barzolvolimab for Chronic Idiopathic Urticaria

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Idiopathic Urticariabarzolvolimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Chronic Idiopathic Urticaria

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From baseline to Day 85 (Week 12)

Week 12
Angioedema
Urticaria
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

6 Treatment Groups

barzolvolimab 300 mg
1 of 6
barzolvolimab 75 mg then 150 mg
1 of 6
barzolvolimab 75 mg then 300 mg
1 of 6
Placebo then barzolvolimab 300 mg
1 of 6
Placebo then barzolvolimab 150 mg
1 of 6
barzolvolimab 150 mg
1 of 6

Experimental Treatment

168 Total Participants · 6 Treatment Groups

Primary Treatment: barzolvolimab · Has Placebo Group · Phase 2

barzolvolimab 300 mg
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
barzolvolimab 75 mg then 150 mg
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
barzolvolimab 75 mg then 300 mg
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
Placebo then barzolvolimab 300 mgExperimental Group · 2 Interventions: Matching Placebo, barzolvolimab · Intervention Types: Drug, Biological
Placebo then barzolvolimab 150 mgExperimental Group · 2 Interventions: Matching Placebo, barzolvolimab · Intervention Types: Drug, Biological
barzolvolimab 150 mg
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Matching Placebo
2019
Completed Phase 4
~10750

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to day 85 (week 12)

Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor
57 Previous Clinical Trials
3,440 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of child-bearing potential and you agree to use highly effective contraceptives during the study and for 150 days after treatment.
You are willing and able to complete a daily symptom electronic diary and comply with study visits.