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 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
Allervie Clinical Research - Cullman
Cullman, Alabama 35058
Cullman, Alabama 35058
Research Solutions of Arizona PC
Litchfield Park, Arizona 85340
Litchfield Park, Arizona 85340
Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Center for Dermatology & Plastic Surgery
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
Burke Pharmaceutical Research
Hot Springs, Arkansas 71913
Hot Springs, Arkansas 71913
Kern Research, Inc.
Bakersfield, California 93301
Bakersfield, California 93301
California Allergy and Asthma Medical Group
Los Angeles, California 90025
Los Angeles, California 90025
LA Universal Research Center, Inc.
Los Angeles, California 90057
Los Angeles, California 90057
Allergy and Asthma Associates of Southern Cal
Mission Viejo, California 92691
Mission Viejo, California 92691
University Clinical Trials
San Diego, California 92123
San Diego, California 92123
Clinical Science Institute
Santa Monica, California 90404
Santa Monica, California 90404
Raffi Tachdjian MD, Inc
Santa Monica, California 90404
Santa Monica, California 90404
Asthma and Allergy Associates
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
ClearlyDerm Boca Raton - ClinEdge - PPDS
Boca Raton, Florida 33428
Boca Raton, Florida 33428
Driven Research LLC
Coral Gables, Florida 33134
Coral Gables, Florida 33134
Dolphin Medical Research
Doral, Florida 33172
Doral, Florida 33172
Deluxe Health Center
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Allergy and Asthma Diagnostic treatment Center - CRN - PPDS
Tallahassee, Florida 32308
Tallahassee, Florida 32308
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida 33607
Tampa, Florida 33607
Deluxe Health Center
Tampa, Florida 33607
Tampa, Florida 33607
Lane Dermatology Research - Centricity - PPDS
Columbus, Georgia 31904
Columbus, Georgia 31904
Treasure Valley Medical Research
Boise, Idaho 83706
Boise, Idaho 83706
The Indiana Clinical Trials Center, PC
Plainfield, Indiana 46168
Plainfield, Indiana 46168
Henry J. Kanarek - Allergy,Asthma&Immunology
Overland Park, Kansas 66211
Overland Park, Kansas 66211
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
Towson, Maryland 21204
Towson, Maryland 21204
Derm Institute of Western Michigan
Caledonia, Michigan 49316
Caledonia, Michigan 49316
Clarkston Skin Research - Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Midwest Clinical Research, LLC
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
OptiSkin Medical
New York, New York 10128
New York, New York 10128
Optimed Research Ltd - ClinEdge - PPDS
Columbus, Ohio 43235
Columbus, Ohio 43235
Clinical Partners LLC
Johnston, Rhode Island 02919
Johnston, Rhode Island 02919
University of Texas Health McGovern Medical
Bellaire, Texas 77401-3535
Bellaire, Texas 77401-3535
Western Sky Medical Research
El Paso, Texas 79932
El Paso, Texas 79932
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas 78660
Pflugerville, Texas 78660
Rainey & Finklea San Antonio Dermatology
San Antonio, Texas 78213
San Antonio, Texas 78213
Allergy Associates of Utah - Sandy
Murray, Utah 84107
Murray, Utah 84107
Jordan Valley Dermatology Center-South Jordan
South Jordan, Utah 84095
South Jordan, Utah 84095
Kalo Clinical Research
West Valley City, Utah 84120
West Valley City, Utah 84120
Virginia Dermatology and Skin Cancer Center - Norfolk
Norfolk, Virginia 23502
Norfolk, Virginia 23502
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.