208 Participants Needed

Barzolvolimab for Chronic Hives

Recruiting at 70 trial locations
CT
Overseen ByCelldex Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Celldex Therapeutics
Must be taking: H1-antihistamines
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new medication called barzolvolimab to help people with Chronic Spontaneous Urticaria, a condition that causes persistent hives and itching. The medication works by calming the immune system to reduce these symptoms.

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.
See 4 more

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
See 5 more

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?
6Treatment groups
Experimental Treatment
Group I: barzolvolimab 75 mg then 300 mgExperimental Treatment1 Intervention
Group II: barzolvolimab 75 mg then 150 mgExperimental Treatment1 Intervention
Group III: barzolvolimab 300 mgExperimental Treatment1 Intervention
Group IV: barzolvolimab 150 mgExperimental Treatment1 Intervention
Group V: Placebo then barzolvolimab 300 mgExperimental Treatment2 Interventions
Group VI: Placebo then barzolvolimab 150 mgExperimental Treatment2 Interventions

Find a Clinic Near You

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

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