Barzolvolimab for Chronic Hives

Recruiting at70 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Celldex Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Eligibility Criteria

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

Treatment Details

Interventions

• barzolvolimab (CDX-0159) (Monoclonal Antibodies)

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).

Participant Groups

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