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Monoclonal Antibodies

Barzolvolimab for Chronic Hives

Phase 2

Waitlist Available

Research Sponsored by Celldex Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine

Normal blood counts and liver function tests

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to day 85 (week 12)

Awards & highlights

Study Summary

This trial will study the effectiveness, safety, and how the body processes a new drug for chronic hives.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the injection site, headaches, fatigue, nausea. The trial will closely monitor patients' health for any adverse reactions related to barzolvolimab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chronic hives despite taking regular allergy medication.

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My blood and liver tests are normal.

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I have been on a stable dose of a non-drowsy allergy medication for at least 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to day 85 (week 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to day 85 (week 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to day 85 (week 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

Secondary outcome measures

Angioedema

Urticaria

Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)

Trial Design

6Treatment groups

Experimental Treatment

Group I: barzolvolimab 75 mg then 300 mgExperimental Treatment1 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 mgExperimental Treatment1 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 mgExperimental Treatment1 Intervention

barzolvolimab 300 mg injection subcutaneous every 8 weeks for 52 weeks

Group IV: barzolvolimab 150 mgExperimental Treatment1 Intervention

barzolvolimab 150 mg injection subcutaneous every 4 weeks for 52 weeks

Group V: Placebo then barzolvolimab 300 mgExperimental Treatment2 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 mgExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Matching Placebo

2012

Completed Phase 4

~10710

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor

61 Previous Clinical Trials

3,742 Total Patients Enrolled

1 Trials studying Chronic Urticaria

45 Patients Enrolled for Chronic Urticaria

Media Library

barzolvolimab (CDX-0159) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368285 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has barzolvolimab received the sanction of the FDA?

"Taking into consideration the Phase 2 status of barzolvolimab, our group at Power has assigned it a score of 2 for safety. Although there is some data which supports its safety, no evidence exists to back up its efficacy."

Answered by AI

Are there any centers in North America that are presently conducting this clinical investigation?

"Presently, this research is running at 14 sites in Centennial, Kerrville and Montgomery as well as 11 other places. If you choose to take part it would be wise to select the closest site so that travelling costs can be reduced."

Answered by AI

How many participants have been enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov shows that this medical study, initially posted on May 19th 2022, is still actively looking for patients to enroll. 168 participants are needed from 14 different healthcare locations across the US."

Answered by AI

Is there still room to participate in this trial for those seeking treatment?

"Affirmative. According to the clinicaltrials.gov database, this medical trial is looking for 168 participants at 14 sites and has been active since May 19th 2022. The latest update was released on November 10th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

2022. "A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05368285.

All > Chronic Spontaneous Urticaria