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 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
Cahaba Dermatology Skin Health Center
Birmingham 4049979, Alabama 4829764 35244
Birmingham 4049979, Alabama 4829764 35244
Clear Dermatology & Aesthetics Center Scottsdale
Scottsdale 5313457, Arizona 5551752 85255
Scottsdale 5313457, Arizona 5551752 85255
First OC Dermatology - Fountain Valley
Fountain Valley 5350207, California 5332921 92708
Fountain Valley 5350207, California 5332921 92708
310 Clinical Research
Inglewood 5359488, California 5332921 90301
Inglewood 5359488, California 5332921 90301
Dermatology Research Associates
Los Angeles 5368361, California 5332921 90045
Los Angeles 5368361, California 5332921 90045
Focus Clinical Research - Los Angeles
Los Angeles 5368361, California 5332921 91307
Los Angeles 5368361, California 5332921 91307
Cura Clinical Research
Oxnard 5380184, California 5332921 93030
Oxnard 5380184, California 5332921 93030
Allergy and Asthma Consultants
Redwood City 5386834, California 5332921 94063
Redwood City 5386834, California 5332921 94063
Acclaim Clinical Research
San Diego 5391811, California 5332921 92120
San Diego 5391811, California 5332921 92120
West Dermatology Research Center
San Diego 5391811, California 5332921 92121
San Diego 5391811, California 5332921 92121
Therapeutics Clinical Research
San Diego 5391811, California 5332921 92123
San Diego 5391811, California 5332921 92123
Orso Health, Inc.
Torrance 5403022, California 5332921 90505
Torrance 5403022, California 5332921 90505
Integrated Research of Inland, Inc.
Upland 5404915, California 5332921 91786
Upland 5404915, California 5332921 91786
Western States Clinical Research Inc
Wheat Ridge 5443948, Colorado 5417618 80033
Wheat Ridge 5443948, Colorado 5417618 80033
Encore Medical Research Boynton Beach
Boynton Beach 4148677, Florida 4155751 33436
Boynton Beach 4148677, Florida 4155751 33436
Florida Academic Centers Research
Coral Gables 4151871, Florida 4155751 33134
Coral Gables 4151871, Florida 4155751 33134
Direct Helpers Research Center
Hialeah 4158476, Florida 4155751 33012
Hialeah 4158476, Florida 4155751 33012
GSI Clinical Research
Margate 4163407, Florida 4155751 33063
Margate 4163407, Florida 4155751 33063
International Dermatology Research Inc - Miami
Miami 4164138, Florida 4155751 33144
Miami 4164138, Florida 4155751 33144
Miami Dade Medical Research Institute, LLC
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
Sarasota Clinical Research
Sarasota 4172131, Florida 4155751 34239
Sarasota 4172131, Florida 4155751 34239
GCP Global Clinical Professionals, LLC
St. Petersburg 4171563, Florida 4155751 33705
St. Petersburg 4171563, Florida 4155751 33705
Paradigm Clinical Research Boise
Boise 5586437, Idaho 5596512 83709
Boise 5586437, Idaho 5596512 83709
Endeavor Health
Skokie 4911600, Illinois 4896861 60077
Skokie 4911600, Illinois 4896861 60077
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville 4255836, Indiana 4921868 47129
Clarksville 4255836, Indiana 4921868 47129
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
Indianapolis 4259418, Indiana 4921868 46250
Indianapolis 4259418, Indiana 4921868 46250
DS Research of Kentucky, LLC
Louisville 4299276, Kentucky 6254925 40241
Louisville 4299276, Kentucky 6254925 40241
Allergy and Asthma Specialists PSC
Owensboro 4303436, Kentucky 6254925 42301
Owensboro 4303436, Kentucky 6254925 42301
Clinical Trials Management LLC - Southshore Office
Metairie 4333177, Louisiana 4331987 70006
Metairie 4333177, Louisiana 4331987 70006
Johns Hopkins Asthma and Allergy Center
Baltimore 4347778, Maryland 4361885 21224
Baltimore 4347778, Maryland 4361885 21224
DermAssociates, LLC
Rockville 4367175, Maryland 4361885 20850
Rockville 4367175, Maryland 4361885 20850
Institute For Asthma and Allergy
Wheaton 4373349, Maryland 4361885 20902
Wheaton 4373349, Maryland 4361885 20902
David Fivenson MD Dermatolgy PLLC
Ann Arbor 4984247, Michigan 5001836 48103
Ann Arbor 4984247, Michigan 5001836 48103
Oakland Hills Dermatology
Auburn Hills 4984565, Michigan 5001836 48326
Auburn Hills 4984565, Michigan 5001836 48326
Resp Medicine Research Institute of MI
Ypsilanti 5015688, Michigan 5001836 48197
Ypsilanti 5015688, Michigan 5001836 48197
Dermatolgy and Skin Cancer Center
Lee's Summit 4394870, Missouri 4398678 64064
Lee's Summit 4394870, Missouri 4398678 64064
MediSearch, LLC
Saint Joseph 4407010, Missouri 4398678 64506
Saint Joseph 4407010, Missouri 4398678 64506
Montana Medical Research
Missoula 5666639, Montana 5667009 59808
Missoula 5666639, Montana 5667009 59808
Excel Clinical Research - Las Vegas
Las Vegas 5506956, Nevada 5509151 90301
Las Vegas 5506956, Nevada 5509151 90301
Allergy Partners of N.J., P.C.
Ocean City 4503351, New Jersey 5101760 07712
Ocean City 4503351, New Jersey 5101760 07712
Sadick Research Group
New York 5128581, New York 5128638 10075
New York 5128581, New York 5128638 10075
Bexley Dermatology Research
Bexley 4506487, Ohio 5165418 43209
Bexley 4506487, Ohio 5165418 43209
Apex Clinical Research
Canton 5149222, Ohio 5165418 44718
Canton 5149222, Ohio 5165418 44718
Bernstein Clinical Research Center, LLC
Cincinnati 4508722, Ohio 5165418 45236
Cincinnati 4508722, Ohio 5165418 45236
Wright State Physicians
Fairborn 4511263, Ohio 5165418 45324
Fairborn 4511263, Ohio 5165418 45324
Auni Allergy
Findlay 5153924, Ohio 5165418 45840
Findlay 5153924, Ohio 5165418 45840
Apex Clinical Research Center
Mayfield Heights 5162188, Ohio 5165418 44124
Mayfield Heights 5162188, Ohio 5165418 44124
Toledo Institute of Clinical Research
Toledo 5174035, Ohio 5165418 43617
Toledo 5174035, Ohio 5165418 43617
Southern Plains Medical Center - Chickasha
Oklahoma City 4544349, Oklahoma 4544379 73112
Oklahoma City 4544349, Oklahoma 4544379 73112
Allergy Asthma and Clinical Research Center
Oklahoma City 4544349, Oklahoma 4544379 73120
Oklahoma City 4544349, Oklahoma 4544379 73120
Portland Allergy and Asthma
Clackamas 5719308, Oregon 5744337 97015
Clackamas 5719308, Oregon 5744337 97015
Oregon Medical Research Center
Portland 5746545, Oregon 5744337 97201
Portland 5746545, Oregon 5744337 97201
Clinical Research Philadelphia, LLC
Philadelphia 4560349, Pennsylvania 6254927 18114
Philadelphia 4560349, Pennsylvania 6254927 18114
Alina Clinical Trials
Dallas 4684888, Texas 4736286 75225
Dallas 4684888, Texas 4736286 75225
Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230
Dallas 4684888, Texas 4736286 75230
Epic Clinical Research
Lewisville 4706057, Texas 4736286 75057
Lewisville 4706057, Texas 4736286 75057
STAAMP Research, LLC - CRN
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
Allergy and Asthma Care of Waco
Waco 4739526, Texas 4736286 76712
Waco 4739526, Texas 4736286 76712
University of Utah - MidValley Dermatology - PPDS
Murray 5778755, Utah 5549030 84107
Murray 5778755, Utah 5549030 84107
Premier Clinical Research
Spokane 5811696, Washington 5815135 99202
Spokane 5811696, Washington 5815135 99202
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.