Barzolvolimab for Chronic Urticaria

Overseen By Celldex Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Celldex Therapeutics

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

1370 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials.

This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Are You a Good Fit for This Trial?

This trial is for adults with Chronic Spontaneous Urticaria who finished the Phase 3 trials of barzolvolimab. Participants must agree to use effective contraception, have completed a year of treatment plus follow-up in prior studies, and be willing to adhere to study requirements including daily symptom tracking.

Inclusion Criteria

I agree to use effective birth control during and for 150 days after barzolvolimab treatment.

I am willing and able to follow all study rules and fill out a daily symptom diary.

I have signed the consent form.

What Are the Treatments Tested in This Trial?

Interventions

• Barzolvolimab

Trial Overview The study aims to gather long-term data on the effectiveness and safety of barzolvolimab for treating Chronic Spontaneous Urticaria. It also provides continued access to the drug for those who were part of earlier phase trials.

How Is the Trial Designed?

Group I: Group 2 Barzolvolimab Retreatment Group Experimental Treatment 1 Intervention

Barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks

Group II: Group 1 Observation Group Experimental Treatment 2 Interventions

Standard of care treatment (at least 2nd generation Type 1 antihistamines \[H1AH\] with or without other permitted background medications) for 52 weeks. For participants with worsening disease (UAS7 score of 16 or greater at any time between Weeks 0-24), barzolvolimab will be administered once as a 300 mg subcutaneous injection followed by 150 mg every 4 weeks for up to 52 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