Barzolvolimab for Chronic Hives

No longer recruiting at 72 trial locations

Overseen By Celldex Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Celldex Therapeutics

Must be taking: H1-antihistamines

Disqualifiers: Pregnancy, HIV, Hepatitis, Anaphylaxis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I have chronic hives despite taking regular allergy medication.

I can fill out a daily electronic diary and attend all study visits.

Your skin condition has been very severe in the 7 days before starting the treatment.

Exclusion Criteria

My chronic hives have a known cause.

I am not pregnant or nursing.

Medical condition that would cause additional risk or interfere with study procedures

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Placebo-Controlled Treatment

Participants receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo

16 weeks

Subcutaneous injections every 4 weeks

Active Treatment

All participants receive barzolvolimab, with re-randomization for those initially on 75mg or placebo

36 weeks

Subcutaneous injections every 4 or 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: barzolvolimab 75 mg then 300 mg Experimental Treatment 1 Intervention

barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 300 mg injection subcutaneous every 8 weeks for 36 weeks

Group II: barzolvolimab 75 mg then 150 mg Experimental Treatment 1 Intervention

barzolvolimab 75 mg injection subcutaneous every 4 weeks for 16 weeks and then 150 mg injection subcutaneous every 4 weeks for 36 weeks

Group III: barzolvolimab 300 mg Experimental Treatment 1 Intervention

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks

Group IV: barzolvolimab 150 mg Experimental Treatment 1 Intervention

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks

Group V: Placebo then barzolvolimab 300 mg Experimental Treatment 2 Interventions

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 300 mg injection subcutaneous every 8 weeks for 36 weeks

Group VI: Placebo then barzolvolimab 150 mg Experimental Treatment 2 Interventions

Placebo injection subcutaneous every 4 weeks for 16 weeks and then barzolvolimab 150 mg injection subcutaneous every 4 weeks for 36 weeks

Who Is Running the Clinical Trial?

Celldex Therapeutics

Lead Sponsor

Trials

66

Recruited

5,900+

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-improves

Release 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-barzolvolimab

Celldex 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12368744/

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, ...

4. ajmc.com ajmc.com/view/barzolvolimab-shows-long-term-efficacy-in-chronic-spontaneous-urticaria-improving-patient-quality-of-life

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 ...

6. jacionline.org jacionline.org/article/S0091-6749(22)02072-3/fulltext

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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05368285

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-term

Release Details 77% of patients (150 mg Q4W) treated with barzolvolimab who had angioedema at baseline were angioedema free at Week 52; Data further support ...