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Monoclonal Antibodies
Barzolvolimab for Hives (EMBARQ-CSU2 Trial)
Phase 3
Recruiting
Research Sponsored by Celldex Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Key
Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 (first dose) to day 477 (week 68)
Awards & highlights
Pivotal Trial
Summary
"This trial aims to see if barzolvolimab is effective, safe, and well-tolerated in adults with Chronic Spontaneous Urticaria who have not responded well to common
Who is the study for?
Adults over 18 with Chronic Spontaneous Urticaria (CSU) not well-controlled by antihistamines can join. They must have had hives for at least 6 weeks, a certain severity of symptoms, and be willing to keep a symptom diary. People with or without prior biologic treatment are eligible if they've been on stable antihistamine use for 4 weeks and have normal blood and liver tests.
What is being tested?
The trial is testing the effectiveness of Barzolvolimab against a placebo in adults with CSU whose symptoms persist despite taking non-sedating H1-antihistamines. It aims to see if this new treatment can better manage their condition.
What are the potential side effects?
Possible side effects of Barzolvolimab may include reactions at the injection site, headaches, fatigue, nausea, or more serious allergic responses. The exact side effects will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been taking a specific allergy medication regularly for at least 4 weeks.
Select...
My blood and liver tests are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from day 1 (first dose) to day 477 (week 68)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 (first dose) to day 477 (week 68)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events
Mean change from baseline in UAS7 at Week 24
Mean change from baseline in UAS7 at Week 4
+7 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Group I: barzolvolimab 300 mgExperimental Treatment1 Intervention
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks
Group II: barzolvolimab 150 mgExperimental Treatment1 Intervention
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks
Group III: Placebo then barzolvolimab 300 mgExperimental Treatment2 Interventions
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
Group IV: Placebo then barzolvolimab 150 mgExperimental Treatment2 Interventions
Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Matching placebo
2017
Completed Phase 4
~3860
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Who is running the clinical trial?
Celldex TherapeuticsLead Sponsor
64 Previous Clinical Trials
4,887 Total Patients Enrolled
3 Trials studying Chronic Urticaria
1,168 Patients Enrolled for Chronic Urticaria
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