Barzolvolimab for Chronic Hives

Recruiting at 70 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

208 Participants Needed

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.

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

Timeline

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

Treatment Details

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).

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