A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
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 Sex
- 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
Allervie Clinical Research - Cullman
Cullman 4057835, Alabama 4829764 35058
Cullman 4057835, Alabama 4829764 35058
Research Solutions of Arizona PC
Litchfield Park 5302053, Arizona 5551752 85340
Litchfield Park 5302053, Arizona 5551752 85340
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
Scottsdale 5313457, Arizona 5551752 85258
Scottsdale 5313457, Arizona 5551752 85258
Center for Dermatology & Plastic Surgery
Scottsdale 5313457, Arizona 5551752 85260
Scottsdale 5313457, Arizona 5551752 85260
Kern Research, Inc.
Bakersfield 5325738, California 5332921 93301
Bakersfield 5325738, California 5332921 93301
UCLA Clinical Trials Contracts & Strategic Relations
Los Angeles 5368361, California 5332921 90024
Los Angeles 5368361, California 5332921 90024
California Allergy and Asthma Medical Group
Los Angeles 5368361, California 5332921 90025
Los Angeles 5368361, California 5332921 90025
LA Universal Research Center, Inc.
Los Angeles 5368361, California 5332921 90057
Los Angeles 5368361, California 5332921 90057
Allergy and Asthma Associates of Southern Cal
Mission Viejo 5373763, California 5332921 92691
Mission Viejo 5373763, California 5332921 92691
Huntington Asthma & Allergy Center
Pasadena 5381396, California 5332921 91107
Pasadena 5381396, California 5332921 91107
Apex Clinical Research
San Diego 5391811, California 5332921 92120
San Diego 5391811, California 5332921 92120
WR-MCCR
San Diego 5391811, California 5332921 92120
San Diego 5391811, California 5332921 92120
Raffi Tachdjian MD, Inc
Santa Monica 5393212, California 5332921 90404
Santa Monica 5393212, California 5332921 90404
Clarity Dermatology, PLLC
Castle Rock 5416329, Colorado 5417618 80109
Castle Rock 5416329, Colorado 5417618 80109
Asthma and Allergy Associates
Colorado Springs 5417598, Colorado 5417618 80907
Colorado Springs 5417598, Colorado 5417618 80907
Driven Research LLC
Coral Gables 4151871, Florida 4155751 33134
Coral Gables 4151871, Florida 4155751 33134
Palm Beach Dermatology Group
Delray Beach 4153132, Florida 4155751 33484
Delray Beach 4153132, Florida 4155751 33484
Dolphin Medical Research
Doral 4153471, Florida 4155751 33172
Doral 4153471, Florida 4155751 33172
South FL Clinical Research LLC
Miami 4164138, Florida 4155751 33165
Miami 4164138, Florida 4155751 33165
Dade Florida Clinical Research Center
Miami 4164138, Florida 4155751 33173
Miami 4164138, Florida 4155751 33173
Deluxe Health Center
Miami Lakes 4164186, Florida 4155751 33014
Miami Lakes 4164186, Florida 4155751 33014
Revival Clinical Research
Orlando 4167147, Florida 4155751 32807
Orlando 4167147, Florida 4155751 32807
International Clinical Research - FL LLC
Sanford 4172086, Florida 4155751 32771
Sanford 4172086, Florida 4155751 32771
D&H Tamarac Research Center, LLC
Tamarac 4174738, Florida 4155751 33321
Tamarac 4174738, Florida 4155751 33321
Advanced Clinical Research Institute (ACRI) - Florida
Tampa 4174757, Florida 4155751 33607
Tampa 4174757, Florida 4155751 33607
Deluxe Health Center
Tampa 4174757, Florida 4155751 33607
Tampa 4174757, Florida 4155751 33607
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa 4174757, Florida 4155751 33609
Tampa 4174757, Florida 4155751 33609
University of South Florida
Tampa 4174757, Florida 4155751 33613
Tampa 4174757, Florida 4155751 33613
Olympian Clinical Research
Tampa 4174757, Florida 4155751 33615
Tampa 4174757, Florida 4155751 33615
Lane Dermatology Research - Centricity - PPDS
Columbus 4188985, Georgia 4197000 31904
Columbus 4188985, Georgia 4197000 31904
Skin Care Physicians of Georgia
Macon 4207400, Georgia 4197000 31217
Macon 4207400, Georgia 4197000 31217
Treasure Valley Medical Research
Boise 5586437, Idaho 5596512 83706
Boise 5586437, Idaho 5596512 83706
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
Sneeze Wheeze and Itch Associates LLC
Normal 4903780, Illinois 4896861 61761
Normal 4903780, Illinois 4896861 61761
The Indiana Clinical Trials Center, PC
Plainfield 4263108, Indiana 4921868 46168
Plainfield 4263108, Indiana 4921868 46168
South Bend Clinic
South Bend 4926563, Indiana 4921868 46617
South Bend 4926563, Indiana 4921868 46617
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160-8500
Kansas City 4273837, Kansas 4273857 66160-8500
Equity Medical
Bowling Green 4285268, Kentucky 6254925 42104
Bowling Green 4285268, Kentucky 6254925 42104
Allergy & Asthma Associates
Lexington 4297983, Kentucky 6254925 40509
Lexington 4297983, Kentucky 6254925 40509
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
Baton Rouge 4315588, Louisiana 4331987 70808
Baton Rouge 4315588, Louisiana 4331987 70808
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
Towson 4371582, Maryland 4361885 21204
Towson 4371582, Maryland 4361885 21204
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
Derm Institute of Western Michigan
Caledonia 4987661, Michigan 5001836 49316
Caledonia 4987661, Michigan 5001836 49316
Clarkston Skin Research - Clarkston
Clarkston 4988997, Michigan 5001836 48346
Clarkston 4988997, Michigan 5001836 48346
Midwest Clinical Research, LLC
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63141
St Louis 4407066, Missouri 4398678 63141
Skin Specialists PC
Omaha 5074472, Nebraska 5073708 68144
Omaha 5074472, Nebraska 5073708 68144
Hudson-Essex Allergy
Belleville 5095549, New Jersey 5101760 07109
Belleville 5095549, New Jersey 5101760 07109
Impact Medical / Circuit Clinical
Paramus 5102387, New Jersey 5101760 07652
Paramus 5102387, New Jersey 5101760 07652
Impact Medical / Circuit Clinical
Riverdale 5103313, New Jersey 5101760 07457
Riverdale 5103313, New Jersey 5101760 07457
Equity Medical LLC
New York 5128581, New York 5128638 10023
New York 5128581, New York 5128638 10023
OptiSkin Medical
New York 5128581, New York 5128638 10128
New York 5128581, New York 5128638 10128
Optima Research
Boardman 5147784, Ohio 5165418 44512
Boardman 5147784, Ohio 5165418 44512
Penn State Health Milton Hershey Med Cen
Hershey 5193342, Pennsylvania 6254927 17033
Hershey 5193342, Pennsylvania 6254927 17033
Clinical Partners LLC
Johnston 8604682, Rhode Island 5224323 02919
Johnston 8604682, Rhode Island 5224323 02919
Western Sky Medical Research
El Paso 5520993, Texas 4736286 79932
El Paso 5520993, Texas 4736286 79932
Austin Institute for Clinical Research, Inc.
Pflugerville 4718711, Texas 4736286 78660
Pflugerville 4718711, Texas 4736286 78660
Rainey & Finklea San Antonio Dermatology
San Antonio 4726206, Texas 4736286 78213
San Antonio 4726206, Texas 4736286 78213
Allergy Associates of Utah - Sandy
Murray 5778755, Utah 5549030 84107
Murray 5778755, Utah 5549030 84107
Jordan Valley Dermatology Center-South Jordan
South Jordan 5781770, Utah 5549030 84095
South Jordan 5781770, Utah 5549030 84095
Kalo Clinical Research
West Valley City 5784607, Utah 5549030 84120
West Valley City 5784607, Utah 5549030 84120
More Details
- NCT ID
- NCT06455202
- 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.