A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Purpose
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.
Conditions
- Chronic Inducible Urticaria
- Cold Urticaria
- Cold-Induced Urticaria
- Symptomatic Dermographism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Males and females, >/= 18 years of age. 2. Diagnosis of cold induced urticaria or symptomatic dermographism >/= 3 months. 3. Diagnosis of cold induced urticaria or symptomatic dermographism 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 H1-antihistamines. 2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment. 3. Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and < 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test. 4. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening 5. Normal blood counts and liver function tests. 6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment. 7. Willing and able to complete a daily symptom electronic diary and comply with study visits. 8. Participants with and without prior biologic experience are eligible.
Exclusion Criteria
- Women who are pregnant or nursing. 2. Clearly defined cause for chronic urticaria. 3. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism. 4. Medical condition that would cause additional risk or interfere with study procedures. 5. Known HIV, hepatitis B or hepatitis C infection. 6. Vaccination with a live vaccine within 30 days prior to screening (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine. 7. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water). 8. 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 in patients with Cold Induced Urticaria |
barzolvolimab 450mg injection subcutaneously at randomization , then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
|
|
Placebo Comparator Placebo in patients with Cold Induced Urticaria |
Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
|
|
Experimental barzolvolimab in patients with Symptomatic Dermographism |
barzolvolimab 450mg injection subcutaneously at randomization, then 150mg injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
|
|
Placebo Comparator Placebo in patients with Symptomatic Dermographism |
Placebo injection subcutaneously every 4 weeks for 24 weeks followed by 300mg barzolvolimab every 8 weeks for 28 weeks. |
|
Recruiting Locations
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama 35244
Birmingham, Alabama 35244
One of a Kind Clinical Research Center, LLC
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Kern Research, Inc.
Bakersfield, California 93301
Bakersfield, California 93301
One of a Kind Clinical Research Center
Napa, California 94558
Napa, California 94558
Allergy & Asthma Consultants
Redwood City, California 94063
Redwood City, California 94063
Amicis Research Center
Sherman Oaks, California 91403
Sherman Oaks, California 91403
FOMAT - Allergy, Asthma & Immunology Medical Group
Ventura, California 93003
Ventura, California 93003
Direct Helpers Research Center
Hialeah, Florida 33012
Hialeah, Florida 33012
Well Pharma Medical Research, Corp.
Miami, Florida 33143
Miami, Florida 33143
Deluxe Health Center, LLC
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
GCP, Global Clinical Professionals
St. Petersburg, Florida 33705
St. Petersburg, Florida 33705
Advanced Clinical Research Institute
Tampa, Florida 33607
Tampa, Florida 33607
Centricity Research Columbus Dermatology
Columbus, Georgia 31904
Columbus, Georgia 31904
Endeavor Health Clinical Trials Center
Skokie, Illinois 60077
Skokie, Illinois 60077
Advanced ENT and Allergy, PLLC
Louisville, Kentucky 40207
Louisville, Kentucky 40207
Equity Medical, LLC
New York, New York 10023
New York, New York 10023
Markowitz Medical PLLC dba OptiSkin Medical
New York, New York 10128
New York, New York 10128
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Advanced Dermatology and Cosmetic Surgery - Spartanburg
Spartanburg, South Carolina 29307
Spartanburg, South Carolina 29307
RFSA Dermatology
San Antonio, Texas 78212
San Antonio, Texas 78212
Allergy Associates of Utah
Sandy City, Utah 84093
Sandy City, Utah 84093
More Details
- Status
- Recruiting
- Sponsor
- Celldex Therapeutics
Detailed Description
The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria (ColdU) or symptomatic dermographism (SD) who remain symptomatic despite the use of H1-antihistamines. There is a Screening Period of up to 4 weeks, followed by a 24-week treatment period where patients will receive barzolvolimab or placebo. Patients receiving barzolvolimab will receive 450mg at the start of the treatment period and then 150mg every 4 weeks. Then there is a 28-week treatment period where all patients will receive 300mg barzolvolimab every 8 weeks, followed by a 16-week follow-up period where all patients are observed.