidence suggests that barzolvolimab might be an effective treatment for cold hives and skin writing?
Research has shown that barzolvolimab yields promising results for treating cold hives and skin writing. In this trial, participants with Cold Induced Urticaria will receive either barzolvolimab or a placebo. Earlier studies found that up to 66% of patients with cold hives fully responded to barzolvolimab, compared to just 16% who took a placebo. For participants with Symptomatic Dermographism, the trial will also compare barzolvolimab to a placebo. Previous research indicated that 49% of patients with skin writing had a complete response to barzolvolimab, while only 10% of those on placebo did. These benefits lasted for up to 20 weeks. The treatment has shown significant improvements in symptoms, offering hope for those who do not respond to antihistamines.12346
Are You a Good Fit for This Trial?
Adults over 18 with chronic urticaria, specifically cold induced or symptomatic dermographism uncontrolled by H1-antihistamines can join. They must have a positive ice-cube test for cold urticaria or meet specific criteria for dermographism, stable antihistamine use, normal blood and liver tests, agree to contraception if applicable, and be willing to keep a symptom diary.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive barzolvolimab or placebo injections every 4 weeks for 24 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 trial is testing Barzolvolimab against a placebo in adults who don't get relief from standard allergy meds. It's randomized and double-blind so neither the participants nor the researchers know who gets the real drug versus placebo until after results are collected.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks
barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks
Placebo injection subcutaneously every 4 weeks for 24 weeks
Placebo injection subcutaneously every 4 weeks for 24 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-results-barzolvolimab-phase-2-study-coldCelldex Presents Results from Barzolvolimab Phase 2 ...
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, ...
2.
ir.celldex.com
ir.celldex.com/news-releases/news-release-details/celldex-initiates-global-registrational-phase-3-programRelease Details
These effects were sustained through the end of the treatment period (20 weeks) with up to 78% of patients with ColdU and 58% of patients with ...
r097 sustained efficacy and safety of barzolvolimab in cindu
Barzolvolimab demonstrated statistically significant and clinically significant efficacy at 20 weeks in ColdU and SD, with many patients opting to continue ...
Positive efficacy and favorable safety of barzolvolimab in ...
The study met the primary endpoint with unprecedented, clinically meaningful, and statistically significant complete response rates (negative provocation test) ...
NCT07266402 | A Study to Investigate Efficacy, Safety and ...
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in ...
Positive efficacy and favorable safety of barzolvolimab in ...
This phase II barzolvolimab study is the first large, randomized placebo-controlled study to achieve a successful outcome for CIndU.
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