Actively Recruiting
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Led by Celldex Therapeutics · Updated on 2026-05-01
1370
Participants Needed
20
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Completed the previous phase 3 clinical trials CDX0159-12 or CDX0159-13
- Males and females of child-bearing potential agree to use highly effective contraception during barzolvolimab treatment and for 150 days after
- Willing and able to comply with all study requirements including completing a daily symptom electronic diary
You will not qualify if you...
- Active itchy skin condition other than chronic spontaneous urticaria
- Medical conditions that pose additional risk or interfere with study procedures
- No documented UAS7 score from Weeks 64 to 68 of the previous phase 3 trials CDX0159-12 or CDX0159-13
- Other criteria as assessed by the study doctor to confirm eligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States, 35244
Actively Recruiting
2
Center for Dermatology & Plastic Surgery - Avacare
Scottsdale, Arizona, United States, 85260
Actively Recruiting
3
Dermatology Research Associates
Los Angeles, California, United States, 90045
Actively Recruiting
4
LA Universal Research Center, Inc.
Los Angeles, California, United States, 90057
Actively Recruiting
5
Encore Medical Research of Boynton Beach LLC
Boynton Beach, Florida, United States, 33436
Actively Recruiting
6
Direct Helpers Research Center
Hialeah, Florida, United States, 33012
Actively Recruiting
7
Deluxe Health Center
Miami Lakes, Florida, United States, 33014
Actively Recruiting
8
Sarasota Clinical Research
Sarasota, Florida, United States, 34239
Actively Recruiting
9
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, United States, 33607
Actively Recruiting
10
Centricity Research Columbus Dermatology
Columbus, Georgia, United States, 31904
Actively Recruiting
11
Endeavor Health
Skokie, Illinois, United States, 60026
Actively Recruiting
12
The South Bend Clinic - Avacare
South Bend, Indiana, United States, 46617
Actively Recruiting
13
Institute for Asthma and Allergy
Wheaton, Maryland, United States, 20902
Actively Recruiting
14
Respiratory Medicine Research Institute of Michigan PLC
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
15
Michigan Center for Research Co., LLC (or Profound Research LLC at Clarkson Medical Group as listed in Suvoda)
Clarkson, Missouri, United States, 48346
Actively Recruiting
16
Montana Medical Research, Inc.
Missoula, Montana, United States, 59808
Actively Recruiting
17
Bexley Dermatology Research
Bexley, Ohio, United States, 43209
Actively Recruiting
18
Toledo Institute for Clinical Research
Toledo, Ohio, United States, 43617
Actively Recruiting
19
Cornerstone Dermatology
Coorparoo, QSL, Australia, 4151
Actively Recruiting
20
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu
Wroclaw, Poland, 54-144
Actively Recruiting
Research Team
C
Celldex Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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