A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Purpose
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
Condition
- Chronic Spontaneous Urticaria
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Males and females, >/= 18 years of age. 2. Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1). 3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by: 1. The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines. 2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment. 3. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to study treatment. 4. Normal blood counts and liver function tests. 5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment. 6. Willing and able to complete a daily symptom electronic diary and comply with study visits. 7. Participants with and without prior biologic experience are eligible.
Exclusion Criteria
- Women who are pregnant or nursing. 2. Chronic urticaria whose predominant manifestation is due to CIndU. 3. Other diseases associated with urticaria. 4. Active pruritic skin condition in addition to CSU. 5. Medical condition that would cause additional risk or interfere with study procedures. 6. Known HIV, hepatitis B or hepatitis C infection. 7. Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine. 8. History of anaphylaxis. 9. Prior treatment with barzolvolimab. There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental barzolvolimab 150 mg |
barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks |
|
|
Experimental barzolvolimab 300 mg |
barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks |
|
|
Experimental Placebo then barzolvolimab 150 mg |
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. |
|
|
Experimental Placebo then barzolvolimab 300 mg |
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. |
|
Recruiting Locations
Cahaba Dermatology Skin Health Center
Birmingham, Alabama 35244
Birmingham, Alabama 35244
Clear Dermatology & Aesthetics Center Scottsdale
Scottsdale, Arizona 85255
Scottsdale, Arizona 85255
First OC Dermatology - Fountain Valley
Fountain Valley, California 92708
Fountain Valley, California 92708
Dermatology Research Associates
Los Angeles, California 90045
Los Angeles, California 90045
Cura Clinical Research
Oxnard, California 93030
Oxnard, California 93030
Allergy and Asthma Consultants
Redwood City, California 94063
Redwood City, California 94063
West Dermatology Research Center
San Diego, California 92121
San Diego, California 92121
Therapeutics Clinical Research
San Diego, California 92123
San Diego, California 92123
Integrated Research of Inland, Inc.
Upland, California 91786
Upland, California 91786
Western States Clinical Research Inc
Wheat Ridge, Colorado 80033
Wheat Ridge, Colorado 80033
Encore Medical Research Boynton Beach
Boynton Beach, Florida 33436
Boynton Beach, Florida 33436
Florida Academic Centers Research
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Direct Helpers Research Center
Hialeah, Florida 33012
Hialeah, Florida 33012
International Dermatology Research Inc - Miami
Miami, Florida 33144
Miami, Florida 33144
Miami Dade Medical Research Institute, LLC
Miami, Florida 33176
Miami, Florida 33176
GCP Global Clinical Professionals, LLC
Saint Petersburg, Florida 33705
Saint Petersburg, Florida 33705
Alliance Clinical Research of Tampa
Tampa, Florida 33615
Tampa, Florida 33615
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville, Indiana 47129
Clarksville, Indiana 47129
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
Indianapolis, Indiana 46250
Indianapolis, Indiana 46250
DS Research of Kentucky, LLC
Louisville, Kentucky 40241
Louisville, Kentucky 40241
Allergy and Asthma Specialists PSC
Owensboro, Kentucky 42301
Owensboro, Kentucky 42301
Clinical Trials Management LLC - Southshore Office
Metairie, Louisiana 70006
Metairie, Louisiana 70006
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland 21224
Baltimore, Maryland 21224
DermAssociates, LLC
Rockville, Maryland 20850
Rockville, Maryland 20850
Institute For Asthma and Allergy
Wheaton, Maryland 20902
Wheaton, Maryland 20902
David Fivenson MD Dermatolgy PLLC
Ann Arbor, Michigan 48103
Ann Arbor, Michigan 48103
Oakland Hills Dermatology
Auburn Hills, Michigan 48326
Auburn Hills, Michigan 48326
Resp Medicine Research Institute of MI
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Dermatolgy and Skin Cancer Center
Lee's Summit, Missouri 64064
Lee's Summit, Missouri 64064
MediSearch, LLC
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Montana Medical Research
Missoula, Montana 59808
Missoula, Montana 59808
Allergy Partners of N.J., P.C.
Ocean City, New Jersey 07712
Ocean City, New Jersey 07712
Smith Allergy & Asthma Specialists of Central New York
Cortland, New York 13045
Cortland, New York 13045
Sadick Research Group
New York, New York 10075
New York, New York 10075
Bexley Dermatology Research
Bexley, Ohio 43209
Bexley, Ohio 43209
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
Wright State Physicians
Fairborn, Ohio 45324
Fairborn, Ohio 45324
Apex Clinical Research Center
Mayfield Heights, Ohio 44124
Mayfield Heights, Ohio 44124
Toledo Institute of Clinical Research
Toledo, Ohio 43617
Toledo, Ohio 43617
Southern Plains Medical Center - Chickasha
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Portland Allergy and Asthma
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Oregon Medical Research Center
Portland, Oregon 97201
Portland, Oregon 97201
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania 18114
Philadelphia, Pennsylvania 18114
National Allergy and Asthma Research, LLC - CRN - PPDS
North Charleston, South Carolina 29420
North Charleston, South Carolina 29420
VAST Clinical Research - Plano
Plano, Texas 75033
Plano, Texas 75033
Allergy and Asthma Care of Waco
Waco, Texas 76712
Waco, Texas 76712
More Details
- NCT ID
- NCT06445023
- Status
- Recruiting
- Sponsor
- Celldex Therapeutics
Detailed Description
This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.